A powerful Congressional committee is demanding that hobbled blood diagnostics upstart Theranos describe what steps it’s taking to comply with federal law and address inaccurate test results that were provided to customers.
In a sternly-worded letter to Theranos CEO Elizabeth Holmes dated June 30, House Energy and Commerce Committee ranking member Rep. Frank Pallone and fellow Democrats Diana DeGette and Gene Green outlined the firm’s biggest recent woes, including damning lab inspections by the FDA and the Centers for Medicare and Medicaid (CMS) finding a variety of compliance issues that posed “immediate jeopardy” to patient health.
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“Given Theranos’ disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how company policies permitted systematic violations of federal law and how Theranos is working with regulators to address these failures,” wrote the members of Congress.
“We also request information to better understand the steps Theranos is taking to correct flawed test results sent to medical professional and patients,” they added. Theranos threw out two years’ worth of test results from its finger-prick Edison blood diagnostic technology over accuracy concerns, leading to a class action lawsuit by one Arizona plaintiff and the demise of once-promising collaboration with Walgreens (WBA).
The Energy and Commerce committee members requested a series of updates on how Theranos has responded to the FDA’s and CMS’ concerns, and asked Holmes both how such deficiencies occurred and what internal steps have been taken to fix them. They also asked if the companies had any plans to address the patients whose blood tests results had been thrown out and who may have received improper medical care due to the faulty tests.
Holmes has until July 14 to respond to the letter, and the company says it will cooperate with the lawmakers.
“Patient safety and clinical quality are our top priorities,” said a Theranos spokesperson in a statement emailed to Fortune. “We look forward to answering the members’ questions and explaining the significant actions we have taken with new operational leadership and quality standards at our laboratories.”
