Embattled Theranos Catches a Break, Says Only 1% of Tests Have Been Voided or Corrected

Embattled Theranos Catches a Break, Says Only 1% of Tests Have Been Voided or Corrected June 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PALO ALTO, Calif. – Although Theranos voided or corrected two years’ worth of blood testing data, that only amounts to about 1 percent of tests performed by the company. Embattled Theranos has no plans to void any additional tests and did so out of an “abundance of caution,” Bloomberg reported this morning.

In May, Theranos announced it invalidated results for 2014 and 2015 and has issued “tens of thousands” of corrected blood testing results to patients and doctors. The company told federal regulators with the U.S. Center for Medicare and Medicaid Services about their decision to void the test results for the two year period. Following an initial and excoriating review of Theranos’ Newark, Calif. laboratory, Theranos said it had “voided results associated with any findings that were not consistent with the quality standards the lab holds itself to today, under our lab’s new leadership.”

Bloomberg reported Friday that Brooke Buchanan, vice president of communications, said the company does not plan to issue any more corrected blood tests and stands behind “the other 99 percent of results.” Buchanan told Bloomberg the test results were voided or corrected out of “an abundance of caution.” All patients impacted by that decision have been notified.

Even if the tests thrown out amounted to only 1 percent of all the tests conducted, the damage may have been done to the company’s reputation, which was already reeling from a series of scathing articles by the Wall Street Journal.

Bloomberg spoke with a number of Theranos customers who expressed concern over the validity of Theranos’ information. Several of the users Bloomberg spoke with said their physicians suggested they get new tests performed by another company. BioSpace reached out to Buchanan this morning to see how Theranos planned to regain consumer confidence in the wake of the voided blood tests.

As a result of the voided tests, Theranos is already facing lawsuits. Buchanan told BioSpace last month that the lawsuits were without merit and the company “will vigorously defend itself against these claims.”

In addition to dissatisfied patients, the company is also facing other legal problems. In April, the U.S. Department of Justice launched a criminal investigation into the company, with investigations centering on whether or not Theranos and its executives misled investors as to the efficacy of its blood-testing products. News of a criminal investigation comes less than a week after reports revealed that Holmes could a possible federally-mandated two-year suspension from the blood testing industry over failures to address deficiencies at lab facilities in California raised by the U.S. Center for Medicare and Medicaid Services.

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