Tag: genetic test

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 certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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August 12, 2019 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

Add eight more laboratories to the list of lab companies whose patient data were breached when the American Medical Collection Agency was hacked. According to HealthITSecurity, in recent weeks, these labs reported breaches of their patient records:

Natera
American Esoteric Labs
CBLPath
South Texas Dermatopathology
Seacoast Pathology
Arizona Dermatopathology
Laboratory of Dermatopathology ADX

MORE ON: Patient Data Breach

It

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March 18, 2019 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

Because of a $25 million grant from philanthropist Denny Sanford, the Veterans Administration and Sanford Health will provide free genetic testing to 250,000 veterans by 2022. These will be pharmacogenomic (PGx) tests designed to help VA physicians prescribe medication and dosages customized to the unique characteristics of individual patients. This innovative program was announced on Mar.

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Critical Lessons for Labs That Report PAMA Medicare Data

This is an excerpt from a 1,565-word article in the Feb.4 issue of THE DARK REPORT.
The full article is available to paid members of The Dark Intelligence Group.
CEO SUMMARY: With most hospitals now included as “applicable laboratories” in the PAMA Medicare price reporting guidelines and required to report their private payer lab test price data, this incisive

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Several Big Surprises in 2018’s Top 10 Lab Stories

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laboratories and anatomic pathology groups. What is more notable about these top

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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 reimbursement from health insurers for PGx test claims. As this testing becomes more widespread, clinical

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