- Theranos has withdrawn its application to the Food and Drug Administration for emergency authorization of a test for detecting Zika virus, reports The Wall Street Journal.
- Inspectors from the FDA discovered Theranos had failed to follow patient-safety protocols in collecting data to support its case for clearance of the test, the Journal said. The new assay is designed to run on the blood-testing company's miniLab device, which founder Elizabeth Holmes unveiled at a medical conference earlier this month.
- Holmes had touted the miniLab as a way to process blood samples across a range of different tests, all in one roughly printer-size machine. As part of her presentation, Holmes pointed to its unique ability to detect Zika virus from finger-stick samples.
Theranos can't seem to stop the steady drumbeat of setbacks which have dragged down the once high-flying startup. Sanctions imposed by U.S. health regulators, which Theranos is appealing, could force the blood-testing company to change its business model and move away from clinical lab services.
The miniLabs appears to be part of Theranos' answer to that possibility. In an August 1 presentation, given in front of a packed-house of scientists attending the American Association for Clinical Chemistry's annual meeting, Holmes introduced the miniLab platform as "the beginning of the next phase of the company."
Unlike the company's troubled Edison testing device, the miniLab is designed to operate outside of a clinical laboratory. This is important because if an appeals judge upholds the federal penalties, Holmes (and Theranos itself) would be barred from operating such a laboratory for two years.
"The miniLab architecture provides a potential framework for testing in a decentralized setting, while maintaining centralized oversight," Holmes said at the AACC meeting. The device is not currently approved by the FDA.
Theranos collected finger-stick samples from individuals in the Dominican Republic, where Zika is present, to test the accuracy of the Zika assay on its miniLab device.
But Theranos collected that information without adhering to a patient-safety protocol okayed by an institutional review board, according to The Wall Street Journal, which cited individuals familiar with the matter.
The inspection by the FDA was triggered by Theranos' request for emergency authorization clearing use of the test, the Journal said.
While Theranos apparently will resubmit its application after correcting the errors flagged by the FDA, the withdrawal is not an auspicious start to Theranos new efforts.