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Theranos Closes Labs, Focuses On New Medical Device

Theranos Closes Labs, Focuses On New Medical Device

By: Sarah Hand, M.Sc.

Posted on: in News | Medical Device News

In a surprising turn, Theranos founder Elizabeth Holmes has announced the company will be shutting down clinical testing labs and consumer blood testing services, in order to focus on its recently-unveiled miniLab medical device. As a result of the closures, Theranos will be laying-off 340 workers across California, Pennsylvania and Arizona.

Theranos’ novel blood testing technology has been the basis of the business since the beginning, but has recently faced controversy after the company voided thousands of test results in response to concerns over the technology’s accuracy. Amidst the controversy, Holmes received a 2 year ban from owning a blood testing laboratory from the Centers for Medicare & Medicaid Services (CMS).

“We will return our undivided attention to our miniLab platform,” said Holmes in an open letter on Theranos’ website. “Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.”

The letter also refers to a new executive team at Theranos, an announcement that follows COO and President Sunny Balwani’s decision to resign earlier this year. Holmes also vows to pursue FDA approval for the new device, along with publications in peer-reviewed journals. The company has previously faced scrutiny over failing to publish data from their Edison medical device.

Their next focus – the miniLab medical device – was announced in August at the American Association for Clinical Chemistry (AACC) conference. Holmes claims the device will be able to use multiple diagnostic methods to analyze a small-volume blood sample using a single device.

“We’re pleased to share our technologies with the entire laboratory industry,” Holmes said of the miniLab device. “It’s the beginning of the next phase of the company, as we introduce our technologies to the world. We also will be working with academic institutions and other independent parties to validate and publish our results.”


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