Tag Archives: Put It on the Board

April 2024—Member organizations of the Enduring Consensus Cervical Cancer Screening and Management Guidelines effort released in March their recommendations for the use of p16/Ki-67 dual stain for managing individuals who test positive for HPV.

March 2024—The Food and Drug Administration approved in December the AvertD test, which assesses whether an individual may have an elevated risk of developing opioid use disorder. Its intended use is to inform the decision-making of patients and physicians about the use of oral opioids for acute pain relief.

February 2024—Members of the CAP Machine Learning Working Group, Informatics Committee, Digital and Computational Pathology Committee, and Council on Informatics and Pathology Innovation have proposed 15 recommendations for evaluating the performance of machine learning-based clinical decision support systems in pathology.

January 2024—The Association for Molecular Pathology on Dec. 14 published a joint report on what to consider for a slice testing strategy for diagnostics, including gene selection, analytic performance, coverage, quality, and interpretation. Slice testing is the practice of bioinformatically selecting a subset of genes from exome or genome sequencing assays.

December 2023—The Food and Drug Administration granted approval for EntroGen’s CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), used in the treatment of colorectal cancer.

November 2023—Roche announced last month the U.S. launch of its Cobas Connection Modules (CCM) Vertical, the elevator and overhead components of its fully automated and modular CCM system to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care.

October 2023—The Food and Drug Administration has granted clearance to Streck’s MDx-Chex for BC-GP and MDx-Chex for BC-GN for use in diagnostic procedures. They are quality controls designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for bloodstream infection and sepsis.

September 2023—A wrist-worn high-sensitivity cardiac troponin I monitor was one of the wearable devices and health monitors highlighted in a session on emerging technologies for point-of-care testing at the Association for Diagnostics and Laboratory Medicine meeting in July.

August 2023—The Association for Diagnostics and Laboratory Medicine (formerly AACC) and the American Diabetes Association last month issued guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (Sacks DB, et al. Clin Chem. 2023;69​[8]:808–868).

July 2023—Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received Food and Drug Administration 510(k) clearance. They are used as a tTau/Abeta42 ratio, which will become available in the fourth quarter of this year.

June 2023—The Association for Molecular Pathology and the National Society of Genetic Counselors released in May a report containing eight recommendations for next-generation sequencing germline variant confirmation.  

May 2023—Kaiser Foundation Hospitals and Geisinger Health announced the launch of Risant Health and a definitive agreement to make Geisinger the first health system to join Risant Health to expand access to value-based care in more communities across the country. Upon regulatory approval, Geisinger becomes part of the new organization through acquisition.

April 2023—Abbott has received FDA clearance for its Alinity i TBI laboratory test for traumatic brain injury. The test provides a result in 18 minutes to help clinicians assess concussion and triage patients.

March 2023—Roche has launched its IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with a glioma.  

February 2023—The CAP and three other organizations told the FDA in a Jan. 6 letter they are increasingly concerned that it is not recognizing updated antimicrobial susceptibility interpretive criteria, or breakpoints, in a sufficiently timely manner.  

January 2023—The Association for Molecular Pathology last month released a report on somatic variant classification using 2017 standards and guidelines for interpreting and reporting such variants, which were a consensus recommendation of the AMP, CAP, and American Society of Clinical Oncology.

December 2022—The Food and Drug Administration has approved the Ventana FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere (mirvetuximab soravtansine-gynx). Elahere is a first-in-class antibody-drug conjugate therapy developed by Immuno­Gen and approved under the FDA’s accelerated approval program for the treatment of FRα-positive platinum-resistant ovarian cancer.

November 2022—Volatile, uncertain, complex, ambiguous. Stan Schofield, president of NorDx and senior VP at MaineHealth, told Compass Group members at their September meeting in Albuquerque that those words describe the state of play for labs today.

October 2022—The Food and Drug Administration has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion-positive locally advanced or metastatic non-small cell lung cancer, RET-fusion-positive advanced or metastatic thyroid cancer, and RET-mutation-positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).

September 2022—The Food and Drug Administration on Aug. 11 granted accelerated approval to Enhertu for adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. Enhertu (AstraZeneca and Daiichi Sankyo) is the first drug approved for HER2-mutant NSCLC.

August 2022—The FDA has granted breakthrough device designation to Roche’s Elecsys Amyloid Plasma Panel for detection of early Alzheimer’s disease. It detects and measures AD biomarkers in blood plasma to indicate the need for further confirmatory testing.

July 2022—Paige has received CE-IVD and UKCA (UK Conformity Assessed) marks for its HER2Complete artificial intelligence software. In a recent study, HER2Complete was able to detect levels of HER2 expression in HER2-negative (IHC 0) and HER2-low (IHC 1+/2+) H&E-stained tissue samples, Paige said in announcing the news.

June 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) in April was granted breakthrough therapy designation for treating patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed recurrence during or within six months of completing adjuvant chemotherapy.

May 2022—The Department of Health and Human Services and the Centers for Medicare and Medicaid Services should engage laboratory stakeholders early and across the spectrum of care delivery environments before laboratory policies are implemented in public health emergencies, the Association for Molecular Pathology says in a report released April 19 titled “Economics of Testing During a Public Health Emergency: Lessons Learned from Two Years of COVID-19.”

