Editor: Frederick L. Kiechle, MD, PhD

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Q. What is the recommended procedure for analyzing cerebrospinal fluid from patients suspected of having Creutzfeldt-Jakob disease? In addition to sending the specimen to the National Prion Disease Pathology Surveillance Center for 14-3-3 testing, should the laboratory perform a cell count and/or meningitis panel?

A. April 2021—Obtaining cerebrospinal fluid from patients with clinical suspicion of prion diseases is important for the workup of these diseases. In conjunction with imaging studies and, sometimes, electroencephalography, using CSF to look for 14-3-3 protein changes and for testing with real-time quaking-induced conversion (RT-QuIC) can help distinguish prion diseases from other neurodegenerative, infectious, or autoimmune mimics, according to recent reports.^1,2 The reports demonstrate a higher sensitivity and specificity with RT-QuIC than 14-3-3. Both tests can be ordered through the National Prion Disease Pathology Surveillance Center or commercial vendors.

It may also be important to submit CSF for cell count, cytologic evaluation, and other studies if infections or neoplastic disease are part of a differential diagnosis.

1. 1. 1. Rudge P, Hyare H, Green A, Collinge J, Mead S. Imaging and CSF analyses effectively distinguish CJD from its mimics. J Neurol Neurosurg Psychiatry. 2018;89(5):461–466.
      2. Franceschini A, Baiardi S, Hughson AG, et al. High diagnostic value of second generation CSF RT-QuIC across the wide spectrum of CJD prions. Sci Rep. 2017;7(1):10655.

Brent T. Harris, MD, PhD
Director of Neuropathology
Associate Professor of Pathology and Neurology
Director, Georgetown Brain Bank
Director, Histopathology and Tissue Shared Resource
Georgetown University Medical Center
Washington, D.C.
Chair, CAP Neuropathology Committee

Q. Is light protection needed for folate samples? Most major reference laboratories do not require folate samples to be protected from light, and I could not find any studies on the topic.

A. Folate is a form of vitamin B9 that is essential for DNA synthesis and multiple metabolic reactions. It may be useful to measure serum folate in the workup of anemia and evaluation of nutritional status. Studies have demonstrated that ultraviolet light can deplete folate in vivo and in vitro and that this process depends on other components in the blood that act as photosensitizers and photoprotectors.¹ Assay instructions from several manufacturers state that folate samples should be protected from light but often do not include a reference for the recommendation.

There is limited and conflicting evidence regarding whether exposing blood tubes to light would have a significant impact on subsequent folate measurements. Komaromy-Hiller, et al., found no significant differences in folate results with up to three days of storage in light-protected and light-exposed conditions.² They concluded that folate may be light sensitive in pure form but not in serum and that serum-binding proteins may have a protective effect. More recently, Huguenin, et al., concluded that photoprotection was not necessary if the sample was measured within four hours of collection. However, the study did not involve testing after four hours.³ Clement and Kendall performed a study of light-protected versus light-exposed folate samples across seven days and found no more than a 1.7 percent decline in assayed values and no significant difference between storage conditions.⁴ Collectively, the study results suggest that routine protection from light is not necessary if folate testing is performed on site and samples are analyzed consistently within a few hours of collection.

If folate is sent to a reference laboratory, light protection may not be necessary if the sample is analyzed within a few days. Samples transported to reference laboratories in closed refrigeration or freezer boxes likely do not need special light protection (e.g. foil, wrap, or amber tubes), as short periods of light exposure pre- and post-packaging should not have significant effects on folate results. However, laboratories should defer to their respective reference laboratory specimen requirements or manufacturer package inserts. Deviating from manufacturer instructions converts the assay into a laboratory-developed test, necessitating that the assay be validated appropriately.

1. 1. 1. Juzeniene A, Thu Tam TT, Iani V, Moan J. 5-methyltetrahydrofolate can be photodegraded by endogenous photosensitizers. Free Radic Biol Med. 2009;47(8):1199–1204.
      2. Komaromy-Hiller G, Nuttall KL, Ashwood ER. Effect of storage on serum vitamin B12 and folate stability. Ann Clin Lab Sci. 1997;27(4):249–253.
      3. Huguenin A, Oudart JB, Hubert J, Maquart FX, Ramont L. Serum folate and vitamin B12: does light really matter? Clin Chem Lab Med. 2014;52(9):e203–e204.
      4. Clement NF, Kendall BK. Effect of light on vitamin B12 and folate. Lab Med. 2009;40(11):657–659.

