- Testing startup stands by tests, doesn’t plan more corrections
- All patients affected have been notified, company says
Less than 1 percent of the blood test results Theranos Inc. has provided have either been voided or corrected, according to the company, which last month said it was canceling or altering tens of thousands of results, including two years of results on some of the company’s proprietary machines.
The revisions were made out of what spokeswoman Brooke Buchanan said was an abundance of caution. In response to questions from Bloomberg, the Silicon Valley startup said it has informed all patients who were affected.
Yet some patients say they’re not sure whether to trust the remaining medical results provided by the startup, whether they’ve been notified of problems with their tests or not.
Jani Penttinen, 40, who runs a language translation technology startup, got a letter from closely-held Theranos saying that some of his test results were voided.
“This report contains corrected results,” announced red letters of the top of each page. Of the 70 results, two had been voided -- and both of the wrong tests had shown abnormal results, including a vitamin B12 deficiency for which his doctor recommended supplements.
“This result should not be used out of an abundance of caution,” the report said beneath each voided test. “Redraw is recommended as clinically indicated.” The entrepreneur took vitamin B12 supplements for a few weeks, though says he wasn’t harmed medically.
Review Them All
Even though his report said the majority of his results were accurate, Penttinen said in a telephone interview that it’s hard for him to have faith at this point.
“I feel I need to review all those tests.”
Colin Jordan, who works in public relations in the San Francisco area, got two blood tests through the company last year for a blood panel and an allergy test, and hasn’t heard from Theranos that any of his tests were wrong. Still, his doctor recommended he get his blood work redone elsewhere as a precaution.
“It’s such a big question mark, I’m not going to leave it to chance,” he said in a telephone interview.
Loss of patient trust would be another damaging blow to the once high-flying startup, which promised to revolutionize the blood-testing industry -- dominated by Quest Diagnostics Inc. and Laboratory Corp of America Holdings -- with cheap, less-painful tests that used only a finger-prick of blood and could be run on what the company has said are its breakthrough analyzers. In recent months, as Theranos has faced questions over whether its technology worked, it has said that it stopped using its own devices and is submitting individual tests for FDA approval. Three class action lawsuits have been filed against the company, claiming consumer fraud and false advertising.
“The lawsuits filed against Theranos are without merit and the company will vigorously defend itself against these claims,” Buchanan said in a statement.
Denise Terry, who is CEO of her own health startup, EmbraceFamily Health, said she’s had about half a dozen routine blood tests through the company in Silicon Valley. She said her doctors continued to send her for Theranos tests even as questions about the company arose. She said she hasn’t heard from the company about whether she was impacted by the corrections.
“Are they going to mail me a letter? Are they going to e-mail me? Overall I am very disappointed,” she said. She said she is now using another lab for tests.
Not to Standards
The decision to void some results was made because previous tests weren’t up to the standards of Theranos’s current lab managers, Buchanan said.
Theranos has yet to present peer-reviewed studies showing that its technology works, though it has said it will present some data at the American Association for Clinical Chemistry’s annual meeting, which starts on July 31. But it may be too little, too late, says John Ioannidis, a professor of medicine at Stanford University who has been critical of Theranos.
“The mere fact that they retracted all these thousands of tests, this is extremely uncommon, and in a way it already proves that what they’ve been doing has failed,” he said. “The question is, has it failed forever or is there some still glimpse of hope that it could work?”
Theranos doesn’t plan to send more corrections, and stands behind the other 99 percent of results, said Buchanan.
Regulators have had doubts about the company for some time. In January, the Centers for Medicare and Medicaid Services sent Theranos a scathing letter detailing deficiencies at its Newark, California lab that the department said was putting patients’ health and safety in “immediate jeopardy.”
Soon after, Theranos told the agency that there was “no evidence of systemic errors” at its lab and that “no patient impact is expected.” In March, the agency said the company hadn’t backed up those claims and threatened fines and potentially sanctioning company executives from working in the industry for as long as two years. The U.S. hasn’t leveled any sanctions at this point, and Theranos’s tests are still being offered.