Top News

July 2018

  • Allison_Kimberly_Featured

    Small groups, big answers in HER2 testing

    July 2018—Take the new ASCO/CAP guideline for HER2 testing. Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. The previous guidelines turned out to be tough acts to follow—a bit like following Sean Connery in the role of James Bond—even as the new one benefits from new data.

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  • Dr. Anthony

    Look, wait, buy: labs share instrument plans

    July 2018—“Robbie,” the autonomous service robot that transfers specimens for Florida Hospital’s central laboratory, may not quite be ready for his gold watch. But after five years of faithful service delivering samples between the different esoteric testing units, he’s nearing the end of his natural lifespan with signs of wear.

  • Dr. Mathews

    With CMS coverage policy, NGS cancer testing goes large

    July 2018—The March 16 announcement of a new Centers for Medicare and Medicaid Services coverage policy for next-​generation-sequencing–based diagnostic lab tests for patients with advanced cancer did not appear out of the blue, since a draft policy was issued last fall.

  • Dr. Singh

    Artificial intelligence: what’s possible, why now?

    July 2018—When it comes to artificial intell­igence, it can be difficult to distinguish hyperbole from reality. So how much can AI truly replace human tasks in society and, more specifically, in medicine?

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JULY DEPARTMENTS

  • Put It on the Board

    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.

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  • Clinical pathology selected abstracts

    Trends in perioperative RBC transfusion from index cases in five surgical specialties
    July 2018—In recent years, greater attention has been given to patient blood management. While contemporary national guidelines recommend restrictive red blood cell transfusion, it is not known whether such transfusions have decreased in surgical patients. Approximately 11 million RBC transfusions are performed annually, and two-thirds of those are for patients in the perioperative period.

  • Q&A column

    July 2018—Is CD30 currently being used as a predictive marker for therapy? Due to laboratory construction, our molecular instruments were relocated within the lab. Is full test validation required in this case? Or is running at least 20 known samples enough to verify the instrument/assay performance specifications?

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

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CAP TODAY Recommends

  • Cancer Biomarkers Conference III

    Houston Methodist Department of Pathology and Genomic Medicine is presenting its Cancer Biomarkers Conference III, Sept. 15–16, at the Houston Methodist Research Institute. More than 20 speakers will cover topics such as updates on PD-L1 testing for lung cancer, urologic cancers, and melanoma, the current approach to using cytology specimens for biomarker testing, the oncologist’s approach to TKI therapy, and many more. The conference’s educational objectives include distinguishing the proper collection, management, and submission of pathology specimens for cancer …

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  • 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).

  • 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

  • Milan_FeaturedImage2

    Cytopathology in Focus: Reporting salivary gland cytopathology—new user-friendly Milan system consists of six diagnostic categories

    May 2018—The Milan System for Reporting Salivary Gland Cytopathology was published Jan. 31 and is an important step toward standardizing the reporting of salivary gland fine needle aspiration. A large body of literature has demonstrated that FNA is an effective method for the initial evaluation of salivary gland masses, but until this year there was no uniform, widely accepted reporting system. The complexity of salivary gland cytology poses unique challenges that demand a standardized approach to communication of diagnostic information between pathologists and treating clinicians.

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  • Cytopathology in Focus: For thyroid cytopathology, the 2017 Bethesda System

    May 2018—Surgical pathologists take their tumor nomenclature from the WHO Classification of Tumours, but cytopathologists take their terminology from where the consensus groups convened—Bethesda, Paris, Milan, and Yokohama—to formulate terminology recommendations. The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC)1 is now in its second edition.

  • Modified Giemsa stain. Highly cellular smear showing fibroadenoma with mix of small and large hyperplastic ductal epithelial cell tissue fragments and large myxoid stromal fragments. High-power image shows myoepithelial nuclei on the epithelial fragments and in the background as bare bipolar nuclei. Inset: Modified Giemsa. Fragment of benign breast tissue consisting of ductal epithelial cells with interspersed myoepithelial cells.

    Cytopathology in Focus: Standardized reporting for breast FNAB cytology

    January 2018—In countries with developed medical infrastructure, the use of breast fine-needle aspiration biopsy (FNAB) cytology has had its share of challenges over the past 20 years, among them the use of core needle biopsies. In developing countries where the use of FNAB cytology has been increasing rapidly, breast lesions are one of the most common sites sampled by FNAB. In 2016, the International Academy of Cytology Executive Council put together a “Breast Group,” which consists of cytopathologists, surgical pathologists, radiologists, surgeons, and oncologists working in breast care, with the aim of producing a comprehensive and standardized approach to breast FNAB cytology reporting.

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MARKETPLACE

  • 538-ArlingtonSci

    FDA clears ASI Evolution

    July 2018—Arlington Scientific announced it has received FDA 510(k) clearance for its ASI Evolution, a fully automated nontreponemal syphilis system for diagnostic testing and blood donor screening.

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  • CARB-X awards Specific Diagnostics $1.7 million

    July 2018—CARB-X has awarded Specific Diagnostics up to $1.7 million to support the development of the company’s antibiotic susceptibility testing system. Up to $1.7 million more could be awarded based on achievement of project milestones. Specific’s AST instrument determines phenotypic antibiotic susceptibility within hours of blood infection.

  • Cancer Genetics modifies TOO test

    July 2018—Cancer Genetics announced it has received special 510(k) clearance from the FDA for its Tissue of Origin test following modifications made to test reagents and software.

  • 537-BioRad

    Liquichek AMH Control

    July 2018—Bio-Rad Laboratories has launched its Liquichek AMH Control for reproductive health testing.

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