Allison B. Chambliss, PhD, DABCC
Assistant Professor of Clinical Pathology
Keck School of Medicine of the University of Southern California
Director of Clinical Chemistry and Point-of-Care Testing
Los Angeles County + USC Medical Center
Los Angeles, Calif.
Member, CAP Clinical Chemistry Committee

Q. Many times a platelet count on an automated hematology system indicates some degree of thrombocytopenia or the analyzer reports a high mean platelet volume or platelet large cell ratio, while a blood smear shows large platelets and/or giant platelets. Is it OK to include a comment in the report that the platelets are adequate or that the count could be due to large platelets, especially with values that indicate marked thrombocytopenia?

A. Modern automated hematology analyzers usually provide accurate platelet counts, especially hematology analyzers that, in addition to using electrical impedance, use alternative methods for counting platelets, such as optical technology (light scatter or fluorescent flow cytometry) or immunologic methods. Furthermore, computer algorithms for modern hematology analyzers recognize interference or an abnormal platelet distribution.

Automated hematology analyzers will flag an automated platelet count for quantitative changes, such as when the platelet count is below or above a laboratory-defined cutoff on a new patient or delta checks show significant variation in platelet count. They will also flag an automated platelet count for qualitative changes, such as platelet clumps, abnormal platelet distribution, giant or large platelets, red blood cell fragments, or an abnormal platelet scattergram.

When a platelet count is flagged, it is important to verify the count by estimating platelets from a well-prepared peripheral blood smear. This is necessary since inaccuracy can be due to platelet characteristics that overlap those of other cellular material, such as schistocytes and leukocyte cytoplasmic fragments, the presence of cryoglobulins, and the inherent ability of platelets to activate and clump. In addition, giant platelets may not be counted by automated analyzers because their size exceeds the normal threshold value. A platelet estimate from a blood smear is an acceptable method for counting platelets. Each laboratory should develop an adequate system for correlating automated platelet counts with manual microscopic counts to prevent reporting spurious thrombocytopenia (due to platelet clumps, giant platelets, or platelet satellitism) or thrombocytosis (due to microcytic red blood cells, cytoplasmic fragments, fungal or bacterial organisms, debris, or electronic noise).

To verify the platelet count, the entire blood smear, including the feather edge, lateral edges, readable area, and thick area, should be examined under low magnification for the presence of clumps of platelets. The blood smear should then be examined under higher magnification for the presence of red cell fragments, bacterial or fungal organisms, debris, and giant platelets. If any of these interferences are present, the automated platelet count is unreliable, and a platelet scan comment should be reported in qualitative terms as normal, increased, or decreased. The comment should also mention the type of interference—for example, “normal platelet count with giant platelets present” or “normal platelet count with red cell fragments present.”

If platelets are clumped after collection in an EDTA-anticoagulated tube that was well mixed at the time of collection, this may represent in vitro EDTA-induced changes. Platelets must be quantified from blood collected directly into a counting diluent using the anticoagulant recommended by the manufacturer of the counting diluent or by estimating the count from a non-anticoagulated blood film.

D’Souza C, Briggs C, Machin SJ. Platelets: the few, the young, and the active. Clin Lab Med. 2015;35(1):123–131.

Gulati G, Song J, Florea AD, Gong J. Purpose and criteria for blood smear scan, blood smear examination, and blood smear review. Ann Lab Med. 2013;33(1):1–7.

Segal HC, Briggs C, Kunka S, et al. Accuracy of platelet counting haematology analysers in severe thrombocytopenia and potential impact on platelet transfusion. Br J Haematol. 2005;128(4):520–525.

Tantanate C, Khowawisetsut L, Pattanapanyasat K. Performance evaluation of automated impedance and optical fluorescence platelet counts compared with international reference method in patients with thalassemia. Arch Pathol Lab Med. 2017;141(6):830–836.

