More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test

Published: Sep 01, 2016

More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test August 31, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PALO ALTO, Calif. – Embattled Theranos has run into another testing snag. This time with its proposed blood test for the Zika virus. The company was forced to withdraw its request for emergency clearance of the test after inspectors with the U.S. Food and Drug Administration found the company did not include proper patient protections in its study, according to the Wall Street Journal.

The withdrawal is another setback for the company that is facing crippling sanctions from the U.S. Centers for Medicare and Medicaid Services that are threatening to shut down one of its laboratories, as well as prevent founder and chief executive officer Elizabeth Holmes from operating a laboratory for two years. Theranos is appealing that decision. Last week the company said it was making “substantial progress toward correcting the deficiencies CMS identified.”

During a presentation at the American Association for Clinical Chemistry on Aug. 1 Holmes showed off the company’s new portable laboratory system, dubbed Edison, which is expected to be able to run a multitude of diagnostic tests, including detection of the Zika virus. During the presentation to the association, Holmes said the company had collected numerous finger-stick samples from subjects where the Zika virus is prevalent, including in the Dominican Republic.

However, when inspectors from the FDA looked into the testing methods, they discovered Theranos had “collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board,” the Wall Street Journal said. Such reviews are used to determine patients are treated both safely and ethically during studies. Following that revelation, the company withdrew its request. The FDA’s inspection was prompted after Theranos requested “emergency use authorization” to sell the Zika test, the Journal reported.

Zika has certainly been a hot news item this summer, as areas across the globe, such as Brazil and even in Miami, have suffered from the mosquito-borne virus. The Zika virus is a mosquito-borne disease that causes mild flu-like symptoms in most people. In pregnant women, it may be linked to an increased rate of microencephaly, a neurodevelopmental disorder characterized by a smaller-than-normal head and brain size. Life expectancy for individuals with microencephaly is reduced and the prognosis for normal brain function is poor. The virus may also be linked to an uncommon autoimmune disorder of the nervous system called Guillain-Barré syndrome.

The World Health Organization declared Zika virus an international public health emergency. Currently there is no available vaccine for the Zika virus, but some companies such as Vaxart, are racing to develop a vaccine.

Dave Wurz, vice president of regulatory and clinical affairs at Theranos, told the Journal that he hoped the company’s decision to voluntarily withdraw the Zika testing submission is “further evidence of our commitment to engage positively with the agency.”

Citing “people familiar with the matter,” the Journal said it remains unclear if there were any patient issues during the collecting of blood samples.

Theranos plans to collect additional data as requested by the FDA under “properly reviewed protocols and resubmit the Zika application,” the Journal noted. In addition to Zika data, the Journal reported that Theranos intends to submit clearance for an Ebola test as well.

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