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How Many Patients Were Harmed at Theranos?

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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Theranos Ends Patient Testing, Sued for Deceiving Investors

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

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 discuss: a) her company’s new business strategy; b) an …

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Of Theranos, ADLTs, and Surgical Pathology Errors

THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry. Theranos, Inc. is a prime example of this phenomenon. Almost every month there are new disclosures about problems plaguing this high-profile lab company. As …

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Walgreens Tells Theranos: ‘Lab Deal Is Terminated’

BREAKING NEWS: As this issue of THE DARK REPORT went to press, it was learned that Walgreens had announced the termination of its lab testing agreement with Theranos, effective immediately. Theranos loses access to about 40 Walgreens pharmacies in Phoenix and is left with about five patient collection centers. The following story summarizes developments involving …

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Why Theranos Is a Big Test for CMS and CLIA

OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc., and force the lab to close? Or will it soften its …

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Up to 30,000 Theranos test results voided; Walgreen dumps partnership

This is an excerpt from a 1,000-word article in the June 13 issue of THE DARK REPORT. The original article is available to paid members of the Dark Intelligence Group.   EXECUTIVE SUMMARY: The disruptor’s plans have been thoroughly disrupted. As this issue of  THE DARK REPORT went to press, it was learned that Walgreens had announced …

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AACC reveals details of its invitation to Theranos CEO

This is an excerpt from a 925-word article in the May 23 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group.  CEO SUMMARY: In its latest lab industry scoop, THE DARK REPORT has reached out to American Association of Clinical Chemistry (AACC) leaders to find out how …

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

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 against Theranos, including revocation of the Theranos CLIA certificate. An expanded scientific advisory …

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Theranos Saga Just Keeps Getting More Intriguing

IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.

During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.

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