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Tag Archives: Put It on the Board —

Put It on the Board, 9/16

September 2016—AMP lays out clinical utility standard for molecular Dx: The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

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Put It on the Board, 8/16

August 2016—LabCorp will acquire Sequenom; New York ends state PT services; St. Jude lands CAP ISO 15189 accreditation; Epigenomics’ DNA test included in CRC guideline; OSU to deploy Inspirata digital pathology solution; Mindray’s clinical chemistry analyzer cleared; Successful Keytruda trial stopped early; Top court clarifies autopsy’s place in Texas law; EUA for Siemens Zika assay

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Put It on the Board, 7/16

July 2016—Michel: The good, bad, and ugly that labs need to know: Robert Michel’s opening remarks at the Executive War College, which can be seen as a kind of state of the union address for laboratory medicine, focused on the trends in the industry and the opportunities and dangers they create. “Fraud and abuse. That’s the ugly,” Michel began. “Folks who are doing lab medicine the right way aren’t really aware of what’s been happening outside the walls of their laboratories.”

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Put It on the Board, 6/16

June 2016—Guidance seen as sign of FDA openness to digital pathology, Eco effort cuts biohazard waste, saves money, EGFR mutation liquid biopsy OK’d as companion Dx, Qiagen adds Horizon QC to next-generation system, Siemens enters molecular oncology services market, Roche PD-L1 tabbed as complementary test

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Put It on the Board, 4/16

April 2016—Logistics hurdles overcome for single Pap-HPV report: Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

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Put It on the Board, 3/16

March 2016—Case raises uncertainty on autopsy’s legal status: Should a hospital-provided autopsy be considered health care? It’s a question the Supreme Court of Texas will decide this spring, and its answer to that question will make a big difference—in the millions of dollars—to the claimants, Christus Health Gulf Coast v. Carswell. It could also have an impact on the medical liability coverage available to pathologists who perform autopsies in the Lone Star State.

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Put It on the Board, 1/16

January 2016—2016 may be year of action on laboratory-developed tests: During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

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