News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device. (more…)

Theranos CEO Elizabeth Holmes Presents Scientific Data to Clinical Laboratory Chemists and Pathologists at AACC in Philadelphia

Yesterday’s presentation by Holmes was made to an audience that was clearly skeptical, and she was careful to avoid discussions about her company’s many issues and federal investigations

DATELINE: PHILADELPHIA, PA.—Yesterday, Elizabeth Holmes, CEO of Theranos, Inc., took the stage at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), the nation’s biggest clinical laboratory meeting, purportedly, for the first time ever, to deliver scientific data about her lab company’s diagnostic technologies. She also was there to answer questions from an expert panel before an attentive audience of clinical chemists and pathologists. A large number of journalists also were in attendance.

It may have escaped the notice of most of the audience—but not your intrepid editor—that the last song played over the PA system in the grand ballroom before Elizabeth Holmes was introduced and took the stage was “Sympathy for the Devil,” a big hit for The Rolling Stones in 1968. That song was an appropriate choice, since AACC’s invitation for Theranos to speak means the association is doing its own dance with the devil that some clinical chemists consider to be Theranos. (more…)

Theranos Loses Its Biggest Revenue Source as Walgreens Ends Partnership and Shuts Down Blood-Collections for Clinical Laboratory Tests

The decision means Walgreens will no longer offer Theranos blood-collection services at any of its stores, a move that is expected to cut Theranos’ income sharply because the lab testing company would no longer have a significant source of medical laboratory test volume

Walgreens Boots Alliance (NASDAQ:WBA) is ending its relationship with Theranos Inc. and closing all 40 Theranos Wellness Centers at its stores in Arizona, effective immediately, the national pharmacy chain store company announced on Sunday, June 12. It means that Theranos will no longer be able to collect medical laboratory specimens at pharmacies owned by Walgreens.

This move follows a decision by Walgreens in January that Theranos could no longer send clinical laboratory tests collected at Walgreen’s Wellness Centers to the Theranos lab in Newark, Calif. In the fall, the federal Centers for Medicare and Medicaid Services (CMS) cited the Newark lab as the source of serious deficiencies that risked patient harm, CMS said. (See Dark Daily, “CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan,” April 14, 2016.) (more…)

Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry

Honors highlight concern among public and press over potential harm to patients of the medical laboratory industry and the need for more transparency in the quality of care delivered by pathologists and lab scientists

John Carreyrou, Investigative Reporter, and Mike Siconolfi, Senior Editor, both with The Wall Street Journal (WSJ), took home the prestigious National Institute for Health Care Management (NIHCM) Foundation Journalism Award on Monday, May 2, for their work covering Theranos, Inc.

This is the third time this year Carreyrou has won the award in the General Circulation Print Journalism category for his work covering Theranos, the embattled clinical laboratory company in Palo Alto, Calif., owned by CEO Elizabeth Holmes.

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Now Theranos Faces Criminal Investigation on Whether the Clinical Laboratory Company Misled Investors, according to Published Reports

Latest news follows reports that Theranos was facing sanctions that include revoking its CLIA license and a two-year ban on its executives Holmes and Balwani and its former medical director, Dhawan

Federal prosecutors began a criminal investigation into whether Theranos misled investors about its medical laboratory technology and operations, The Wall Street Journal (WSJ) reported on Monday evening.

Investigators recently sent subpoenas to Walgreens Boots Alliance Inc. (NASDAQ: WBA) and the New York State Department of Health (NYSDOH) seeking documents and testimony about statements Theranos made, according to WSJ reporters Christopher Weaver, John Carreyrou, and Senior Editor Michael Siconolfi. As sources, the WSJ cited unnamed people familiar with the matter. (more…)

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