TAG:

pharmacogenetics

Vanderbilt Lab Uses Predictive Medicine to Improve Care

> CEO SUMMARY: The integrative diagnostics lab at the Vanderbilt University Medical Center aims to use sophisticated diagnostics to advance the use of precision medicine testing to improve patient care and to do so at an affordable cost. As part of these efforts, the lab staff …

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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What Comes Next for the Pathology Profession?

IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target…

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

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Concerns Raised Over Pharmacogenetic Tests

CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…

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April 8, 2019 Intelligence: Late Breaking Lab News

BeaconLBS announced a collaboration with MagnaCare of Garden City, N.Y., last month. The press release issued by the two companies stated that MagnaCare would use the “BeaconLBS Physician Decision Support (PDS) solution with its network of physician and laboratory…

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February 25, 2019 Intelligence: Late Breaking Lab News

Quest Diagnostics sold its clinical laboratory business in India last December, thus ending a 12-year effort to build a thriving business in that nation of 1.3 billion people. The buyer was Strand Life Sciences of Bengaluru, India. The transaction was announced in a…

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February 4, 2019 Intelligence: Late Breaking Lab News

More than 63 healthcare and medical service organizations signed a letter asking officials at the federal Centers for Medicare and Medicaid Services (CMS) to reconsider their latest interpretation of a National Coverage Determination (NCD) on the subject of next-generation sequencin…

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U of Florida Health Improves Patient Care with PGx Testing

CEO SUMMARY: Since 2011, the University of Florida Health System has used pharmacogenetic test (PGx) results to guide physicians when they prescribe certain drugs. This initiative has improved patient outcomes, reduced the overall cost per episode of care, and gained partial reimbursemen…

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Under Audit, Labs Need Statistics on Their Side

CEO SUMMARY: When commercial and government payers use auditors to review a lab’s claims, they often use statistical sampling and extrapolation to limit the time needed to review claims. But proper sampling and extrapolation require following the rigorous scientific methods to produce a…

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