FDANews
The QMN Weekly Bulletin

Theranos Rescinds Two Years’ Worth of Blood-Test Results

July 15, 2016

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics.

The company issued corrected test results to doctors and patients and also voided results for some tests. In addition to filing a plan of correction, the company has suspended further testing.

In March, CMS cited the company’s California facility for exposing patients to risk, failing to meet lab testing standards, employing unqualified staff and improperly reviewing patient test results.

In addition to CMS’s probes, the company found itself investigated by the SEC and the U.S. Attorney’s Office for the Northern District of California.

CMS’s concerns initially became public in January after the agency issued a statement of deficiencies, finding five areas where compliance standards were unmet based on a routine inspection of the California lab.

The firm responded to CMS’s concerns and suggested numerous remedial actions, which the agency deemed inadequate.

In response, CMS proposed sanctions on Theranos, including banning founder Elizabeth Holmes from the testing business for a minimum of two years and revoking the company’s CLIA certificate. The agency also focused on other officials at the firm.

Theranos President and Chief Operating Officer Sunny Balwani subsequently announced his retirement.

As Theranos’ main carrier, Walgreen’s was included in Theranos’ notification chain. In January, the retail chain halted Theranos’ laboratory services in California. The company also said it would terminate the partnership unless the company immediately complied with federal regulations.

The pioneering startup recognized for promoting massive personalized diagnostic testing, acknowledged in company records during an inspection of the California lab that the Edison machines often failed to meet the company’s accuracy standards, resulting in erroneous lab results.

According to CMS records, the lab conducts roughly 890,000 tests each year. The Edison machines were used for 12 types of tests out of 200 offered to patients. The exact number of voided tests could not be determined.

Voided test results were for calcium, estrogen and testosterone conducted with the Edison test as well as blood-coagulation tests using Siemens equipment that was programmed incorrectly.

Back in October 2015, the FDA slapped the firm with two Form 483s following an August 2015 inspection at its California facility.

Despite the findings, the company said it was preparing to open a third lab facility in Harrisburg, Pennsylvania.

Theranos has yet to release how its tests work and compare to standard blood tests.

A Theranos spokesperson responded to inquiries but refused to answer questions.

Stay up to date on regulatory stories like this one by subscribing to The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of GMPs and the Quality Systems Regulation.

View today's stories