May 2019

  • Low and inside: reducing staff turnover

    May 2019—When Monica Rocheford and colleagues at Allina Health Laboratory first began digging into rising turnover rates at various locales within the system, the effort carried a whiff of concern, if not urgency. One hospital site had jumped from a 10.8 percent turnover rate in 2016 to 44.9 percent two years later. At another site, turnover reached 49 percent in 2018, from 24 percent the year before. The culprit appeared to be a three-letter word: pay. “That was the main reason they were giving us for their resignation,” says Rocheford, system director, laboratory operations, recalling the exit interviews with departing staff. So in 2018, Allina, with nearly 1,000 lab employees (spread across 12 hospitals, a core lab, and roughly 60 clinics in Minnesota and western Wisconsin), awarded a technical increase across the board.

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  • CBD flies off shelves, fosters uncertainty in tox lab

    May 2019—If a futurist had forecast 10 years ago that, in 2019, a compound of the cannabis plant would be sold over the counter and online and consumed for health reasons by an estimated quarter of the U.S. adult population, most people would have scoffed at the suggestion.

  • IGHV gene mutation at heart of CLL treatment

    May 2019—Chronic lymphocytic leukemia is a neoplasm of small mature B-cells and the most common leukemia diagnosed in adults. Median age of diagnosis is 70 years, but there is a surprisingly large percentage of patients, about 10 percent, who are younger than 55, and it’s not uncommon now to occasionally see CLL patients, about two percent, in their 40s.

  • What UCLA learned in seven years of exome sequencing

    May 2019—Never go it alone without the input of the ordering clinician, and the diagnostic yield is better than expected. Those are two of the five lessons UCLA learned in its first seven years of clinical whole exome sequencing.

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IN EVERY ISSUE

  • Put It on the Board

    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.

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  • Selected Pathology Abstracts
    Clinical pathology: Optimization of laboratory ordering practices for CBC with differential. Read more.
    Anatomic pathology: ALK-rearranged tumors in the STUMP subcategory of uterine tumors. Read more.
    Molecular pathology: Diagnosing and targeting pancreatic cancer at the single-cell level. Read more.

  • Q&A column

    Q. Are there any FDA-approved laboratory-developed assays or point-of-care assays for detecting oxycodone or fentanyl in urine or blood? Read answer.
    Q. What was the cause of a sudden shift in values in the triglyceride assay at one clinical laboratory? Read answer.

  • Newsbytes

    May 2019—Excel tool color codes persistent  problems in lab test ordering: Variety may be the spice of life, but in the pathology lab, it may present a conundrum. Case in point: The LIS is a rich source of data about lab test utilization, but managing millions of disparate pieces of data to assess test utilization can be difficult. But not to Tylis Y. Chang, MD, of Northwell Health.

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CAP TODAY Recommends

  • Clinical laboratory test standardization key to regulatory reform

    Executives at data analytics firm Diaceutics have written an article titled “Diagnostics reform and harmonization of clinical laboratory testing” in the Journal of Molecular Diagnostics(Schreier J, et al. Epub ahead of print May 8, 2019. doi:10.1016/j.jmoldx.2019.04.002). The objective of the article is to “emphasize clinical laboratory test harmonization as an important component of legislative reform of diagnostic testing,” the authors write.

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  • Roche Tissue Diagnostics art exhibit: “Uncommon Beauty”

    The current exhibit at Roche Tissue Diagnostics’ Ventana Gallery showcases a collaboration between pathologist Marilyn Bui, MD, PhD, and her patient artist Raymond Paul. When Paul was diagnosed with sarcoma in 2011, he expressed a desire to see truly what his disease looked like. Dr. Bui invited him to view his tumor through a double-headed microscope and provided him with digital images that would become his inspiration for a series of large-scale abstract paintings.

  • Cancer Biomarkers Conference IV

    The Cancer Biomarkers Conference series provides real-world practical updates for general community pathologists, molecular pathologists, oncologists, and related specialties and professions.

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AMP Case Reports

  • AMP case report: Response to second-line osimertinib in primary EGFR p.T790M mutation

    May 2019—Non-small cell lung cancer patients with epidermal growth factor receptor activating mutations have excellent response to oral therapy with EGFR tyrosine kinase inhibitors. However, development of resistance to first- and second-generation TKIs is a well-recognized phenomenon with acquired p.T790M mutation and accounts for most TKI drug resistance. Resistance to EGFR TKI therapy has been described in tumors with coexistent primary p.T790M mutation and an EGFR activating mutation in a small number of patients. These patients with coexistent EGFR activating mutation and primary p.T790M mutation have been reported to have less than adequate clinical benefit from first- and second-generation EGFR TKI therapy.

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  • AMP case report: Acute promyelocytic leukemia with cryptic t(15;17) identified by RT-PCR

    April 2019—Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML) in which promyelocytes predominate. APL accounts for about 10 percent of AML cases, and although APL can be diagnosed at any age, it is most common among young adults with a slight male predominance.

  • AMP case report: FDA-approved DNA blood test for colorectal cancer prompts patient to undergo colonoscopy

    March 2019—Colorectal cancer is the third most diagnosed cancer and the second highest cause of cancer mortality in men and women, and in 2016 it accounted for about nine percent of all diagnosed cancers in the United States. When CRC is detected at an early localized stage, the five-year survival rate is 90 percent. With progression to regional disease, five-year survival remains high, at 71 percent.

  • AMP case report: Diagnostic pitfalls of testing rare molecular aberrations in lung adenocarcinomas

    February 2019—Lung cancer is the second most commonly diagnosed malignancy and results in the most cancer-related deaths each year in the United States, but actionable aberrations in EGFR, ALK, ROS1, and other oncogenes are improving outcomes for a subset of patients.

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MARKETPLACE

  • BD FacsDuet system gains CE-IVD certification

    May 2019—BD announced CE-IVD certification for its BD FacsDuet automated flow cytometry system. The fully automated sample preparation instrument aims to reduce errors and limit the manual user interactions required to run assays on the BD FacsLyric clinical flow cytometer.

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  • Ipatasertib combo shows promising anti-tumor activity

    May 2019—Roche presented at the American Association for Cancer Research annual meeting the initial results from a phase one-b study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer.

  • Liquid biopsy workflows for cancer research

    May 2019—Qiagen introduced its exoRNeasy Midi and Maxi kits for isolation of exosomes and other extracellular vesicles from urine and other samples and its miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples.

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