April 2022—Cofactor Genomics announced publication of a study showing that its multianalyte biomarkers based on T cell subtype profiling (TCSP) predicted patient response to anti-PD-1 therapy in three cancers (lung, melanoma, head and neck) and outperformed the indicated PD-L1 test and tumor mutational burden (Schillebeeckx I, et al. Sci Rep. 2022;12[1]:1342).

March 2022—The CAP was one of eight pathology and laboratory organizations to endorse in a joint statement the use of the CKD-EPI 2021 race-free equations for calculating estimated glomerular filtration rate. The others are the Academy of Clinical Laboratory Physicians and Scientists, American Association of Clinical Chemistry, American Society for Clinical Pathology, Association of Pathology Chairs, Clinical Laboratory Management Association, National Independent Laboratory Association, and Society of American Federated Medical Laboratory Scientists (the views of the SAFMLS do not represent the views of the U.S. government). Following is the statement they released on Jan. 31.

February 2022—Siemens Healthineers’ Enhanced Liver Fibrosis test is available in the United States, exclusively through collaboration with Labcorp and Quest Diagnostics. This commercial availability in the U.S. follows de novo marketing authorization from the FDA in August 2021.

January 2022—The Food and Drug Administration granted 510(k) clearance for SeptiCyte Rapid, which runs on Biocartis’ molecular diagnostics Idylla platform. It’s a fully automated, rapid host-response test that distinguishes sepsis from infection-negative systemic inflammation in patients suspected of sepsis.

December 2021—In the COVID-19 pandemic and future pandemics, the existing expertise of clinical laboratories should be taken advantage of and labs should be enabled to validate and offer robust clinical assays, say the authors of “The Role of Clinical Laboratories in Emerging Pathogens—Insights from the COVID-19 Pandemic,” published Oct. 29 in JAMA Health Forum (2021;2[10]:​e213154).

November 2021—Roche has entered into separate agreements with PathAI and Ibex Medical Analytics in which the companies will jointly develop embedded image analysis workflows for pathologists.

October 2021—The Food and Drug Administration granted 510(k) clearance for use of the MeMed BV test on the point-of-need platform MeMed Key to help providers distinguish between bacterial and viral infections. The technology has been cleared for children and adults.

September 2021—Testing for chronic kidney disease in adults with hypertension and/or diabetes is low in routine clinical care, despite guideline recommendations, write the authors of a study published in Diabetes Care (Alfego D, et al. 2021;44[9]:2025–2032).

August 2021—The Association for Molecular Pathology on July 29 called on all relevant individuals and organizations to support and facilitate the sharing of molecular genetic variant data and offered recommendations.

July 2021—The FDA in May approved two new targeted therapies for non-small cell lung cancer.

June 2021—The Food and Drug Administration on March 30 allowed the use of the Binx Health IO CT/NG assay in physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.

May 2021—In an April 21 blog post, the Association for Molecular Pathology advised against routine use of SARS-CoV-2 PCR cycle threshold values to inform clinical decisions.

April 2021—In an Association for Molecular Pathology survey focused on molecular testing in oncology during the pandemic, 70 percent of 163 respondents reported having decreased or stopped the development and validation of new tests in their laboratories.

March 2021—As the U.S. fights COVID-19 and prepares for new threats, its leaders need to “motivate and support a laboratory-based testing model that enables broad and distributed production capacity,” say the authors of a “Perspective” published Jan. 21 in the New England Journal of Medicine (2021;384[3]:197–199).

February 2021—The FDA has issued an EUA for Siemens Healthineers’ IL-6 assay to measure the presence of interleukin-6 in human serum or plasma.

January 2021—AstraZeneca’s Tagrisso (osimertinib) has been approved in the U.S. for the adjuvant treatment of adult patients with early-stage EGFR-mutated non-small cell lung cancer after tumor resection with curative intent.

December 2020—Antimicrobial Susceptibility Testing: Monitoring and Trend Analysis is a new CAP program that is beginning to roll out to laboratories this month. The CDC guidance for antibiotic stewardship consists of seven core elements to address resistance-associated risks, one of which points to the importance of laboratory collaboration, communication, and AST reporting practices to the success of stewardship programs. According to this core element, the laboratory must provide information to guide discussions on the potential implementation of test interpretive criteria, such as changes in antibiotic breakpoints, that might affect antibiotic use.

November 2020—In an Association for Molecular Pathology survey, 62 percent of U.S. labs reported using only commercial testing kits with FDA EUA for SARS-CoV-2 molecular testing. Five percent reported using laboratory-developed tests only, 26 percent said they were using a combination of LDTs and EUA commercial kits, and six percent reported using LDTs, IRB-approved/non-EUA assays, and commercial kits. Less than one percent reported using a combination of LDTs and IRB-approved/non-EUA assays or a combination of IRB-approved/non-EUA assays and commercial kits.

October 2020—Siemens Healthineers will collaborate with the Centers for Disease Control and Prevention and the Joint Research Centre of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.

Roche launches Preanalytical System, announces FDA OK for HER2 Dual ISH test as CDx
September 2020—Roche launched its Cobas Prime Preanalytical System to improve efficiency in molecular diagnostics laboratories. It is now commercially available in the United States and markets accepting the CE mark. The system is designed to automate all preanalytic steps and features cross-contamination control of samples. It has track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.

August 2020—SpIntellx and CellNetix Pathology & Laboratories will collaborate to validate the SpIntellx HistoMapr-Breast Platform. The platform is the first in the companies’ larger efforts to use explainable artificial intelligence-assisted lab processes in the development of diagnostics, prognostics, therapeutic strategies, and drug development for tumor and non-tumor diseases.

