Theranos made the decision after the FDA said the company did not include proper patient safeguards in a study, the Wall Street Journal reported, citing people familiar with the matter.
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Elizabeth Holmes the founder of Theranos announced on August 1 a new device for blood testing known as minilab that she said had been created to be used outside of a clinical lab and could result in accurate tests from just a few droplets of blood.
The move is another setback for the Palo Alto, Calif., company as it tries to recover from crippling regulatory sanctions that followed revelations by The Wall Street Journal of shortcomings in Theranos’s technology and operations.
Theranos has told investors that it plans to collect more data and eventually resubmit its Zika application, the Journal reports. Investigations by federal prosecutors and the Securities and Exchange Commission were launched, and the company was forced to void two years’ worth of results of blood tests from its Edison machines. The miniLab is a new platform for performing diagnostic tests outside of a lab.
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. IRBs ensure that patients are treated safely and ethically during medical studies.
The controversial Silicon Valley firm, which has been sanctioned by US health regulators for failures to run its laboratories up to standard, said on Aug 1 that it had developed a test for the Zika virus and had submitted it to the US Food and Drug Administration (FDA).
The FDA’s inspection was triggered by Theranos’ request for “emergency-use authorization” to sell its new Zika test, the WSJ said.
In this case, “fast-track” entailed testing samples of blood collected in the Dominican Republic without creating a patient-safety protocol, or allowing for oversight by an institutional review board.
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“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.