Olga Pozdnyakova, MD, PhD
Associate Professor of Pathology
Harvard Medical School
Medical Director, Hematology Laboratory
Brigham and Women’s Hospital
Boston, Mass.
Member, CAP Hematology/Clinical Microscopy Committee

Data analytics: from considerations to implementations

April 2021—The rewards of data analytics can be sizable, but so can the challenges of extracting data, transforming it, and loading it into the appropriate systems to facilitate the functionality.

“Analytics is born out of an idea that there have to be better ways of visualizing and using data other than simply feeding it into a spreadsheet or templated report,” says David McClintock, MD, associate chief medical information officer and associate director of pathology informatics for Michigan Medicine, at the University of Michigan. “At a minimum, we need to be able to drill down into our data to find what we need and discover what we don’t know.” Yet advancing from a desire to access data in a specified manner to delivery of data analytics can be an arduous process, he says.

Dr. McClintock and Edmunds Reineks, MD, PhD, section head of point-of-care testing at the Cleveland Clinic, shared their experiences with data analytics in separate American Association for Clinical Chemistry meeting presentations in December and in a recent conversation with CAP TODAY.

[dropcap]A[/dropcap]t the Cleveland Clinic, says Dr. Reineks, test cartridge recalls are just one example of how data analytics has led to time-saving improvements and other gains. Ten years ago, the lab’s point-of-care team might have contacted each of the hundreds of locations within the Cleveland Clinic system that were using point-of-care devices to track down recalled cartridges. Today, however, “we can pull the data, see who is using cartridges with those lot numbers, and hone in on those locations right away,” Dr. Reineks says.

While the value of such an approach is obvious, the preparation necessary to reach that point can be less so. A primary issue is that some electronic health record and laboratory information systems store data in hierarchical, or tree-like, formats instead of relational, or spreadsheet-like, formats that can be queried easily, Dr. McClintock explains. Therefore, some labs will need to find or build data analytics platforms that can interface with the former to capture and convert data so it can be readily retrieved.

“The hardest part for most of us is the data extraction,” says Dr. McClintock, who also notes that many lab systems have older database schemas “with little standardization in how they are set up, meaning they don’t lend themselves well to modern data-extraction tools.” Furthermore, the database schemas used for health care information systems can be complicated—one commonly used EHR has more than 22,000 tables—adding to the uphill battle of data extraction, he says.

Dr. Reineks recalls encountering hurdles with data extraction and transformation when he began exploring data analytics at the Cleveland Clinic. At the time, he was medical director of the core automated chemistry lab, which analyzed approximately 7,000 samples a day and produced massive amounts of data.

“One big challenge that I had was getting that information into a useful format,” he says. “Early on, that’s what I struggled with—identifying a mechanism where if I wanted to look at calcium results during a specific time period, I could quickly get that information.”

After some investigation, with the assistance of the Cleveland Clinic’s Center for Pathology Informatics, Dr. Reineks’ group helped select third-party software that solved its data-acquisition and formatting issues. About eight years ago, he recalls, the laboratory medicine department adopted Altosoft (now Kofax Altosoft), an analytics platform that can extract information from the lab system and provide pathways to customize dashboards or permit additional ad hoc analytics.

[dropcap]L[/dropcap]aboratories should select third-party software based on the analytics use case for which it is intended, Dr. McClintock says. While many labs apply analytics to LIS data, a lab may, for example, seek an analytics platform that can extract and transform data from its automation line with the objective of improving the efficiency of that line and the laboratory in general. Labs need to be precise when determining what data they want to analyze, which systems house that data, and which analytics platforms are best suited to manage that data capture and transformation, he says.

In the Cleveland Clinic’s point-of-care testing division, Dr. Reineks’ team uses a Telcor middleware solution as part of its processes to improve patient care, including to monitor quality issues and trends in patient results. During the early days of the pandemic, for example, the team retrieved Telcor-generated data from point-of-care devices that performed international normalized ratios and observed a concerning trend: Patients seemed reluctant to come to the clinic for blood tests to monitor the effectiveness of their Coumadin therapy. “Getting this data and analyzing it quickly led to the decision to implement drive-thru INR testing at several locations,” he says. “This allowed some concerned patients to continue monitoring their medication with less risk.”