AMP recommends PGx alleles for genotyping testing for warfarin response July 2020—The Association for Molecular Pathology published in May consensus, evidence-based recommendations to aid in the design, validation, and interpretation of clinical genotyping tests for the prediction of warfarin response. The new guideline on clinical warfarin sensitivity genotyping allele selection completes a series of three reports intended to facilitate testing ...

Better cancer diagnostics at core of Future of Pathology report June 2020—Leica Biosystems launched in April The Future of Pathology Expert Report written by an international panel of pathologists in consultation with health care executives, cancer stakeholders, and pathology leaders. In the report, each member of the panel—Tiffany Graham, MD, and Jerad Gardner, MD, in the U.S., and Bethany Williams, MBBS, PhD, and Matthew Clarke, MBBS, in the U.K.—addresses one of four subjects: pathology education, digital pathology and artificial intelligence, improving perceptions of pathology, and molecular pathology. The theme of the report (available at www.thefutureofpathology.com) is improving and transforming cancer diagnostics.

Clinical research registry aims to answer crucial COVID-19 questions May 2020—A Healthcare Worker Exposure Response and Outcomes Registry was launched April 13 to unite health care workers in the U.S. for rapid-cycle research. The goals of the so-called HERO registry are to engage workers in a research community, understand their experiences, and track outcomes associated with caring for patients with ...

Ortho Clinical Diagnostics in February made available its Vitros XT 3400 Chemistry System.
April 2020—Ortho Clinical Diagnostics in February made available its Vitros XT 3400 Chemistry System. The new system, like the Vitros XT 7600 Integrated System, simultaneously performs two tests frequently ordered together on one Vitros XT MicroSlide. Double assay processing offers a 25 percent faster turnaround time on a common panel of assays, Ortho said in its Feb. 26 statement, with an average processing time of 7.5 minutes. The XT MicroSlide allows for a sample volume of 2.7 μL.

March 2020—Randox has made available a test for the COVID-19 strain of coronavirus. Developed on Randox’s biochip technology, the test is an enhanced multiplex array that includes tests for COVID-19 and nine other respiratory viruses that can manifest the same symptoms. Read more.

Roche, Illumina partner to broaden access to genomic testing
February 2020—Roche has entered into a 15-year, nonexclusive partnership with Illumina to broaden the adoption of distributable next-generation-sequencing–based testing in oncology. The agreement brings together the capabilities of both companies to broaden adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic tests on Illumina’s NextSeq 550Dx system and on its future portfolio of diagnostic sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 with new companion diagnostic claims. The financial terms of the deal were not disclosed. Under the IVD terms of the agreement, Roche will develop, manufacture, and commercialize Avenio IVD tests for tissue and blood for use on Illumina’s NextSeq 550Dx. Illumina will continue to sell the NextSeq 550Dx systems and core sequencing consumables.

Ion Torrent Genexus launched at AMP meeting
January 2020—Thermo Fisher Scientific launched at the Association for Molecular Pathology meeting in November its Ion Torrent Genexus System. It is a fully integrated, next-generation sequencing platform that features an automated specimen-to-report workflow, with results provided in a single day. The company also introduced its Oncomine Precision Assay, a pan-cancer panel for the Genexus platform, for comprehensive genomic profiling from formalin-fixed, paraffin-embedded tissue and liquid biopsy samples with a single assay. The Genexus System minimizes user intervention and the potential for human error. Thermo Fisher says the system requires minimal amounts of tissue sample and can run small batches cost-effectively to deliver a comprehensive report in one day. Together, the company said in a statement, “these features set the stage for molecular pathologists in the future to analyze NGS information in parallel with first-line testing modalities such as immunohistochemistry.”

Illumina and Qiagen partner to deliver sequencing-based IVD tests
November 2019—Illumina announced on Oct. 7 a 15-year partnership intended to broaden the availability and use of NGS-based in vitro diagnostic kits, including companion diagnostics. The agreement grants Qiagen nonexclusive rights to develop and globally commercialize IVD kits to be used with Illumina’s MiSeq Dx and NextSeq 550Dx systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic systems. Both partners are also exploring opportunities for Qiagen to develop and market companion diagnostics based on Illumina’s TruSight Oncology assays. Illumina and Qiagen will cooperate to commercialize a menu of clinically validated workflows that combine Qiagen’s proprietary content and bioinformatics solutions. The partnership will focus initially on commercializing oncology IVD kits and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, and inflammatory and autoimmune diseases.

Sysmex joins Lab 2.0
October 2019—Sysmex America has joined the Clinical Lab 2.0 movement to support collaboration around value-based health care. The company said it is providing a grant focused on a multi-institutional demonstration project to develop actionable clinical strategies for anemia early detection, intervention, and prevention. Clinical Lab 2.0 is a Project Santa Fe Foundation initiative established to help develop the evidence base for the valuation of clinical laboratory services. It is a call for laboratory leadership in managing population health and enabling value-based care to evolve. Sysmex is the first corporate sponsor. “The Clinical Lab 2.0 movement, with its critical measurable and actionable attributes, promotes the clinical and business model of the future for clinical laboratories,” Khosrow Shotorbani, president and executive director of Project Santa Fe Foundation, said in a statement. The third annual Clinical Lab 2.0 Workshop will take place Nov. 3–5 in Chicago (www.cl2lab.org/clinical-lab-2-0-3rd-annual-workshop-registration-2-2/).

