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Articles tagged with: Put It on the Board –

Put It on the Board, 4/18

April 2018—CMS changes proposed policy on NGS for cancer patients: The CAP and the Association for Molecular Pathology, in separate statements in March, lauded the Centers for Medicare and Medicaid Services for revising its national coverage determination on next-generation sequencing.

Put It on the Board, 3/18

March 2018—AMP issues recommendations for clinical CYP2C19 genotyping allele selection: To promote standardized testing across laboratories, the Association for Molecular Pathology published on Feb. 27 consensus, evidence-based recommendations for designing and validating clinical CYP2C19 assays.

Put It on the Board, 2/18

February 2018—PreludeDx unveils predictive assay for DCIS: PreludeDx announced results from its oral presentation at the San Antonio Breast Cancer Symposium. The results using the SweDCIS randomized trial confirmed that the DCIS­ion­RT test predicts which patients with ductal carcinoma in situ will benefit from radiation therapy after breast-conserving surgery.

Put It on the Board, 1/18

January 2018—Some safety issues more gray than black and white: Most laboratory safety rules are free from ambiguity. Anyone who handles specimens must wear personal protective equipment, for example. Some issues are less clearly defined, though, and require a deeper dive into the guidelines. That is where Dan Scungio, MT (ASCP), SLS, CQA(ASQ), comes in.

Put It on the Board, 12/17

December 2017—FDA announces IMPACT authorization and path for authorization of other tumor profiling tests: The FDA on Nov. 15 authorized Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The IMPACT test uses next-generation sequencing to identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a tumor.

Put It on the Board, 11/17

November 2017—Study finds biotin interference; FDA clears Flu A/B/RSV assay on Hologic’s Panther Fusion; FDA clears Abbott’s Alinity ci-series; Sysmex introduces CyFlow Antibodies for flow cytometry; Test approved for screening Zika in blood donations; New insights into female reproductive tract development

Put It on the Board, 10/17

October 2017—Houston labs learn: know the back roads: The disaster plan of the laboratories at Memorial Hermann Health System in Houston held up well in Hurricane Harvey, thanks to lessons learned in years past, but the labs have something new to add: Know in advance the back-road access routes to the various hospitals.

Put It on the Board, 9/17

September 2017—Eliminating CK-MB testing in suspected ACS: Health care leaders and clinicians should design and implement hospital-wide educational campaigns and partner with information technology and/or laboratory medicine staff at their institutions to remove CK-MB from standardized acute coronary syndrome routine order sets, say authors of a blueprint that could be a “first step to finally putting the CK-MB laboratory test to rest.”

Put It on the Board, 8/17

August 2017—AML drug approved with companion diagnostic: The Food and Drug Administration approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation. The drug is approved for use with the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

Put It on the Board, 7/17

July 2017—Putting pathology at the center of precision medicine: Michael H. Roehrl, MD, PhD, pathologist and director of the Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center, would like to see more joint development of companion diagnostics—pathologists and industry working together. It would lead, in his view, to better companion diagnostics.