Congressional Leaders Query FDA and CMS about Theranos

Earlier this summer, ranking members of U.S. House of Representatives Committee on Energy and Commerce requested a briefing from Theranos to inform the committee about Theranos' efforts to comply with CMS inspection letters and FDA 483 inspection reports. Specifically, the letter requested the briefing address changes to policies and procedures the company has made, efforts to investigate the "root cause" of compliance issues, how it identified affected patients, and how the company is helping affected providers and patients. At the same time, the Centers for Medicare & Medicaid Services (CMS) notified Theranos had not provided a "credible allegation of compliance and acceptable evidence of correction" of deficiencies found during an inspection of its Newark, Calif., laboratory. Therefore, CMS threatened sanctions that include revocation of the CLIA certificate and barring founder Holmes from owning, operating or directing a lab for two years. See "Theranos Faces More Questions and Challenges and Ramps Up Efforts to Improve Compliance," G2 Compliance Advisor, July 2016, p.1. Theranos has announced that it is appealing CMS' sanctions. The announcement also indicated that the company has made "substantial progress toward correcting the deficiencies CMS identified" and will continue to work with the agency while the appeal is pending to try to achieve a "mutually agreeable resolution to the matter."

The same ranking committee members who requested a briefing from Theranos sent letters in late July to both the U.S. Food and Drug Administration and CMS expressing, concern 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 committee members noted prior statements by Theranos about the volume of patients who were tested using its new technologies to call into question those statistics. The committee also questioned an internal investigation undertaken by the company that concluded that no patients had been harmed by the inaccurate tests.

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

To add to the company's troubles, in a lawsuit filed in Arizona last month, 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.

Meanwhile, Theranos began this month with an attempt to rehabilitate its image in the scientific community. In a widely anticipated special session at the American Society of Clinical Chemistry's 68th Annual Scientific Meeting and Clinical Lab Expo (July 31-Aug. 4, Philadelphia), Theranos CEO Elizabeth Holmes took the stage to discuss the company's technology—at least some of it. She opened by addressing the elephant in the room—government sanctions regarding Theranos' Calif. laboratory—but only to say that "we take full responsibility for our lab operations and we are working diligently to rectify all outstanding issues and to realize the highest standards of excellence in lab operations." What she really came to do, she said, was not to discuss lab operations but rather to introduce "key inventions" and "the associated science and results behind our technologies" and engage in an "exchange of scientific information about our inventions and technologies." Holmes did not address the Edison technology originally touted by the company but instead detailed the "architecture" of what the company has named the miniLab and the Theranos Virtual Analyzer (TVA), which facilitates testing across different methods in a miniature platform. The miniLab is a compact device (2.5 cubic feet) containing a mini-robot that processes single-use cartridges with the TVA remotely dictating protocols for processing. It contains a miniaturized luminometer and fluorometer, spectrophotometer and cytometer.

Holmes indicated the technology is not yet FDA approved but the company is working toward that goal. Following the presentation, AACC representatives Dr. Dennis Lo, Dr. Stephen Master, and Dr. Patricia Jones moderated a question and answer session. Dr. Master noted that the evidence Holmes presented "fell far short of" prior, very broad claims—for example, that Theranos technology could facilitate a "whole panoply of lab tests from a couple drops of blood." Holmes responded that this presentation was to begin engaging "in a scientific exchange" and discuss the architecture of one of its latest inventions. She did, however, acknowledge that "we fully understand … we have a lot of work to do to engage with this community … I wish that I had started earlier in the context of building the scientific and medical board that we've had the privilege to build and now working toward peer reviewed publications."

"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."

Takeaway: Members of Congress continue to press for details about Theranos' efforts to address deficiencies identified by the FDA and CMS. Meanwhile, the company has taken steps to increase transparency but with regard to a testing platform different than that which was the focus of their initial claims to disrupt the industry.