AMP bolsters position on consumer genomic testing
July 2019—The Association for Molecular Pathology revised its position for all consumer genomic testing. Based on a recent assessment of the current market landscape and privacy best practices, the latest position statement features an expanded list of conditions that must be met before the AMP can support a clinically meaningful test. The AMP remains neutral to all recreational, novelty, and ancestry testing that may create educational opportunities for the public. The expanded set of conditions is as follows: • All health-related claims must have well-established clinical validity. • The consumer genomic testing provider must comply with the CLIA statute and regulations. Test validation and interpretation should be performed by board-certified molecular laboratory professionals. • Information regarding the analytical and clinical validity of the tests should be present in all marketing materials and included in each report of results.

Minimum set of alleles recommended for clinical CYP2C9 genotyping
June 2019—A joint report from the CAP and the Association for Molecular Pathology was published last month to aid in the design and validation of clinical CYP2C9 assays, promote standardization of testing across different laboratories, and improve patient care. The report, “Recommendations for Clinical CYP2C9 Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was released online ahead of publication in the Journal of Molecular Diagnostics. The AMP Pharmacogenetics Working Group is developing a series of guidelines to help standardize clinical testing for frequently used genotyping assays. Developed with organizational representation from the CAP and the Clinical Pharmacogenetics Implementation Consortium, the latest report follows a set of recommendations for clinical CYP2C19 genotyping allele selection published in May 2018.

Early Sepsis Indicator receives 510(k) clearance
May 2019—Beckman Coulter’s Early Sepsis Indicator received 510(k) clearance from the Food and Drug Administration. Beckman Coulter says clinical trial findings showed that its monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care. The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis. Compared with reviewing WBC count alone, Beckman Coulter says the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves confidence in helping to rule out sepsis by 63 percent. The indicator can be used in conjunction with the company’s Multidiscipline Reflex Rules in Remisol Advance middleware.

Shield launches test 
for antibiotic susceptibility 
in N. gonorrhoeae April 2019—Shield Diagnostics launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae. “Rapid molecular testing for ciprofloxacin resistance allows for smarter medicine,” Jeffrey D. Klausner, MD, MPH, a professor of infectious disease medicine at the University of California, Los Angeles, said in a Shield statement. “Right now we’re treating gonorrhea with a sledgehammer; we’re treating everything with the same exact regimen. And it’s not a surprise that the organism will become resistant to what we’re currently using.” Ciprofloxacin can be used to treat 80 percent of infections and is 99.8 percent effective when susceptibility has been determined. Because it is administered as a single oral dose, rather than the current injectable treatment, clinicians can prescribe antibiotics for the patient to give to their partners. “Shield has launched Target-NG to help clinicians adopt a precision medicine approach to gonorrhea treatment,” said Nidhi Gupta, PhD, lead scientist on the project.

Lumipulse G β-Amyloid Ratio test has breakthrough device designation
March 2019—Fujirebio Diagnostics received on Feb. 1 breakthrough device designation from the FDA Center for Devices and Radiological Health for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test. The test uses measurable β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid and combines those concentrations into a numerical ratio of β-amyloid 1-42/β-amyloid 1-40 to estimate the presence of β-amyloid neuritic plaque pathology in the brain. The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of Lumipulse G β-amyloid 1-42 and β-amyloid 1-40 using the Lumipulse G System. The ratio results are intended to aid in assessing adult patients, ages 50 and over, who present with cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The results must be interpreted in conjunction with other diagnostic tools such as neurological examination.

Hologic assay is first FDA-cleared test to detect M. genitalium
February 2019—The Food and Drug Administration granted clearance for Hologic’s Aptima Mycoplasma genitalium assay. This is the first test the FDA has authorized for M. genitalium detection. The FDA reviewed data from a clinical study that included testing of 11,774 samples. The FDA says the study showed that the Aptima assay correctly identified M. genitalium in approximately 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified M. genitalium in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type owing to better clinical performance. Alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. genitalium present 97.8 to 99.6 percent of the time. The FDA reviewed the Aptima M. genitalium assay through the de novo premarket pathway.

FDA clears 2 of 3 ePlex blood culture ID panels:
January 2019—GenMark Diagnostics announced in December that it received FDA market clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels. GenMark’s third panel, ePlex Blood Culture Identification Gram-Negative (BCID-GN), was submitted to the FDA in September 2018 and is still under review. The fungal pathogens panel has broad coverage and includes many resistant and emerging strains, among them Candida auris, GenMark said in its statement. The company says that by coupling BCID panels with the ePlex Templated Comments software module, hospitals can enable immediate intervention linked to a diagnostic result and improve the effectiveness of antimicrobial stewardship initiatives.

12 assays for Atellica Solution:
Siemens Healthineers achieved 12 pre-market approvals from the FDA for its Atellica Solution infectious disease and oncology testing menu.

Pathologists and population health—
first steps
December 2018—Pathologists and population health—first steps: Pathologists who want to become involved in population health initiatives can take five main steps, say pathologists and laboratory leaders interviewed for an article published online last month in Archives of Pathology & Laboratory Medicine. In “The role of the pathologist in population health,” the authors report on the interviews they conducted and their review of the literature to answer several questions, among them whether pathologists in both large settings and smaller community-based settings can engage in population health (yes), and whether pathologists are in a position to analyze data for population health (“The data are there,” they say, “but getting to the data—and providing meaning out of it—is the hard part”). One of the first steps to becoming involved in any type of population health management activities, the authors write, is to understand the philosophy of the institution’s CEO and senior management.

