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Put It on the Board

FDA clears 2 of 3 ePlex blood culture ID panels:
January 2019—GenMark Diagnostics announced in December that it received FDA market clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels. GenMark’s third panel, ePlex Blood Culture Identification Gram-Negative (BCID-GN), was submitted to the FDA in September 2018 and is still under review. The fungal pathogens panel has broad coverage and includes many resistant and emerging strains, among them Candida auris, GenMark said in its statement. The company says that by coupling BCID panels with the ePlex Templated Comments software module, hospitals can enable immediate intervention linked to a diagnostic result and improve the effectiveness of antimicrobial stewardship initiatives.

12 assays for Atellica Solution:
Siemens Healthineers achieved 12 pre-market approvals from the FDA for its Atellica Solution infectious disease and oncology testing menu.

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Newsbytes

January 2019—Virtual tumor board platforms: a game changer for cancer case review: If Suneal Jannapurredy, MD, had been able to read the patient’s outside radiology report prior to breast tumor board, he would have re-examined the gross specimen to determine whether, as the other providers were now telling him, there was a second area of focus he hadn’t included in his presentation.

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Molecular pathology selected abstracts

Editors: Donna E. Hansel, MD, PhD, chief, Division of Anatomic Pathology, and professor, Department of Pathology, University of California, San Diego; James Solomon, MD, PhD, resident, Department of Pathology, UCSD; Richard Wong, MD, PhD, molecular pathology fellow, Department of Pathology, UCSD; and Sounak Gupta, MBBS, PhD, molecular pathology fellow, Memorial Sloan Kettering Cancer Center, New York. Development of brain circuits ...

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Put It on the Board

Pathologists and population health—
first steps

December 2018—Pathologists and population health—first steps: Pathologists who want to become involved in population health initiatives can take five main steps, say pathologists and laboratory leaders interviewed for an article published online last month in Archives of Pathology & Laboratory Medicine. In “The role of the pathologist in population health,” the authors report on the interviews they conducted and their review of the literature to answer several questions, among them whether pathologists in both large settings and smaller community-based settings can engage in population health (yes), and whether pathologists are in a position to analyze data for population health (“The data are there,” they say, “but getting to the data—and providing meaning out of it—is the hard part”). One of the first steps to becoming involved in any type of population health management activities, the authors write, is to understand the philosophy of the institution’s CEO and senior management.

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Q&A column

Q. Can you explain further the revised CAP checklist requirement COM.40850 “LDT and Class I ASR Reporting,” which says to describe the method and performance characteristics in test reports unless the information is available to the clinician in an equivalent format? Read answer. Q. Can we see reactive lymphocytes in the pediatric population (under age two), and can we report them? Read answer.

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Newsbytes

In molecular testing labs, gaps between actual and desirable LIS capabilities
December 2018—Flashback to 2013: Alexis B. Carter, MD, then director of pathology informatics at Emory University Hospital, was contemplating whether other pathology labs nationwide were facing the same challenges managing molecular testing data as she and her colleagues. So she decided to find out. Dr. Carter conducted a survey, and the responses confirmed her suspicions: Most laboratory information systems fall short in providing the infrastructure for complex molecular and genomic testing.

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