As Congress Asks Theranos for Documentation, Its CEO Zigs to A Whole New Platform

Its business plan and technology under fire, Theranos appears to be playing metaphorical three-card monte with federal lawmakers and the laboratory community curious as to whether it will become a more transparent enterprise.

Members of the U.S. House of Representatives’ Committee on Energy and Commerce have been pressing the California-based laboratory to produce a variety of answers regarding how it plans to correct a multitude of defects in testing platforms and associated medical devices.

Theranos has been under fire for the better part of a year, as The Wall Street Journal began reporting serious issues with the company’s Edison testing platform, which it had claimed could perform hundreds of tests with just a few drops of blood. It has since spiraled into federal investigations, fines, and a potential barring of Chief Executive Officer Elizabeth Holmes from operating a laboratory for two years.

In a July 26 letter to the U.S. Food and Drug Administration (FDA), three ranking members of the Energy and Commerce Committee—Frank Pallone Jr, Gene Green and Diana DeGette—said they were concerned about the number of tests Theranos had invalidated that had been performed on its platform. Theranos had said in June approximately 70,000 tests—slightly less than 1 percent of 7 million performed— had been invalidated.

But the letter quoted a statement issued by Theranos saying that at least 57 percent of patients using its test services had undergone finger-stick testing and by December of 2014, “‘more than 80 tests on Theranos’ online test menu were offered via finger-stick and performed using proprietary technologies.’” The committee also questioned an internal investigation undertaken by the company that concluded that no patients had been harmed by the inaccurate tests.

This follows a letter sent to the company directly in June that requested a briefing to inform the committee about Theranos’ efforts to comply with CMS inspection letters and FDA 483 inspection reports. See “Democratic Committee Leaders and CMS Present Latest Challenges to Theranos,” National Intelligence Report, 7/14/16, p. 4.

A lawsuit filed in Arizona last month by a Theranos patient claimed he suffered a heart attack less than a month after undergoing routine lipid and A1C testing that showed no abnormalities, leading his doctor to make no changes to his medication or lifestyle. The test results were later invalidated by the company.

“It is unclear whether the corrected blood-test reports Theranos has issued thus far capture the universe of inaccurate blood test results that the company has provided patients,” the House letter to the FDA said.

Meanwhile, after Theranos founder and Chief Executive Officer Elizabeth Holmes promised for months she would provide data detailing the practicality of her company’s testing platform at the American Association of Clinical Chemistry’s annual meeting earlier this month, she chose to provide another platform instead.

That would be a food processor-sized device called a miniLab that would theoretically be able to perform hundreds of tests. It contains a miniaturized luminometer and fluorometer, spectrophotometer and cytometer. The movement of fluids is performed by a miniaturized robotic arm. All analytes and reagents are stored within disposable cartridges that are inserted into a slot in the front of the platform.

Data can be transmitted remotely to full clinical labs for further analysis. Holmes suggested that a remote site—say in a developing country—would use many such devices for test processing, with full-scale labs in the U.S. and elsewhere drilling down to provide deeper analysis.

Holmes said trials have shown that tests can be performed accurately with as little as two microliters of blood. Testing for potassium, lipids and the Zika virus have shown to be within national standards, according to Holmes. However, she conceded that the figures presented were not assay validation data—the kind that would allow the FDA to eventually approve the platform for full-scale use. “What we wanted to do today is introduce the invention and multiple methods of testing,” Holmes told the audience.

There was no lack of skepticism from conference attendees. One was curious that the potassium testing was through normal venous samples and not through Theranos’ nanotainer collection device, which was touted as a primary component of both Theranos’ faulty Edison platform and the miniLab. Holmes said the sample collection occurred in a regular hospital setting, and that the acuity of the patients had to be taken under consideration when gathering samples.

“The architecture of Theranos’ technologies, and the associated science and technology are sound, as was demonstrated ... at the AACC Scientific Meeting,” said Susan A. Evans, a member of Theranos’ Scientific and Medical Advisory Board, in a statement released not long after Holmes presentation concluded. “Innovations like this are very exciting. The Theranos miniLab ... has the potential to increase access and bring laboratory testing to the patient, whether close to home or in remote locations that are currently underserved.”

At the conference, Holmes very briefly acknowledged her company’s difficulties at the start of her remarks: “We take full responsibility for our lab operations and we’re working diligently to rectify all outstanding issues and to realize the highest standards of excellence in lab operations,” she said.

Takeaway: Theranos continues to face skepticism despite initial efforts to be more transparent about its technology.