Quest acquires PhenoPath
November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest. Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.” PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

Therascreen EGFR RGQ PCR kit approved as companion diagnostic for Vizimpro October 2018—The FDA has approved a PMA supplement expanding the labeling claim of the Qiagen Therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib). Vizimpro is for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or an exon 21 L858R mutation. The Therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (afatinib) from Boehringer Ingelheim and Iressa (gefitinib) from AstraZeneca. It is registered in more than 40 countries. This was a project governed under an agreement between Qiagen and Pfizer.

Philips introduces computational pathology software for tumor detection Royal Philips announced in September the latest release of TissueMark, which the company says now supports region of interest detection for the majority of molecular testing.

Broad-based molecular testing for NSCLC September 2018—A recently published study on broad-based genomic sequencing and survival among patients with advanced non-small cell lung cancer in the community oncology setting should not lead to the conclusion that such sequencing should be avoided in nonsquamous NSCLC, say Paul A. Bunn Jr., MD, and Dara L. Aisner, MD, PhD, of the University of Colorado Denver, Aurora. Dr. Bunn, of the Department of Medical Oncology, and Dr. Aisner, of the Department of Pathology, in an editorial published Aug. 7 in JAMA, caution readers about the study published in the same issue, which found that broad-based sequencing (more than 30 cancer genes) directly informed treatment in a minority of patients and was not independently associated with better survival. The study of 5,688 patients with advanced NSCLC was based on data acquired through abstraction and aggregation of information from the electronic medical record from 191 U.S. community oncology practices.

Cobas HPV test approved for first-line screening using SurePath preservative fluid
August 2018—Roche received FDA approval for the Cobas HPV test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It is approved for all of the screening indications supported by guidelines—primary screening in women 25 and older, reflex testing of unclear Pap test results in women 21 and older, and cotesting with a Pap test in women 30 and older—with both of the primary collection media types. “With this additional approval for the Cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types,” Ann Costello, head of Roche tissue diagnostics, said in a statement.

High-sensitivity troponin I assay available in the U.S.
July 2018—Beckman Coulter Diagnostics received 510(k) clearance from the Food and Drug Administration for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI, and the entire Access family of immunoassay systems. Access hsTnI demonstrates less than 10 percent CV at the upper reference limits for men and women and detects troponin in more than 50 percent of the healthy population. In an independent study, Access hsTnI detected more than 99 percent of troponin values for healthy men and women (Pretorius CJ, et al. Clin Biochem. 2018;​55:​49–55). “Beckman Coulter’s high-sensitivity cardiac troponin I assay can measure very low cardiac troponin concentrations with excellent precision. This test may help physicians with both the early diagnosis of myocardial infarction and future risk stratification in and outside the acute coronary syndrome setting,” Peter Kavsak, PhD, associate professor, Department of Pathology and Molecular Medicine, McMaster Uni­versity, said in a statement.

June 2018—FDA clears T2Bacteria panel for detecting sepsis-causing pathogens: T2 Biosystems received market clearance from the Food and Drug Administration for the T2Bacteria panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections.

May 2018—FDA approves osimertinib for NSCLC, nivolumab + ipilimumab for RCC: The FDA on April 18 approved osimertinib (Tagrisso, AstraZeneca) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

April 2018—CMS changes proposed policy on NGS for cancer patients: The CAP and the Association for Molecular Pathology, in separate statements in March, lauded the Centers for Medicare and Medicaid Services for revising its national coverage determination on next-generation sequencing.

March 2018—AMP issues recommendations for clinical CYP2C19 genotyping allele selection: To promote standardized testing across laboratories, the Association for Molecular Pathology published on Feb. 27 consensus, evidence-based recommendations for designing and validating clinical CYP2C19 assays.

February 2018—PreludeDx unveils predictive assay for DCIS: PreludeDx announced results from its oral presentation at the San Antonio Breast Cancer Symposium. The results using the SweDCIS randomized trial confirmed that the DCIS­ion­RT test predicts which patients with ductal carcinoma in situ will benefit from radiation therapy after breast-conserving surgery.

January 2018—Some safety issues more gray than black and white: Most laboratory safety rules are free from ambiguity. Anyone who handles specimens must wear personal protective equipment, for example. Some issues are less clearly defined, though, and require a deeper dive into the guidelines. That is where Dan Scungio, MT (ASCP), SLS, CQA(ASQ), comes in.

December 2017—FDA announces IMPACT authorization and path for authorization of other tumor profiling tests: The FDA on Nov. 15 authorized Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The IMPACT test uses next-generation sequencing to identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a tumor.

November 2017—Study finds biotin interference; FDA clears Flu A/B/RSV assay on Hologic’s Panther Fusion; FDA clears Abbott’s Alinity ci-series; Sysmex introduces CyFlow Antibodies for flow cytometry; Test approved for screening Zika in blood donations; New insights into female reproductive tract development

October 2017—Houston labs learn: know the back roads: The disaster plan of the laboratories at Memorial Hermann Health System in Houston held up well in Hurricane Harvey, thanks to lessons learned in years past, but the labs have something new to add: Know in advance the back-road access routes to the various hospitals.

September 2017—Eliminating CK-MB testing in suspected ACS: Health care leaders and clinicians should design and implement hospital-wide educational campaigns and partner with information technology and/or laboratory medicine staff at their institutions to remove CK-MB from standardized acute coronary syndrome routine order sets, say authors of a blueprint that could be a “first step to finally putting the CK-MB laboratory test to rest.”

