Theranos is facing another setback after they have confirmed that the blood tests submitted for approval for the Food and Drug Administration (FDA) have been withdrawn. This comes after federal inspectors found that some of the Zika data collection have been forwarded to federal regulators without the essential safeguard to prevent any harm to patients.
Theranos said that they collected finger-stick blood samples from patients in the Dominican Republic. These were then shipped to Palo Alto, California. The company now plans to resubmit the tests for approval.
Elizabeth Holmes, the chief executive of Theranos, took the stage at a major scientific conference called the American Association for Clinical Chemistry Meeting in August, CNN reported. She talked about the new technology and data for Zika testing. Sources familiar with the matter said in a statement that the Zika data from Theranos was collected without approval by an institutional review board. The institutional review board is a committee that performs a critical stopgap function in medicine as it oversees and monitors research in order to ensure that no threat is posed to patients.
Before the withdrawal of the blood tests submitted for approval for the FDA, Theranos already experienced a roadblock after Centers for Medicare and Medicaid Services is still considering the appeal of Theranos regarding the "harsh sanctions" made against the company.
One of the sanctions was that Holmes will be banned for two years to own or operate a laboratory after a number of insufficiencies were discovered at Theranos' Newark, California laboratory, The Washington Post reported.
Zika virus is now circulating in 60 countries and territories. 46 cases of Zika virus have been confirmed in the United States. Zika tests are not being recommended by the Centers for Disease Control and Prevention. They said that people who do not have symptoms but want to be tested will not be allowed to do so.
Theranos' goal is to make Zika tests more accessible and affordable to people.