Theranos Corrects Tens of Thousands of Blood Tests

The Wall Street Journal reported last night that the company has told its regulator, the Centers for Medicare & Medicaid Services, that it has voided tens of thousands -- two years worth -- of patient blood test results. The tests were run on both the company's proprietary Edison machines and conventional testing equipment, the paper said. Some results were thrown out and some revised.

The Journal, which owns this story in a big way, cited its usual source: "a person familiar with the matter." Forcing Theranos to issue its usual confirmation, plus this statement:

"Excellence in quality and patient safety is our top priority and we’ve taken comprehensive corrective measures to address the issues CMS raised in their observations," Theranos spokesperson Brooke Buchanan said in an email to KQED. "As these matters are currently under review, we have no further comment at this time."

If you've been following this story -- which has unfolded like some sort of Silicon Valley morality tale -- you know that Theranos made a splash with investors and the media by claiming it was going to remake the diagnostic testing industry with more efficient and cheaper blood tests. The company said it could sample just a finger-prick's worth of blood, collected in a device it called a "nanotainer;" that small amount of blood, the company claimed, was enough to run a host of tests. The FDA, however, approved the process for just one of those tests, and the company collects samples for all others the traditional way -- from a patient's vein.

In March, The Wall Street Journal reported Theranos had run tests measuring blood-clotting time on 81 patients despite erratic results from quality-control checks. Around the time the story came out, Theranos released a statement saying it had contacted any patients potentially affected by inaccurate tests.

“We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health," said Theranos’ Newark, California lab director, Dr. Kingshuk Das, in a statement.

Apparently, Theranos has expanded that group of patients. From the Journal:

[The corrections mean] some patients received erroneous results that might have thrown off health decisions made with their doctors. ...

Several physician practices in the Phoenix area confirmed receiving corrected test reports from Theranos in recent weeks. ...

There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle. “I believe that’s unprecedented.”

One Phoenix-area physician received a corrected report for a patient who was unnecessarily sent to the ER based on the original test results, the paper said.

These revised or voided tests may or may not satisfy CMS, which has been weighing whether to drop the hammer on Theranos since March, when the agency informed the company it had not submitted credible evidence of correcting serious deficiencies at its Newark, California lab. Those deficiencies, which CMS had uncovered during an inspection, were potentially life-threatening to patients, CMS said.

Among the penalties CMS threatened: revoking the lab's federal license to operate and suspending Theranos founder and CEO Elizabeth Holmes from involvement in the blood-testing industry for two years. CMS also named president and COO Sunny Balwani as subject to suspension, but Balwani last week announced his departure from the company.

At the same time it informed Theranos of potential penalties, CMS gave the company one last chance to submit additional proof of its compliance with regulations. Theranos responsed to CMS with additional information, and there's been no word from CMS since that story broke in April.

If CMS declines to accept Theranos' filing as valid proof of compliance, the company will still have options for administrative appeal. So it's possible the final resolution of the case may not come for months.

But even if Theranos manages to avoid sanctions from CMS, it still faces investigations by both the SEC and  the U.S. Attorney’s Office for the Northern District of California. It also faces what many assume will be the end of its high-profile deal with the Walgreens Boots Alliance, which put dozens of Theranos "Wellness Centers" in Walgreens stores in Arizona, giving the secretive company and its unproven technology a needed dose of credibility.

That has now been wiped out by the one-two punch of the Journal's investigative reports and the failed federal inspection. Last October, the Journal reported allegations by Theranos employees that the company may have violated reporting rules related to proficiency tests run on Edison.

Theranos' Buchanan says federal regulators have issued no findings related to allegations of cheating on proficiency testing or manipulating data. The struggling company recently added a group of doctors and medical scientists to its advisory board to comb through data and help Theranos publish its results publicly.