August 2017—AML drug approved with companion diagnostic: The Food and Drug Administration approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation. The drug is approved for use with the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

July 2017—Putting pathology at the center of precision medicine: Michael H. Roehrl, MD, PhD, pathologist and director of the Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center, would like to see more joint development of companion diagnostics—pathologists and industry working together. It would lead, in his view, to better companion diagnostics.

June 2016—CMS grants Qualified Clinical Data Registry status to Pathologists Quality Registry: The Centers for Medicare and Medicaid Services has approved the CAP’s Pathologists Quality Registry as a Qualified Clinical Data Registry, or QCDR. This makes it a reporting option for pathologists in fulfilling reporting requirements under Medicare’s Quality Payment Program.

May 2017—First here, then there—FISH testing in Kenya; FDA OKs PD-L1 biomarker test for urothelial carcinoma; FDA clears Roche Cobas e 801 immunoassay module; DiaSorin granted EUA for fully automated Zika IgM test; Advia Centaur XPT has comprehensive ID menu; Roche CINtec Histology test receives FDA clearance

April 2017—At OSU, Inspirata completes deployment of WSI scanners, launches Consultation Portal: Inspirata has completed what it describes as the largest single-site deployment of whole slide image scanners at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (The James) and the Department of Pathology, both located at Ohio State University Wexner Medical Center, Columbus.

March 2017—LabCorp to acquire PAML: LabCorp, Providence Health & Services, and Catholic Health Initiatives announced Feb. 23 they have entered into a definitive agreement for LabCorp to acquire all of the ownership interest in Pathology Associates Medical Laboratories, LLC, which is owned by Providence and CHI.

February 2017—LabCorp to purchase Mount Sinai’s outreach laboratories; Philips and Illumina to offer integrated genomics solutions for oncology; Werfen, IL acquire Accriva; Abbott granted EUA for molecular Zika test; Guideline now out on CRC molecular biomarker testing

January 2017—Experts collaborate on evidence-based somatic variant classification system; FDA clears next-generation test for MRSA colonization; PMA approval granted for Aptima HIV-1 Quant; Henry Ford announces automation partnership; ArcherDX launches immune repertoire sequencing assays

SeraCare develops first multiplexed cardiomyopathy reference material: SeraCare Life Sciences has launched a multiplexed reference material for inherited disease testing by next-generation sequencing.

November 2016—FDA approves Ventana PD-L1 (SP142) assay, Access TSH (3rd IS) assay cleared for Beckman systems, Advanced MALDI-TOF use subject of AMP report, FDA clearance for Quidel Solana influenza A+B

October 2016—Cancer Moonshot has diagnostic thrust: Vice president Joe Biden’s Cancer Moonshot now has a flight plan, drafted by a blue-ribbon panel and published in September. Coming as it does in the final year of president Obama’s term in office, there are doubts about whether the ambitious $1 billion program—aimed at achieving 10 years’ progress in cancer research and treatment in a five-year period—will ever get off the launching pad.

September 2016—AMP lays out clinical utility standard for molecular Dx: The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

August 2016—LabCorp will acquire Sequenom; New York ends state PT services; St. Jude lands CAP ISO 15189 accreditation; Epigenomics’ DNA test included in CRC guideline; OSU to deploy Inspirata digital pathology solution; Mindray’s clinical chemistry analyzer cleared; Successful Keytruda trial stopped early; Top court clarifies autopsy’s place in Texas law; EUA for Siemens Zika assay

July 2016—Michel: The good, bad, and ugly that labs need to know: Robert Michel’s opening remarks at the Executive War College, which can be seen as a kind of state of the union address for laboratory medicine, focused on the trends in the industry and the opportunities and dangers they create. “Fraud and abuse. That’s the ugly,” Michel began. “Folks who are doing lab medicine the right way aren’t really aware of what’s been happening outside the walls of their laboratories.”

June 2016—Guidance seen as sign of FDA openness to digital pathology, Eco effort cuts biohazard waste, saves money, EGFR mutation liquid biopsy OK’d as companion Dx, Qiagen adds Horizon QC to next-generation system, Siemens enters molecular oncology services market, Roche PD-L1 tabbed as complementary test

May 2016—FDA approves Abbott companion diagnostic for CLL; SelectMDx study published in European Urology; Quest Zika test authorized for emergency use; Epigenomics receives FDA approval for Epi proColon; Leica to collaborate on companion diagnostic

April 2016—Logistics hurdles overcome for single Pap-HPV report: Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

March 2016—Case raises uncertainty on autopsy’s legal status: Should a hospital-provided autopsy be considered health care? It’s a question the Supreme Court of Texas will decide this spring, and its answer to that question will make a big difference—in the millions of dollars—to the claimants, Christus Health Gulf Coast v. Carswell. It could also have an impact on the medical liability coverage available to pathologists who perform autopsies in the Lone Star State.

February 2016—FDA open to whole-slide imaging as class II device: The Digital Pathology Association says that manufacturers interested in marketing whole-slide imaging devices for primary diagnosis in the U.S. should submit de novo applications to the Food and Drug Administration.

January 2016—2016 may be year of action on laboratory-developed tests: During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

December 2015—Despite launching years after the next-generation sequencing systems from Illumina and Thermo Fisher, officials at the German molecular biology company Qiagen see an opening for their GeneReader NGS offering.

