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Tuesday, Apr 19 2016

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Justice Department, SEC Launch Probes Into Theranos' Practices And Technology

The investigations, revealed in a letter from the company to its outside partners, are just the latest setback for the blood-testing startup.

Theranos, the embattled blood-testing laboratory, said on Monday that federal officials were conducting a criminal investigation into the company, adding to a series of questions from officials about its inner workings. In a note to outside partners, the company said that the Justice Department had requested documents and that the investigation was active. The note also said that the Securities and Exchange Commission was investigating the company. (Abelson and Pollack, 4/18)

"The investigations by the SEC and the U.S. Attorney's Office, which began following the publication of certain news articles, are focused on requesting documents and ongoing," the statement read. "The company continues to work closely with regulators and is cooperating fully with all investigations." (della Cava, 4/18)

People familiar with the matter said the subpoenas seek broad information about how Theranos described its technologies and the progress it was making developing those technologies. Investigators are also examining whether Theranos misled government officials, which can be a crime under federal law, some of the people said. Such subpoenas don鈥檛 necessarily mean prosecutors are actively seeking an indictment. People familiar with the matter said the investigation is at an early stage. (Weaver, Carreyrou and Siconolfi, 4/18)

The criminal and civil investigations are among several probes described in a company memo provided to Bloomberg on Monday by closely held Theranos. The memo was sent to Theranos鈥檚 鈥減artners,鈥 which include Walgreens Boots Alliance Inc. and others. 鈥淭he company continues to work closely with regulators and is cooperating fully with all investigations,鈥 Theranos said. It has also been probed by the Food and Drug Administration, the Centers for Medicare and Medicaid Services, or CMS, and state health departments in Pennsylvania and California. Theranos said the FDA and state inquiries are closed. (Kohlhatkar and Chen, 4/18)

Elizabeth Holmes, CEO of the embattled blood-testing company Theranos, has tried more than a few approaches in recent months to head off the waves of bad news that just keep coming. She鈥檚 gone to bat for her company at an industry conference, posted a 6,000-word defense on its website, and this month assembled a group of respected medical advisors. On Monday morning, Holmes tried a new tack: an appearance on NBC鈥檚 鈥淭oday鈥 show. (Robbins, 4/18)

In what is sure to be a hot ticket this summer, Elizabeth Holmes is going to present data on Theranos鈥 technology at a meeting of scientists well-equipped to judge its validity. The American Association for Clinical Chemistry said today that Holmes will speak at a plenary session of its annual meeting in Philadelphia on Aug. 1. Theranos spokeswoman Brooke Buchanan confirmed the presentation, saying, 鈥淲e鈥檙e really excited about the opportunity to share our technology with the world.鈥 (Brooks, 4/18)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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