Theranos Stops Test for Zika Following Inspection by FDA
The request by Theranos Inc for emergency clearance of a blood test for the Zika virus was withdrawn by the company after the U.S. Food and Drug Administration found that Theranos did not include patient safeguards in its study for the new test, indicated people who are familiar with the situation.
This move is yet one more setback for the company in Palo Alto, California as it attempts to recover from the regulatory sanctions that have crippled it following the revelations of the shortcomings in technology and its operations.
Elizabeth Holmes the founder of Theranos announced on August 1 a new device for blood testing known as minilab that she said had been designed to be used outside of a clinical lab and could result in accurate tests from just a few droplets of blood.
Holmes also indicated that Theranos was seeking to have its Zika test cleared. A news release said the company had collected blood sample through finger sticks from patients in the Dominican Republic and had run tests on the new device known as minilab, which showed that the test worked for the Zika virus.
However, during an FDA inspection earlier in August, regulators concluded that the company collected some data that supported accuracy of the test for Zika, without implementing protocol that was approved for patient safety according to those familiar with this situation.
The protocol calls for safety measures approved by institutional review boards to ensure that the patients are treated ethically and safely during any medical study.
It remains unclear if this problem has affected any of its patients. Some data included in its submission had been collected under approved protocols by review boards, said those involved.
Theranos did not contest the findings of the agency and withdrew submission for its authorization of the new test for Zika.
Executives at Theranos told employees of the setback last week at one of their staff meetings, said those familiar with the situation.
In a Saturday email to its investors, Theranos said plans were being worked up to collect more data that the FDA requested under protocols that are properly reviewed and to resubmit the application for approval for the test.
The approval of the new minilab by the FDA would allow the company to sell its device to be used outside even if she has been banned from running or owning a lab for the past two years.
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