Laboratorians can visualize the data they have loaded into spreadsheets by incorporating it into charts, graphs, or other models, Dr. McClintock says. If they are using analytics platforms that lack sophisticated data visualization capability, he adds, they can employ commercial tools, such as Tableau, Shiny from RStudio, Microsoft Power BI, and Plotly, for this task.

Dr. Reineks uses Tableau and the open-source visualization program Orange, among others, to create graphs, charts, and other visual representations of data. The Orange software is highly icon-driven, he says, which allows him to select data parameters and create, change, or reconfigure graphs easily.

[dropcap]B[/dropcap]efore determining whether to build or buy a data analytics package, labs need to weigh the opportunities and drawbacks for each option, Dr. McClintock says. A lab considering building an analytics platform should take into account such factors as the skill set of its information technology team and whether that team has the resources to prioritize such a project. An in-house IT team may be well versed in maintaining laboratory systems but have insufficient knowledge and software development resources to tackle a complex analytics development project, he adds.

Regardless of whether labs buy or build an analytics platform, they need to be aware that the new technology initially will add significantly to their technology team’s workload, he says. “Just because you are going with a vendor-based solution doesn’t mean you are going to pay the vendor to do everything for you,” Dr. McClintock explains. Analytics platforms typically require local servers, workstations, large displays, and interfaces, as well as system configuration, data validation, report validation, and general maintenance. “Before you know it,” he says, “you have multiple people and IT groups involved in creating new reports, supporting the system, and maintaining your data feeds.”

Laboratories that use data analytics platforms must also train their staff on how to communicate the parameters of the information the lab needs, Dr. McClintock says. “Just saying to someone, ‘I need a turnaround time report’ doesn’t work. Turnaround time for what parameters? You have to be able to detail what you really need and how you plan to use it—and put it into a concrete form business analysts can use.” This may require assigning a laboratorian with an understanding of lab informatics to translate the laboratory’s data requirements for the IT team.

[dropcap]T[/dropcap]o increase the value of data analytics, labs need to move beyond analyzing descriptive data to analyzing why things happen and, eventually, to predicting what is likely to happen and how to achieve certain outcomes, Dr. McClintock says. From a clinical perspective, he notes, it’s all about determining what data can be accessed and “what combinations we can put together to make better predictions. Everything that we are trying to do right now is a product of wanting to use our data to drive our experiences.”

To this end, Dr. McClintock cites as an example how it is more valuable for laboratories and health care systems to analyze why patients become septic than report their number of septic patients. “Further,” he says, “the power of analytics becomes more readily apparent when we can predict which patients will become septic or to change clinical practices to prevent patients from becoming septic.” However, predictive and prescriptive analytics used for such purposes as determining how to prevent medical conditions require more sophisticated algorithms. They also necessitate accessing data from outside the lab, such as nursing data, physician notes, and other clinical information. “Therefore,” Dr. McClintock says, “transitioning from descriptive analytics to more predictive and prescriptive analytics will be a big jump for many institutions.”

At least as daunting as determining how to use the data effectively is how to manage it safely, Dr. Reineks says. The Cleveland Clinic tracks every person who accesses data for analytics projects and how they use it, he notes. Furthermore, analytics and other research projects that require large data sets must receive institutional review board approval.

Even though this process may constrain or delay data analytics projects, he says, “there is good reason for it, and that is something that people need to keep in mind.” —Renee Caruthers

Sunquest introduces integrated AP and molecular reporting

Sunquest can now display ancillary molecular testing results in anatomic pathology reports generated by the Sunquest PowerPath and Sunquest CoPathPlus AP lab information systems.

Using the Sunquest Mitogen molecular and genetics laboratory information management system and Sunquest Vue visualization and reporting software, pathologists can send molecular testing results to either of the company’s AP systems to generate comprehensive reports.

Sunquest, 877-239-6337

Proscia and Ibex team up on software for prostate cancer

Proscia and Ibex Medical Analytics are collaborating on software that powers artificial intelligence-enabled workflows for prostate cancer diagnosis.

The partnership is focused on integrating Ibex’s Galen Prostate solution and Proscia’s Concentriq image- and data-management platform to bring AI-powered triaging, cancer detection, and grading of prostate core needle biopsies into routine workflows.

