Theranos voluntarily withdraws Zika blood test from FDA approval

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theranos holmes revolution dr sanjay gupta pkg_00001721

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Story highlights

  • The company still considers Zika a "really important area of blood work"
  • Theranos cited a "positive interaction" with the FDA and said it will resubmit

(CNN)Theranos decided to voluntarily withdraw its Zika virus blood test that it had submitted for Food and Drug Administration approval, the company said Wednesday.

Theranos founder and CEO Elizabeth Holmes previously told CNN Chief Medical Correspondent Dr. Sanjay Gupta in an exclusive interview that the Zika test, though it's not one that would be as common as a test to check general health, was a priority for the company because it was a "really important area of blood work."
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She talked about the test at her first presentation to the American Association for Clinical Chemistry Meeting in August. The hope, she said, was to be able to run the Zika test on a new mini-lab device the company debuted at the conference.
    On an exclusive tour of her Silicon Valley lab in July, Holmes showed Gupta a bank of the devices being used for some of the testing that was associated with the FDA submissions.
    The FDA "cannot confirm the existence of or comment on any current/pending product applications," spokeswoman Tara Goodin wrote in a statement.
    Theranos has not revealed the reasons for their withdrawal. Applications involving clinical trial information are considered proprietary information left to companies to disclose and "not generally releasable by the FDA," explained Goodin.
    Theranos has simply confirmed that it has voluntarily withdrawn its Zika blood test, but did not perceive the withdrawal of the test as a setback.
    "In my mind, this was a positive interaction with the FDA, and I'm grateful for its collaborative approach. We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency," Dave Wurtz, vice president of regulatory, quality and clinical affairs, said in a statement.
    As of August 30, the Zika virus is circulating in 60 countries and territories. In the US, the local transmission has been seen only in Florida, where 46 cases have been confirmed.
    There are Zika tests already on the market, but multiple efforts are underway to find a test that is more easily accessible, faster and affordable. Most of the testing is currently done by state health departments.
    Testing is not currently recommended by the Centers for Disease Control and Prevention for people who do not have symptoms of the virus. In other words, if you want the test and don't have symptoms, you cannot get one.
    Theranos' general mission is to make all testing more accessible to people. Creating a Zika test fits with this mission to make "it easier for you to get the lab tests you need."
    As of now, Theranos has FDA approval for only one of its tests: a finger stick test for herpes.
    Theranos has gotten into some hot water with the FDA. In October, the FDA ruled that nanotainers the company created to collect blood were an "unapproved" medical device. The company decided to "pause" their use in all but its FDA-approved herpes test.
    In November, the Centers for Medicaid and Medicare Services started an investigation of Theranos' Newark lab and found that the company had "serious deficiencies" that put patient health and safety in "immediate jeopardy."
    On July 7, federal regulators revoked Theranos' certification for its flagship Newark lab and banned Holmes from owning or operating a medical lab for two years. The government pulled the lab's approval to receive Medicare and Medicaid payments. And Theranos had to void two years of its test results.
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    The company has been investigating its options and still provides services through its labs in Arizona.
    Theranos' Wurtz said it will continue to work on refining the company's Zika test. "We are confident in the Zika tests and will resubmit it."