February 2019

  • Digital pathology matchmaking: people, pixels

    February 2019—Digital pathology is many things. One thing it’s not is a one-night stand. As laboratories contemplate using digital pathology for primary diagnosis in the wake of the FDA’s approval nearly two years ago, it’s become abundantly clear that while digital pathology might seem to promise easy pleasure, it’s actually as complicated as keeping multiple spouses happy. Think Jacob, Rachel, and Leah. Think “Big Love.” Whatever your reference, you better (to quote the Queen of Soul) think. Think about the questions and worries of top executives. Think about pathologists and their workflow. Think about the influence of IT. And then keep thinking.

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  • HbA1c platforms studied for lipemia interference

    February 2019—A forgotten creditor. A poor relation. An envious rival. In the theater, one of these characters often emerges from the woodwork, ready to supply a plot twist just when the protagonist is riding highest.

  • Apocrine breast cancer, ESR1 mutations at center of tumor board review

    February 2019—Two breast cases—one of apocrine carcinoma and androgen receptor overexpression and another of metastatic ER-positive cancer and an ESR1 mutation—were the focus of a molecular oncology tumor board session at CAP18.

  • Conference shines light on latest in mass spec

    February 2019—Mass spectrometry has been proved to be an essential and powerful platform for clinical diagnostics. The value it adds to health care has increased steadily in the past decade.

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IN EVERY ISSUE

  • Put It on the Board

    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.

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  • Selected Pathology Abstracts
    Clinical pathology: Impact of commercial laboratory testing on a care delivery system. Read more.
    Anatomic pathology: Diagnostic algorithmic proposal based on IHC evaluation of invasive endocervical adenocarcinomas. Read more.
    Molecular pathology: Evaluation of mutational processes and somatic driver mutations in cancer exomes. Read more.

  • Q&A column

    Q. When performing a manual differential that contains immature cells, such as metamyelocytes and myelocytes, do you report an absolute count on all of the individual cells in the myelocytic line, or do you group them together and calculate one ANC? What about lymphocytes and reactive lymphocytes? Read answer.
    Q. Why and in what employment screening settings is the two-step skin test for Mycobacterium tuberculosis recommended? Read answer.

  • Click to view these CAP TODAY departments:
    President’s Desk
    Q&A column
    Newsbytes
    Put It on the Board
    Marketplace

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CAP TODAY Recommends

  • 3rd annual Diagnostic Management Team meeting

    The third annual Diagnostic Management Team meeting will be held March 5–6 at the Galveston Island Convention Center, in Galveston, Tex. The focus of the meeting is on the barriers that exist for the rapid and significant growth of diagnostic management teams to reduce medical error and optimize laboratory test use. Barriers include communication and conductivity limitations, insufficient payment for consultation services by the DMT, an inadequate number of individuals able to lead a DMT, and the cultural barriers that prevent established laboratory directors from becoming DMT leaders.

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  • Luminex offers white paper on preventing CDI

    A white paper titled “Can Global Testing for C. difficile Carriers Help to Prevent Healthcare-associated CDI?” from Luminex discusses the results of two recent studies that show that performing C. difficile testing only in patients with clinically significant diarrhea may be missing an opportunity to prevent CDI transmission from asymptomatic carriers. Download the white paper.

  • CMS national coverage decision on next-generation sequencing

    A new white paper titled “The CMS National Coverage Decision on NGS” from Diaceutics provides coverage of ongoing developments since the NGS national coverage decision was made. Read the white paper (requires free registration).

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Cytopathology

  • Cytopathology in focus: How can a lab ensure individual competence?

    January 2019—It is happening again: CAP members and cytotechnologists are asking about regulatory requirements for re-integrating into cytopathology after a period of practice latency. That is good news because it indicates that they are interested in practicing at a time when the cytopathology community can use skilled professionals. The past decade has seen a shrinking volume of Pap tests and a concomitant decline in the number of practicing cytologists, which has created new job opportunities for those with cytopathology skills.

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  • Cytopathology in focus: Serous fluid cytology and the international system

    January 2019—Just when you thought you were done implementing a new terminology for cytology, another one pops up. Is it possible there are sites that have not yet been standardized? Unbelievably, the most common nongynecologic cytology specimen, body fluids, remains a Wild West for terminology.

  • Cytopathology in focus: Three special reports capture a field in transition

    January 2019—In the September/October 2018 issue of the Journal of the American Society of Cytopathology are three special reports from the American Society of Cytopathology/American Society for Clinical Pathology workgroup on current practices and future perspectives for the field of cytotechnology.

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MARKETPLACE

  • Qiagen launches QIAcube Connect

    February 2019—Qiagen launched the QIAcube Connect, the next generation of the QIAcube instrument. QIAcube Connect fully automates the lysis, bind, wash, and elute steps of the Qiagen spin columns (which can also be used manually) for DNA, RNA, and protein sample processing. It is compatible with a range of the company’s sample technologies and can be used to automate more than 80 Qiagen kits with more than 3,000 proven protocols.

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  • National Jewish Health launches assay for NTM drug resistance

    February 2019—National Jewish Health Advanced Diagnostic Laboratories has launched a line probe assay to detect nontuberculous mycobacteria infections and identify NTM species and drug-resistance markers at a molecular level within 48 hours after obtaining a sample from culture.

  • Insight Genetics offers TNBC test

    February 2019—Insight Genetics launched its proprietary Insight TNBCtype, a test for categorizing triple-negative breast cancer tumors into distinct molecular subtypes through its wholly owned CLIA- and CAP-accredited laboratory, Insight Molecular Labs.

  • Roche’s Xofluza approved for influenza treatment

    February 2019—Roche announced that the FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease.

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