FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING

By R. Lewis Dark | From the Volume XXIV No. 16 – November 20, 2017 Issue

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 …

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Achieving CLIA, ISO 15189 at Same Time with A2LA

By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue

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…

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Pathologist Raises Questions about Theranos’ Business Model

By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue

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…

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Inverness Buys Biosite, Has New Venture with P&G

By Robert Michel | From the Volume XIV No. 8 – June 4, 2007 Issue

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…

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