TAG:
genetic testing kits
Our Top Ten Lab Stories Highlight Major Changes
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
Genetic Testing Genie Is Now Out of the Bottle
CEO SUMMARY: There’s been an uneasy standoff between companies that want to sell genetic tests directly to consumers over the Internet and both state and federal regulators. But now it appears that the FDA is ready to take off the gloves and assert greater control over genetic …
CURRENT ISSUE
Volume XXVII No. 9 – June 22, 2020
THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.
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