Theranos recalls tens of thousands of tests: 7 things to know

Palo Alto, Calif.-based Theranos, a $9 billion startup known for its micro-sample blood tests, is retracting two years of test results performed on its proprietary "Edison" devices and is issuing corrections, The Wall Street Journal reported.

The move is a dramatic one as the company works to turn around its reputation. Theranos fell from grace after a pair of investigative reports ran in The Wall Street Journal alleging the company overstated the capabilities of its Edison devices. Since then, the FDA has prohibited Theranos from using Edison for all but one test. It has faced a federal inspection and a criminal investigation. CMS has threatened to ban founder Elizabeth Holmes from operating labs for two years, as well as to revoke the lab's license and impose fines. The startup lost a $350 million deal with Safeway, reduced its board by more than half and recently lost its president and COO, Sunny Balwani.

Here are seven things to know about Theranos' step on the road to redemption.

1. A person familiar with the matter told WSJ the company voided Edison test results from 2014 and 2015. It has issued tens of thousands of corrected test results that include both voided Edison results and revised results from tests run on traditional lab devices, according to the report.

2. No exact figure for the number of tests voided or corrected was provided. The company's Newark, Calif., lab ran approximately 890,000each year, according to reports from a CMS inspection cited by WSJ. The company has said its proprietary device was used for 12 out of the more than 200 tests it offered, according to the report.

3. Physician practices confirmed they received corrections. Voided tests included those for calcium, estrogen and testosterone, according to the report. Some of the incorrect test results led patients to seek emergency treatment, according to the report.

4. The company also issued corrections for some tests performed on traditional machines. These include blood-coagulation tests performed in the Arizona lab, which was not under investigation, according to the report. Those tests were performed on Siemens AG equipment that a person familiar with the matter told WSJ was programmed to the wrong setting.

5. Walgreens, which hosts 40 Theranos clinics in its Arizona drugstores, declined to comment. However, it was informed by Theranos about the corrections, according to the report. The partnership has been on thin ice due to the challenges the lab has faced, and Walgreens has said it will terminate their agreement if Theranos cannot turn around its operations.

6. Theranos issued the corrections as part of its efforts to address issues CMS found in its inspection. "Excellence in quality and patient safety is our top priority and we've taken comprehensive corrective measures to address the issues CMS raised in their observations. As these matters are currently under review, we have no further comment at this time," Theranos spokeswoman Brooke Buchanan told WSJ in a statement.

7. The startup is preparing to open a third lab. A person familiar with the matter told WSJ it is opening another lab in Harrisburg, Pa., indicating the company sees a future beyond its current challenges.

 

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