Galen Prostate provides real-time quality control by alerting pathologists to misdiagnosed and misgraded cancers. Concentriq is used for routine image viewing, management, and analysis and serves as a launch pad for computational applications.

The integrated solution will make Galen Prostate available to Concentriq users, beginning with select customers in the United States and Europe.

Proscia, 877-255-1341

Interpace Biosciences and Xifin extend partnership

Interpace Biosciences, a molecular testing company focused on cancer diagnosis and risk, announced that it will deploy Xifin’s Xifin RPM 12 revenue cycle-management solution enterprisewide to support its billing operations. The agreement continues a partnership between the two organizations that was forged in 2019.

The cloud-based Xifin RPM 12 solution automates the end-to-end RCM process and provides actionable insights through advanced analytics.

Xifin, 866-934-6364

LigoLab RCM tool addresses financial projections

The LigoLab LIS & RCM operating platform provides an automated accounts receivable payer projection tool for financial forecasting.

The functionality is a real-time interface that connects payers that are enrolled in electronic funds transfer with LigoLab’s revenue cycle-management module to automatically tag corresponding issue dates and posting dates and compile them into a dashboard that’s updated continuously.

LigoLab, 818-395-4659

Dr. Aller practices clinical informatics in Southern California. He can be reached at [email protected]. Dennis Winsten is founder of Dennis Winsten & Associates, Healthcare Systems Consultants. He can be reached at [email protected].

AMP reports findings on pandemic’s impact, molecular test interpretation

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.

Forty-eight percent said the turnaround time for test results increased, and 42 percent stopped or canceled plans to upgrade or buy new equipment.

Those are some of the findings of the responses to a question about the effects of the pandemic on the laboratory’s operations and its ability to perform molecular testing in oncology.

The survey was conducted between Sept. 29 and Oct. 14, 2020. Its purpose was to document how the pandemic has affected national and international labs that provide such testing. The top five countries contributing to the survey were the U.S. (59 percent), Canada (12 percent), India (six percent), Italy (three percent), and Spain (three percent).

Other immediate effects on operations, as reported by respondents who were able to select all that applied, were an inability to fill open staff positions with qualified candidates (31 percent), having taken on fewer trainees or interns (27 percent), having started to send out some tests rather than perform them in-house (25 percent), and having reduced lab staff (22 percent), among others.

The survey also aimed to understand if and how molecular testing performed for clinical trials was affected. About half of the respondents were performing molecular testing for cancer in clinical trials. Sixty-four percent of respondents that perform such testing report that the testing had been affected by the pandemic—23 percent reported a significant effect and 41 percent a slight effect.

The top two effects were a decrease in or halting of newly enrolled patients and patients being unable or reluctant to travel outside the home.

About 40 percent of respondents said the pandemic negatively affected the turnaround time for any of the molecular cancer tests their lab offers, and staffing shortages were the top reason for longer TATs.

The full AMP report is at www.amp.org/advocacy/sars-cov-2-survey.

In a separate AMP analysis released in March, on the work effort in molecular test interpretation, 103 molecular professionals from the AMP and American College of Medical Genetics and Genomics reported that their efforts spent on data analysis, interpretation, and reporting for molecular diagnostic tests were not reimbursed sufficiently. The respondents strongly agreed that access, data, and decision-making would improve with better reimbursement.

Whole genome sequencing and whole exome sequencing in human genetics were reported as the most time-consuming (seven to nine hours) for data analysis, interpretation, and reporting, along with next-generation sequencing for oncology panels of more than 50 genes (six hours).

Technical difficulty, additional research requirements, and placing test results into clinical context were rated as the greatest drivers of time burdens related to analysis and reporting.

The full results, including recommendations and next steps, are at www.amp.org/MDx_Survey_Report.

Ventana ALK (D5F3) OK’d as CDx for Lorbrena

The Food and Drug Administration approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib). It is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Lorbrena.

The assay is intended for the qualitative detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC tissue stained with a BenchMark Ultra or BenchMark XT automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with Xalkori (crizotinib), Zykadia (ceritinib), Alecensa (alectinib), or Lorbrena in the United States.

