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Theranos grabs FDA approval for finger-stick herpes test

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Theranos CEO Elizabeth Holmes

Silicon Valley startup Theranos snagged FDA approval for its finger-stick test for herpes, a feather in the company's cap as it looks to expand the reach for its product and challenge its rivals' business models.

The agency based its decision on study data from 818 individuals, which showed that Theranos' finger-stick test worked just as well as a traditional blood draw in pinpointing the herpes virus in patients. The FDA blessing applies to the company's testing system, including a device, analytical software and proprietary test tubes, Theranos said in a statement.

But the company is not stopping there. With its first approval under its belt, Theranos is going to pursue regulatory clearance for its other lab-developed tests (LDTs), CEO Elizabeth Holmes told Bloomberg. Other testing companies are quick to criticize Theranos' finger-stick products, claiming the company has not published data showing its technology's efficacy. But the criticism is a "red herring," Holmes said, as the FDA hasn't required reviews for LDTs and is still in the process of updating its regulation.

"This is a really special day for our team, and it's a milestone for everything we've been working toward," Holmes told Bloomberg. "We will continue to go test by test through the clearance system."

And Theranos is charging ahead with its guns blazing. The company, which is valued at about $10 billion, lists its test prices at what it says are steep discounts to competitors, the Bloomberg article notes. Its herpes test, for example, costs about $9.07, and allows consumers to order tests without requiring insurance coverage.

The company already offers its tests at Walgreens ($WAG) stores in Arizona and California through a partnership with Walgreens Boots Alliance and will announce another state soon, Holmes told Bloomberg. Meanwhile, Theranos is hard at work on other initiatives, recently revealing a new program dubbed "Theranos MD Connect" which allows patients to conference with their primary care physicians online before and after testing.

"Our goal in providing more accessible, less expensive and less painful diagnostic tests is to enable individuals and physicians to better engage early when interventions can be most effective," Holmes said in a statement.

But Theranos could face competition from other companies developing their own testing models. Earlier this year, LabCorp ($LH) revealed that it would offer its products directly to consumers online without a doctor's order. The move comes amid increased demand for rapid at-home tests, as consumers look for quick alternatives to traditional testing.

- read Theranos' statement
- here's more from Theranos
- get the Bloomberg story

Special Reports: Top women in medical devices 2014 - Elizabeth Holmes, Theranos | Top 10 Medical Device Venture Capital Deals of 2010 - Theranos

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