Theranos withdrew its request to gain emergency-use authorization from the FDA for its Zika blood test, according to the Wall Street Journal. An FDA inspection earlier this month found that the company did not have proper patient safety protocols in place during a study of the test.
At the 68th American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo from July 31 to Aug. 4, Theranos CEO Elizabeth Holmes showcased the new miniLab platform that allows for the processing of small capillary whole blood and plasma samples outside of a clinical laboratory. At the Expo, Ms. Holmes also discussed the company's Zika nucleic acid-amplification-based assay. The assay can be run on the miniLab platform.
The company collected blood samples from subjects, including in the Dominican Republic, and ran them on the miniLab. The study showed that its Zika test worked. However, an FDA inspection conducted in August showed that the company failed to implement a "patient-safety protocol approved by an institutional review board," when collecting some of the data for the study, according to the WSJ.
Currently, no patient safety issues have been reported. The company did not challenge the FDA's findings and withdrew its application. Theranos told investors that it "recognized" that "some patient data was collected before the review-board protocols were in place," the WSJ reports.
Theranos is, however, appealing sanctions placed by CMS on its Newark, Calif., lab. CMS banned Ms. Holmes from owning or operating a medical lab for at least two years, among other sanctions. These sanctions came after a November 2015 inspection by CMS showed a number of infractions at the lab.
In addition, the FDA declared Theranos' nanotainer, a capillary blood collection device, an "uncleared medical device," in a 2015 inspection, noted the WSJ report. The nanotainer was one of the devices used to collect blood samples when studying the Zika test.