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Department of Defense
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…
Lab’s Innovation Center Encourages Staff Ideas
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and ph…
July 6, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
Did the SARS-CoV-2 virus infect people in the United States earlier than the first case diagnosed on Jan. 19, 2020? A newly-published study in Clinical Infectious Diseases, says there is evidence of COVID-19 infections in December 2019. The research team included scientists from the Nationa…
CURRENT ISSUE
Volume XXXI No. 15 – November 4, 2024
Quest and Labcorp have been targeted by class action lawsuits involving internet tracking technology. Other lab companies could be next. Also, The Dark Report examines a comprehensive report on denials and appeals of laboratory claims by payers. Finally, Labcorp and Quest show healthy Q3 earnings.
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