EUA requested for T-Spot.COVID test

Oxford Immunotec Global PLC released the T-Spot.COVID test, a CE-marked ELISpot-based test intended for qualitative detection of a cell-mediated (T cell) immune response to SARS-CoV-2 in human whole blood. The company said in early March it had filed an EUA request to the FDA.

In a clinical study using samples collected in the U.S., the T-​​Spot.COVID test detected a SARS-CoV-2 T-cell-mediated immune response in PCR-positive individuals, even with negative serology test results, according to the company. The test therefore complements results obtained by antibody serology to give a more comprehensive view of an individual’s adaptive immune response to SARS-CoV-2 infection, the company says. The test could also be used, for example, alongside serology tests to support clinical assessment of those who present with suspected COVID-19 but are PCR negative.

In the study, the T-Spot.COVID test had a positive agreement with PCR results of 96.6 percent (84/87) in SARS-CoV-2-infected individuals less than 60 days after a first PCR-positive result. At greater than 60 days (with the furthest time point after first positive PCR test result being more than 240 days), positive agreement remained high, at 83.3 percent (40/48). The T-Spot.COVID test detected substantially more people with previous positive PCR results than serology in the cohort, whose positivity rate was lower and declined faster over time.

In an endemic cohort of U.S. individuals selected to be at a relative lower risk of SARS-CoV-2 infection (based on the absence of self-reported symptoms, negative serology results, and no prior history of a positive PCR test result for SARS-CoV-2), the T-Spot.COVID test had a negative agreement of 98 percent (96/98). “We cannot exclude the possibility that a proportion of this group had, or still have, an asymptomatic infection, seronegative at the time of testing, but in whom the T-Spot.COVID test was able to detect a T cell response,” the company said in its March 4 release.

In other news, PerkinElmer on March 9 announced it had completed its previously announced acquisition of Oxford Immunotec. PerkinElmer announced on Jan. 7 its intent to acquire the company.

Agilent to acquire Resolution Bioscience

Agilent Technologies entered into a definitive agreement to acquire Resolution Bioscience. Under the terms of the agreement, Agilent will pay $550 million in cash at closing and up to an additional $145 million based on future performance milestones.

Resolution Bioscience’s noninvasive liquid biopsy assay platform supports the biopharma services market and the clinical oncology diagnostic testing market. The platform was designed for a centralized CLIA test service and a distributable kit format. The company’s homologous recombination deficiency assay received breakthrough device designation from the FDA.

Latest on COVID-19

Editor’s note: See captodayonline.com for news on SARS-CoV-2 tests (Coronavirus News). A list of FDA EUAs for COVID-19 can be found at https://j.mp/covid-19-EUA.

April 16, 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours but no more than 36 hours, between tests. This test is authorized for nonprescription use with self-collected direct anterior nares specimens from people ages 14 years and older or with adult-collected anterior NS samples from people ages two years or older.

The company also received an EUA for screening use with serial testing for its Sofia SARS Antigen FIA for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen from anterior nares swab samples from people who are suspected of COVID-19 by their health care provider within the first five days of symptom onset, or are without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two or three days—at least 24 hours but no more than 36—between tests. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate- or high-complexity or waived tests. The test is authorized for point-of-care use.

April 14, 2021–Thermo Fisher Scientific announced the FDA has expanded emergency use authorization for the Applied Biosystems TaqPath COVID-19 Combo Kit to include the high-throughput Thermo Fisher Scientific Amplitude solution.

The Amplitude solution is a molecular diagnostic testing system that aims to help clinical labs expand their testing capacity by combining the company’s extraction and real-time PCR instruments with liquid-handling products from the Tecan Group. The modular system uses a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, which received emergency use authorization in March 2020, to process samples in four steps. The platform can process up to 8,000 samples per day.

“While COVID-19 cases globally may be decreasing in some areas as vaccines become more widely available, there continues to be a demand for frequent routine testing to control future outbreaks,” Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific, said in a press release. “For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times. The Amplitude solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel.”

Testing with the Amplitude solution and the TaqPath COVID-19 combo kit is limited to CLIA-certified laboratories to perform high-complexity tests or by similarly qualified non-U.S. laboratories.

