Theranos Disputes Report, Says Tests Are `Accurate and Reliable'

  • WSJ says small part of blood tests used own technology in 2014
  • Startup valued at $9 billion with $400 million in funding

Silicon Valley blood-testing startup Theranos Inc., responding to an article in the Wall Street Journal that questioned its technology, said its products and services are "accurate and reliable."

The Journal article said that the company overstated the ability of its tests to accurately perform several dozen types of measurements and that Theranos relied on other companies’ equipment for many tests. While the newspaper was working on the story, Theranos removed language from its website that said, "Many of our tests require only a few drops of blood," according to the article. Theranos told the newspaper it made those changes for marketing accuracy.

"Today’s Wall Street Journal story about Theranos is factually and scientifically erroneous and grounded in baseless assertions," the Palo Alto, California-based company said in a statement Thursday. The company says on its website that its blood tests use a few drops from a finger stick or "the smallest venous draw sample possible" to yield a host of lab results, from a patient’s B-cell count to her sensitivity to gluten.

In its statement, Theranos said it has voluntarily submitted all of its tests for review by the U.S. Food and Drug Administration and has 130 pre-submissions filed with the agency for tests that use its proprietary systems. The FDA cleared the company’s fingerprick test for the herpes virus in July.

Theranos’s venture-capital backers include DFJ, ATA Ventures and billionaire Larry Ellison’s Tako Ventures. The company has raised more than $400 million in funding, valuing it at $9 billion, according to the Journal. Founder and Chief Executive Officer Elizabeth Holmes, 31, has a net worth of $5 billion, according the Bloomberg Billionaires Index.

Quest, Labcorp

Theranos has sought to challenge competitors Quest Diagnostics Inc. and Laboratory Corp. of America Holdings by offering lower prices and promising quicker results. The company announced deals with insurers and health-care providers including Capital BlueCross, AmeriHealth Caritas and the Cleveland Clinic to promote Theranos blood tests. Theranos also has a partnership with Walgreens Boots Alliance Inc., the biggest drugstore chain in the U.S.

“Capital BlueCross has a strong strategic partnership with Theranos and we expect that to continue to develop and grow," said Joe Butera, a spokesman for the health insurance company. Since Capital BlueCross began a partnership with Theranos in July, “we have not heard of any customer or physician concerns about the test results," he said in an e-mail.

Amy Knapp, a spokeswoman at AmeriHealth Caritas, didn’t say whether the insurance company would stick with Theranos. The health insurer said it’s not yet using Theranos’s technology.

“We are in the initial stages of reviewing the framework to deploy our strategy," Knapp wrote in an e-mail. “We are committed to ensuring our members have access to quality health care and service and that our service providers meet regulatory requirements."

Walgreens Boots Alliance Inc.’s arrangement with Theranos spans just over 40 stores in Arizona and Palo Alto, said Michael Polzin, a spokesman for the drugstore company. He deferred to Theranos to comment on the accuracy of its tests.

Intermountain Healthcare plans to begin using Theranos’s tests in a limited pilot program, according to Daron Cowley, a spokesman for the Utah health system.

"The pilot will likely be at one clinic where traditional and Theranos testing will be done concurrently," he said. "The start date has not yet been determined, nor have other details been decided."

The Cleveland Clinic declined to comment.

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