Dive Brief:
- Theranos Inc. has voided or corrected less than 1% of its blood test results amid questions about its technology, a company spokesman told Bloomberg News.
- The move comes as the company faces three class action lawsuits over the technology, which claims to require only a fingerprick of blood for typical screening.
- The accuracy of those tests have come under increasing scrutiny and the company now submits individual tests to the FDA for approval, Bloomberg reports.
Dive Insight:
The relatively small change percentage clashes with the pressure Theranos faces over the technology. Theranos' value proposition is that it would change the blood-testing business through a process that required a far smaller sample and cost significantly less than a typical screen.
But CMS sent Theranos a letter in February that raised significant questions over the company's quality control and the accuracy of its tests. The letter warned that deficiencies in the Newark, CA lab posed “immediate jeopardy to patient health and safety.”
A subsequent report, released by CMS at the end of March, revealed that 29% of quality-control checks produced results that were outside of the company’s own standards. The failures included blood tests for prolactin, prostate-specific antigen (PSA) and vitamin B12. In light of those developments, the less-than-1% correction appears rather small.
Meanwhile, Theranos also must fend off the three class-action suits. Company spokeswoman Brooke Buchanan told Bloomberg the suits were without merit.