TAG:
clia waive
FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING
CEO SUMMARY: Market clearance of the first-ever CLIA waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer …
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
Pathologist Raises Questions about Theranos’ Business Model
Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…
Inverness Buys Biosite, Has New Venture with P&G
CEO SUMMARY: On the same day that Inverness Medical Innovations announced that it would acquire Biosite, thus beating out Beckman Coulter in the bidding war for Biosite, Inverness also announced that it had entered into a joint venture with Procter & Gamble. Together, the two companie…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.