November 2018

  • Time now for tumor mutational burden?

    November 2018—Like a piece of so-called sticky music, cutoff numbers can persist in physicians’ minds outside of any real clinical value and, in the process, leave their laboratory colleagues mildly befuddled (not to mention searching for more useful cutoffs). Such a jingle is creeping into tumor mutational burden. Lauren Ritterhouse, MD, PhD, co-director of the clinical genomics laboratory at the University of Chicago, recalls early conversations about TMB at her institution. Amid discussions about how and when to implement the testing, one colleague announced to all assembled that the cutoff number should be 100.

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  • New momentum for harmonizing lab results

    November 2018—In The Music Man, the four members of the local school board, notorious for their squabbling, are assigned to investigate the credentials of “professor” Harold Hill, a charming con man who has come to town to sell band uniforms and instruments.

  • Biotin interference: answering questions, reducing the risk

    November 2018—Biotin use is not rare, and don’t count on it being listed in the patient’s electronic medical record. Those are some of the findings of a Mayo Clinic study published recently in Clinical Biochemistry.

  • Component IgE testing offers food for thought

    November 2018—Food component testing offers improved specificity for distinguishing IgE sensitized from truly allergic patients, and the menu for allergen components may soon expand.

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IN EVERY ISSUE

  • Put It on the Board

    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.

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  • Selected Pathology Abstracts
    Clinical pathology: Preparing for passage of regulatory requirements for laboratory-developed tests. Read more.
    Anatomic pathology: HER2: a pan-cancer event highly enriched in AR-driven breast tumors. Read more.
    Molecular pathology: Common genetic variants contribute to risk of rare severe neurodevelopmental disorders. Read more.

  • Q&A column

    Q. Is anticoagulant adjustment in citrate tubes necessary when a patient’s hematocrit is less than 20 percent? Read answer.
    Q. What is the substitute test for HbA1c for a patient with homozygous variant hemoglobin? Is a fructosamine and/or glycated albumin test appropriate? Read answer.

  • Newsbytes

    How Henry Ford core lab uses bottom-up communication
    November 2018—When Henry Ford Health System started planning its core laboratory’s automation line four years ago, aware that it needed to take Lean to the next level, it enlisted frontline laboratory employees in a development process that used the strategies of Hoshin Kanri and kaizen. Read more.

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CAP TODAY Recommends

  • 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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  • VIDEO SERIES: The future of the lab in health care

    In a collaborative effort to discuss the future of the laboratory in health care, Bob McGonnagle, publisher of CAP TODAY, gathered with Orchard Software’s Curt Johnson, chief operating officer, and Matt Modleski, chief operating officer, American Health Network. This roundtable was edited into a series of seven short videos.

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Cytopathology

  • Cytopathology in Focus: Synergy in cytopathology and molecular microbiology

    August 2018—In today’s less-is-more world, health care consumers and providers often seek explicit and detailed information from minimally invasive procedures and tiny samples. Over are the days of “malignant cells present” and on to the next case. Cytopathologists and cytotechnologists are embracing and integrating novel techniques and applying new methods to the diagnosis and classification of essentially every imaginable form of neoplasia. The 2018 WHO publications confirm that 29 percent of deaths worldwide (more than 10 million people annually) are attributable to communicable diseases.1,2 This means the purpose of procuring many specimens is not to just rule out malignancy but also to diagnose infectious etiologies.

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  • Cytopathology in Focus: Why not call everything ASCUS?

    August 2018—Below is a question shared on the ASC listserv. My reply to the question follows. A pathologist colleague who practiced previously as an obstetrician/gynecologist is of the opinion that categorizing the level of abnormality we observe on a Pap test is a waste of time. All the clinician needs to know, he says, is whether the test is normal or abnormal. The Pap test is a screening test, he says correctly, and its only relevance is in pointing out who needs a colposcopy and biopsy.

  • Cytopathology in Focus: Cytology social media—Facebook and Twitter as networking tools

    August 2018—If you are not already using social media professionally, you may not know there is a vibrant and active community of pathologists, including many cytopathologists, on Facebook and Twitter—and getting involved is easy, fun, and educational.

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MARKETPLACE

  • Qiagen partners with DiaSorin, NeuMoDx

    November 2018—Qiagen has introduced an automated, CE-marked workflow for its Quanti-Feron-TB Gold Plus Blood Collection Tubes and a novel DiaSorin Liaison Test on DiaSorin’s Liaison systems. The launch offers Liaison customers high-throughput detection with QFT-Plus as part of the system’s broad menu, and QFT-Plus users will gain an option for full automation of laboratory handling to support TB control efforts. Customers using the new latent TB detection workflow for Liaison systems will purchase the detec-tion components from DiaSorin and the blood collection tube kits from Qiagen. The test is available in Europe and other markets, with an expected U.S. release in 2019 and in China in 2020. In a separate release, Qiagen and NeuMoDx Molecular announced a strategic partnership to commercialize two fully integrated systems for automation of PCR test-ing. Under the agreement, Qiagen will initially distribute the NeuMoDx 288 (for high throughput) and NeuMoDx 96 (for mid-throughput) in Europe and other markets outside of the United States; NeuMoDx will cover the U.S.

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  • Henry Ford Health partners with Sakura Finetek

    November 2018—Detroit-based Henry Ford Health System Pathology and Laboratory Medicine announced a research and development partnership with Sakura Finetek USA to increase the automation level of its core anatomic pathology laboratories.

  • Beckman joins forces with Johns Hopkins

    November 2018—Beckman Coulter Diagnostics is collaborating with Johns Hopkins Medicine to explore co-innovation initiatives with the goal of developing and commercializing novel solutions that address challenges in health care.

  • Qiagen, Hamilton Robotics collaborate

    November 2018—Qiagen and Hamilton Robotics announced a collaboration to improve processing of Qiagen’s QuantiFeron-TB Gold Plus diagnostic test through the integration of Hamilton’s Microlab Star automated liquid handling workstation into the QFT-Plus assay workflow.

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