November 2015—Approvals mark ‘tip of the iceberg’ for PD-L1 testing: What the FDA giveth, the FDA may taketh away. On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

Neuropathologist Dr. Omalu in spotlight at CAP ’15: Bennet Omalu, MD, MBA, MPH, who gave the spotlight event speech at CAP ’15 earlier this month, says he met retired Pittsburgh Steeler Mike Webster before conducting the 2002 autopsy that would lead to the first diagnosis of chronic traumatic encephalopathy in a National Football League player.

September 2015—Roche buys ‘sample in, susceptibility out’ technology: Roche has signed a definitive agreement to acquire Los Gatos, Calif.-based GeneWeave BioSciences, a privately held company focused on molecular clinical microbiology diagnostic solutions. The acquisition provides Roche with GeneWeave’s Smarticles technology, which quickly identifies multidrug-resistant organisms and assesses antimicrobial susceptibility directly from clinical samples without the need for traditional enrichment, culture, or sample preparation processes.

August 2015—To meet TAT goals, Vanderbilt builds ED lab: In a move expected to help meet accreditation standards on testing turnaround times for stroke and chest pain patients, Vanderbilt University Medical Center’s emergency department will gets its own satellite laboratory this month.

July 2015—Amid excitement about the groundbreaking work of unlocking the human genome’s secrets to speed diagnosis and target oncologic treatment comes the unpleasant reality that much of this labor now goes unpaid. Getting the American Medical Association’s editorial panel to publish nearly two dozen new genomics-related CPT codes for molecular pathology was a vital step, as was having those codes accepted in the Medicare clinical laboratory fee schedule.

June 2015—Keep close eye on payments to physicians; NIST releases first ‘genome in a bottle’; For blood supply safety, time for technology mandate; CE for NSCLC liquid biopsy; Siemens launches handheld coagulation analyzer

May 2015—In rare instances, NIPT finds mother’s cancer; BioFire submits de novo application for fourth panel; How patients want to get their skin biopsy results; FDA clears automated digital IFA microscope; i-Stat Total β-hCG test cleared

April 2015—Door opens on direct access to genetic tests: The FDA’s recent move to give 23and­Me permission to market this country’s first direct-to-consumer genetic test, for Bloom syndrome, goes beyond the one in 107 Jews of Ashkenazi descent who are carriers of the rare disorder.

AMP outlines laboratory view on incidental findings: The American College of Medical Genetics and Genomics’ controversial 2013 recommendations on the reporting of incidental findings on select genes was the first attempt to address the matter in the clinical setting. But the ACMG’s recommendations pose significant challenges that labs undertaking next-generation sequencing must be prepared to address, said a special report written by an Association for Molecular Pathology working group.

February 2015—Two medical organizations said that using an HPV test alone for cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology alone or cotesting with cytology and HPV testing. Pathology leaders said the multispecialty-developed guidance leaves the Pap test standing as a first-line screening option.

January 2015—Digitized slides spur patient engagement, ‘allow for democratized medicine’. Regulatory and reimbursement hurdles are key factors blocking broader adoption of digital pathology. But the technology is already having an impact, enabling patients to grasp a firmer hold of the wheel in directing their care, said Keith J. Kaplan, MD, a pathologist and laboratory medical director in Charlotte, NC.

December 2014—Crizotinib shrinks tumors in ROS1-positive NSCLC: A recently published New England Journal of Medicine study that shows promise for the treatment of ROS1-positive lung cancer patients also demonstrates the value of advanced diagnostics, says John Iafrate, MD, PhD, the article’s senior author. Thirty-six of 50 study participants whose non-small cell lung cancer was driven by a rearrangement of the ROS1 gene saw their tumors shrink significantly when they received treatment with the drug crizotinib (Xalkori). The drug suppressed tumor growth in another nine ROS1-positive patients in the study, a phase one trial.

November 2014—Amid initial confusion over Ebola-related safety protocols for health professionals providing direct patient care, laboratory professionals report hearing a consistent message from the CDC on proper specimen handling. The pressing question for laboratories is how best to approach testing with potential Ebola patients given the dual imperatives of preventing exposure and offering faster diagnostic answers.

October 2014—Leading pathologists and the CAP are encouraging laboratory professionals to use the social media website Twitter as a way to amplify lab medicine’s voice among clinicians, policymakers, news organizations, patients, and the public. It is advice that at least one prominent social media expert and nonpathology physician says lab professionals ought to heed. “Pathologists have a problem being recognized by society because we don’t see patients directly. This is an opportunity for us to get out there in society and to contribute value in that regard,” says Timothy Craig Allen, MD, JD, a newly elected member of the CAP’s Board of Governors and director of anatomic pathology at the University of Texas Medical Branch, Galveston.

September 2014—Simple blood tests, colossal contrasts on price: California hospitals have a pricing range for common blood tests so wide that it brings to mind the vast span of that state’s world wonder, the Golden Gate Bridge. Among the 150 hospitals whose blood test charges were examined in a recent study, the price for a basic metabolic test ranged from $35 to $7,303, depending on the hospital, with a median charge of $214. The biggest price difference was in charges for a lipid panel.

August 2014—Time is running short for laboratories to figure out how they will comply with a federal regulation that for the first time requires all U.S. labs to give patients their test reports within 30 days of request.

