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 ce…
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…
August 12, 2019 Intelligence: Late Breaking Lab 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 …
July 22, 2019 Intelligence: Late Breaking Lab News
Another clinical laboratory company disclosed a major breach of its patients’ protected health information (PHI). On July 15, Clinical Pathology Laboratories (CPL), a division of Sonic Healthcare, issued a press release and disclosed that it estimated as many as 2…
March 18, 2019 Intelligence: Late Breaking Lab 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 medicat…
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 PA…
Useful Lessons for Labs That Report PAMA Data
CEO SUMMARY: Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017? One major difference is that the definition of applicable laboratories now includes most hospital labs. This creates the opportunity for a la…
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 laborator…
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…
More Primary Care Docs Will Offer Genetic Tests
CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of …
CURRENT ISSUE
Volume XXXII, No. 4 – March 10, 2025
A bold new technology has entered the European lab marketplace, with the introduction of an autonomous robotic phlebotomy device, already in service at a Netherlands hospital. Also, The Dark Report announces its sale to LabX Media Group of Ontario Canada.
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