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Problems at Theranos Described in Balwani Trial

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Former Theranos President and COO Ramesh Balwani is now being tried in federal court in San Jose, Calif. As with the earlier trial of Elizabeth Holmes, questions will arise about whether executives or clinical lab directors bear ultimate responsibility for lab test results. Balwani’s lawyers have painted him as an investor who ceded …

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Third CLIA Lab Director Testifies in Trial of Elizabeth Holmes

Laboratory Compliance / By Robert Michel

SOMETHING NEW AND UNEXPECTED SEEMS TO POP UP EACH DAY in testimony taken during the federal criminal trial of Elizabeth Holmes, founder and ex-CEO of Theranos, the defunct and discredited clinical laboratory company. Last Thursday, a third individual who served as CLIA laboratory director at Theranos was called to the witness stand. It was Lynette …

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CLIA Lab Director Testimony Shows Risks to Pathologists

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improvement Amendments multiple times. In each instance, the DOJ has presented …

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Former Theranos Lab Director Makes News at Elizabeth Holmes Trial

TDR Insider / By Robert Michel

This is an excerpt of a 1,867-word article in the October 18, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: During the trial, a pathologist who was a former Theranos lab director testified about the little regard Theranos executives had for federal proficiency …

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WSJ Reporter Tells All About Downfall of Troubled Theranos

Laboratory Management / By Joseph Burns

CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical treatments. His investigation of Theranos and its celebrated founder, Elizabeth Holmes, revealed that the company’s much-touted lab …

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How Many Patients Were Harmed at Theranos?

Laboratory Compliance / By Joseph Burns

CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the number of physicians who were worried about patient harm. After reviewing the concerns about …

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SEC Charges Theranos with ‘Massive Fraud’

Clinical Laboratory / By Joseph Burns

CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could conduct comprehensive blood tests from drops of blood collected via …

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NILA: CLIA Proposal Doesn’t Address Flaws

Laboratory Compliance / By Joseph Burns

CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive overhaul of the CLIA regulations in other areas, including …

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Theranos Ends Patient Testing, Sued for Deceiving Investors

Clinical Laboratory / By Joseph Burns

IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.” That lyric almost describes what’s happened to Theranos Inc. since October 2015. Although some would argue that Theranos brought this misfortune upon itself, …

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Score for Theranos after AACC: Fail.

TDR Insider / By Mary Van Doren

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. SKEPTICS WHO WEREN’T EXPECTING MUCH from Theranos CEO Elizabeth Holmes at the recent American Association of Clinical Chemistry’s annual meeting were proved right: Instead of delivering …

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