Report: Theranos Lab Didn't Live Up to Its Own Accuracy Standards
Released by the CMS (Centers for Medicare and Medicaid Services) agency and seen in unredacted form by the Wall Street Journal, the data confirms that the company knew its finger pin-prick tests were often wrong when it used them in October, 2014. It has since pulled most of the testing done by its key "Edison" machine and can only perform a single herpes test. However, the FDA and CMS received complaints from Theranos employees that even that one was "tainted by breaches in research protocol."
A Theranos spokesman told Engadget that "we've made mistakes in the past in the Newark, California lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures." It says it has since added new "quality systems, policies and procedures," changed personnel and voided results from its Newark lab, where most of the problems were found.
However, Weill Cornell associate professor of pathology Stephen Master told the WSJ that "based on [the new] data, it's hard for me to believe that they went live with this instrument and tested patient specimens on it."
Of the 13 tests cited by the CMS, one incorrectly measured PSA antigens used to detect prostate cancer 22 percent of the time, while a testosterone level test was incorrect at a rate of 87 percent. Overall, the quality check results were outside of Theranos' own standards 29 percent of the time, according to the report. The CMS document also details how Theranos failed to inform patients of erroneous results in a timely manner, incorrectly stored blood samples and produced widely different results from traditional testing methods.
Because of all that, the agency accused Theranos of endangering patients and gave it 10 days to come up with a corrective plan in January. It has yet to accept Theranos' proposal to correct its procedures, and may fine the company or strip it of its human testing certification. All of that may be moot, however, as its main source for customers, Walgreens, has reportedly pulled its support.