News and Insights from AACC Meeting in Chicago

By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue

CEO SUMMARY: There was plenty of positive energy last month when the 72nd Annual Scientific Meeting and Exhibition of the American Association of Clinical Chemistry (AACC) took place in Chicago. Attendees seemed pleased to be gathering and networking in person. However, there was re…

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Tough Times Ahead for Hospitals and Their Labs

By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue

CEO SUMMARY: These are challenging times for the nation’s hospitals, health systems, and clinical labs. A perfect storm involving unprecedented shortages of lab staff, nurses, and other professionals with inflation-fueled cost increases and deteriorating hospital finances was a major topic of…

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Congress May Soon Act on LDT, IVCT Regulation

By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue

CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…

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Congress May Soon Act on IVCT, LDT Regulation

By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue

This is an excerpt of a 2,017-word article in the November 29, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …

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Are Live Lab Industry Conferences Returning?

By R. Lewis Dark | From the Volume XXVIII, No. 12 – September 7, 2021 Issue

For several months, many of you have used conversations and email to encourage us to conduct a live Executive War College before the end of 2021. It was because of this support that we arranged a hotel in a state that has supported a return to more normal activities. Thus, our conference will …

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Theranos Lays Off More Staff, Voids More Lab Test Results

By Joseph Burns | From the Volume XXIV No. 1 – January 9, 2017 Issue

ONCE AGAIN, the controversial lab testing company, Theranos, Inc., found itself the subject of negative news stories. In recent weeks, The Wall Street Journal reported that the beleaguered lab testing company in Palo Alto, Calif., laid off 155 staffers, voided more laboratory test results, a…

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Much Disruption for Labs In 2016’s Top 10 Stories

By Robert Michel | From the Volume XXIII, No. 17 – December 19, 2016 Issue

CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…

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Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press

By Robert Michel | From the Volume XXIII No. 11 – August 15, 2016 Issue

CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…

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Score for Theranos after AACC: Fail.

By Mary Van Doren | From the Volume XXIII No. 11 – August 15, 2016 Issue

This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

By Robert Michel | From the Volume XXIII No. 7 – May 23, 2016 Issue

CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …

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