April 13, 2021—Promega Corp. released its XpressAmp Direct Amplification Reagents. The product contains components for performing extraction-free preparation of viral samples for PCR-based amplification using commonly available PCR reagents from samples collected by nasopharyngeal swab in universal or viral transport medium. The reagents allow the user to perform direct amplification analysis in RT-qPCR following a 10-minute, room-temperature incubation. With this innovation, the company says, laboratories testing for COVID-19 have a tool that enables them to skip the potentially bottlenecked RNA extraction step and move directly to PCR amplification.

Gene Herbek, MD, FCAP, was a respected pathologist at Methodist Hospital for nearly 20 years as well as a beloved husband, father, and friend. His passing in 2020 was a tremendous loss for his loved ones, patients, and colleagues.

The Women’s Methodist Hospital pathology department, Methodist Hospital, and the CAP Foundation together with Dr. Herbek’s family present the Herbek Hustle 5K Memorial Fun Run on June 19. All proceeds raised will benefit the See, Test & Treat program and the Drs. Jerry Schenken and Gene Herbek MLS Student Program Fund. We hope you’ll join us–rain or shine–in honoring and celebrating the legacy of our friend Dr. Herbek.

April 12, 2021—DiaSorin has signed a definitive merger agreement to acquire Luminex for a total equity value of about $1.8 billion.

Luminex, headquartered in Austin, Tex., develops, manufactures, and sells proprietary biological testing technologies and products throughout the diagnostics and life science industries. Through the acquisition, DiaSorin, based in Italy, will gain access to Luminex’s molecular diagnostics multiplexing technology and portfolio, including a menu of solutions in infectious diseases, respiratory infections, vector-borne diseases, hospital-acquired infections, gastroenterology infections, genetics, and women’s health, expanding DiaSorin’s presence in the United States. The acquisition will also provide DiaSorin access to Luminex’s applications in the life science industry while accelerating the availability of Luminex’s technology and solutions outside the U.S. through DiaSorin’s extensive commercial and geographical reach.

“We are really excited about this transaction, which we believe creates value for our shareholders and represents an outstanding opportunity for our future growth, positioning DiaSorin and Luminex as a unique combination of diagnostic specialists,” Carlo Rosa, CEO of DiaSorin Group, said in a press statement. “Luminex perfectly fits with our strategy to grow our positioning in the molecular diagnostics space, to broaden our presence in the U.S., and to create additional value through life science offerings.”

The transaction is expected to close within the third quarter of this year.

April 9, 2021—Hologic has signed a definitive agreement to acquire Mobidiag Oy, a privately held Finnish-French developer of molecular diagnostic tests and instrumentation, for about $795 million.

Mobidiag develops and markets PCR-based tests for acute care conditions such as gastrointestinal and respiratory infections, antimicrobial resistance management, and health-care–associated infections. The company’s Amplidiag and Novodiag automated platforms deliver turnaround times ranging from 50 minutes to two hours. The Novodiag instrument combines real-time PCR and microarray capabilities. Hologic says it intends to invest in assay development to drive growth of the Novodiag platform.

“One of our key goals is to use our strong cash flow to create a larger, faster growing company for a post-pandemic world,” Steve MacMillan, Hologic’s chair, president, and chief executive officer, said in a press release. “Mobidiag provides an exceptional new growth platform, which will generate long-term value by enabling us to enter the acute care market, which is expected to roughly double in the next five years, with a differentiated, highly competitive solution.”

Mobidiag generated approximately $42 million, or €35 million, of revenue last year. The acquisition is expected to close early in the fourth quarter of fiscal 2021.

April 8, 2021—Roche’s Elecsys EBV panel has launched in countries accepting the CE mark. The panel consists of the Elecsys EBV IgM, EBV VCA IgG, and EBV EBNA IgG immunoassays and detects antibodies specific to the Epstein-Barr virus at different stages of infection.

“The launch of the Elecsys EBV panel is an important step for the diagnosis of infections in transplant patients as it gives clear and accurate results from a single sample,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release. “The tests help to provide the information clinicians need to diagnose and treat their patients quickly, effectively reducing the need for further confirmatory testing.”

The immunoassays have excellent clinical sensitivity and specificity, the company says, and a time to result of 18 minutes. The tests require a sample volume of between 6 μL and 35 μL, depending on the assay and analyzer.

Roche will file for FDA approval in the future.