Theranos Inc. has withdrawn its request for emergency clearance of a Zika virus blood test after the FDA found that the company didn’t include proper patient safeguards in a study of the new test, according to a report in the Wall Street Journal. The move is another black eye for the California-based company, which is still reeling under heavy sanctions imposed on it because of deficiencies in its technology and operations.
On August 2, Theranos founder Elizabeth Holmes announced a new blood-testing device called miniLab that she said was designed for use outside a clinical laboratory and could run accurate tests from a few drops of blood. She also released results on the nucleic acid detection capabilities of the miniLab, and discussed its Zika-virus nucleic acid amplification-based assay. According to Holmes, Theranos had collected finger-stick blood samples from patients, including in the Dominican Republic, and run the tests on the new miniLab device, which showed that the Zika test worked. The company was seeking emergency-use clearance of the test, she said.
But during an FDA inspection, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board (IRB), according to the Journal article. IRBs ensure that patients are treated safely and ethically during medical studies.
Theranos didn’t contest the agency’s findings and withdrew its submission for authorization of the new Zika test.
FDA approval of Theranos’ miniLab would allow the company to sell the device for outside use even if Holmes is banned from owning or running a laboratory for at least two years. The Centers for Medicare and Medicaid Services imposed that ban and other penalties in July because of problems it found at a Theranos lab. The agency said the deficiencies affected test accuracy and put patients at risk.
In July, leaders of the University of Washington’s medical laboratory division balked when a Theranos manager approached the lab about working with Theranos on research, according to the Journal.
“This is a disgraced company that has not responded to the sanctions in an honorable way,” the lab’s compliance officer wrote in an email to the university technician who fielded the inquiry from Theranos. “As such, do not set up a client account for this company,” according to the email, which was reviewed by the Journal.
Source: Wall Street Journal; August 30, 2016.