This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn’t welcome to provide it yet is Theranos.
The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports.
Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board.
Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety.
Zika causes problems like fever, or a rash, in most people, but an infection during pregnancy can lead to birth defects, including microcephaly, or incomplete brain development.
The blood-borne virus is typically caused by mosquito bites but also can be sexually transmitted.
Theranos is clearly eager to regain its footing in the massive blood diagnostics market and get new products out that meet the FDA’s standards.
The company is still reeling after revelations that its core technology, which promised to quickly process a full range of lab tests on a single drop of blood, was not as-advertised.
Last month, regulators banned Theranos founder Elizabeth Holmes from operating a blood testing lab. And Walgreens, Theranos’ biggest partner, severed ties with the company.
Meanwhile, competitors like Genalyte, backed by Khosla Ventures, NOWDiagnostics and Altona Diagnostics are moving ahead, apparently without running afoul of regulatory requirements.
Altona, a German company founded in 2007, sought, and won, “emergency use authorization” for its Zika-testing technology recently, and struck a business partnership that makes it nationally available via LabCorp.
Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.