Aug 2, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations, News From Dark Daily
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…)
Jun 15, 2016 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
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…)
May 16, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, News From Dark Daily
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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May 4, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)
Apr 20, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
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…)