July 2014—Ethics of laboratory billing at stake in AMA’s code: Proposed revisions to the American Medical Association’s Code of Medical Ethics would remove language that supports direct billing and condemns clinicians who charge markups for laboratory or pathology services. The changes could weaken efforts to rein in billing practices that CAP leaders argue are not in the best interest of the patient and that the AMA currently defines as unethical.

June 2014—For trainees, information ‘gaps are closing’: With the dismissal of residents from training programs having led to well-known tragedies, the most recent in pathology just a year ago, attention is being paid to the importance of ensuring residents’ well-being and properly handling remediation, probation, and dismissal.

May 2014—FDA clears FilmArray GI Panel: BioMérieux affiliate BioFire received Food and Drug Administration 510(k) clearance for the FilmArray Gastrointestinal Panel. The 22-target panel allows a syndromic approach to the diagnosis of infectious diarrhea, the company says, as it includes bacteria, viruses, and parasites in one test.

April 2014—Clinical trial data and a Food and Drug Administration panel’s full-throated endorsement stand to reshape cervical cancer screening practice recommendations in the U.S. The FDA’s Microbiology Devices Advisory Committee in March voted 13-0 in favor of a new indication for Roche’s Cobas human papillomavirus test that would allow the assay to be used as a primary screen for cervical cancer in women 25 and older.

March 2014—Patient-access rule creates opportunities, costs for labs: A long-awaited Department of Health and Human Services rule that requires laboratories to provide completed test reports to patients upon request may strengthen the relationship patients have with their pathologists, but also will pose another compliance burden for labs in many states.

February 2014—When are genomic tests useful? IOM seeks answers: Collaboration among key stakeholders to set clear evidentiary standards is needed to determine the clinical utility of genome-based testing in cancer care, according to a wide variety of experts participating in an Institute of Medicine workshop. Between 1969 and 1989, genomic biomarkers were mentioned in fewer than 50,000 National Library of Medicine publications. But between 2000 and 2010, more than 250,000 articles mentioned biomarkers, said a December 2013 IOM report, “Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.”

January 2014—In a sweeping set of recommendations, the Infectious Diseases Society of America says higher federal funding and an easier regulatory pathway are needed to help encourage the development of tests that will diagnose infections more quickly and accurately.

December 2013—Illumina in November received premarket clearance from the FDA for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.

November 2013—Myriad Genetics presented last month new clinical data from a study with myRisk Hereditary Cancer, a 25-gene hereditary cancer panel, that showed a 60 percent increase in mutations detected in cancer predisposition genes in patients with a prior history of colon cancer, polyps, or both. Myriad presented this study and data from four others at the Collaborative Group of the Americas on Inherited Colorectal Cancer Annual Meeting in Anaheim, Calif.

November 2013—LifeTech names TriCore an NGS Center of Excellence: TriCore Reference Laboratories and Life Technologies have signed an agreement to establish TriCore as a regional Next-Generation Sequencing Center of Excellence. The partnership is part of Life’s initiative to establish a global alliance composed of centers capable of running the most advanced NGS-based oncology panels for clinical research.

September 2013—FDA clears Vitek MS: BioMérieux has been granted FDA 510(k) de novo clearance for Vitek MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. To gain FDA clearance, BioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates.

August 2013—FDA approves Therascreen EGFR PCR kit as companion test for Gilotrif; A guide to using the microbiology lab; Leica Biosystems acquires Kreatech; Life Tech to collaborate with Merck Serono; MDxHealth teams with HistoGeneX

July 2013—The FDA approved Abbott’s hepatitis C virus genotyping test for use in the United States. The RealTime HCV Genotype II test differentiates genotypes 1, 1a, 1b, 2, 3, 4, and 5 and is run on the automated m2000 platform. Gavin Cloherty, PhD, Abbott Molecular’s director of scientific affairs, told CAP TODAY the test has a 99.5 percent accuracy relative to sequencing and a greater than 99 percent discrimination of HCV genotype 1 subtype 1a versus 1b. Time to result for 22 samples and two controls, he said, is 5.25 hours, with 30 minutes hands-on time.

May 2013—Omnyx digital pathology OK’d for routine use in Canada, Europe; PCR platform, kit cleared for H7N9; CollabRx forms Pan Cancer molecular oncology editorial board; ‘Time for omic ancillary systems’; Thermo Fisher to acquire Life Tech; First next-generation sequencing assay for GE Healthcare; FDA clears BD Diagnostics’ C. diff assay; Foundation Medicine, Sloan-Kettering to co-develop test for hematologic cancers

April 2013—ACMG issues guidance on incidental findings: The American College of Medical Genetics and Genomics released last month its recommendations for reporting incidental findings in clinical exome and genome sequencing. An ACMG working group, working with 15 experts who served as external reviewers, specifies a set of disorders, the relevant associated genes, and certain categories of variants that should be reported, based on a consensus-driven assessment of clinical validity and utility.

March 2013—FDA clears ALK automated gene scanner; precision medicine center at Weill Cornell, NY-Presbyterian; sequence-based system cleared for HLA typing; Abbott to collaborate on companion CLL test; Cepheid, OHSU to develop oncology assays for Xpert; Clarient adopts Qiagen KRAS; test could reduce number of repeat biopsies; and Ventana, Biocare sign p63 license agreement.

February 2013—An estimate of specimen identification error; Cepheid CT/NG test classified as moderate complexity; ARUP to offer Oncimmune early-stage lung cancer test; Hologic test cleared for detecting GI pathogens; IntelligentMDx to develop tests for Qiagen platform; Latest lab vacancy data in