It’s been a big month for Theranos, the $US9-billion blood testing startup.
In its second big FDA announcement this month, Theranos received clearance to administer its herpes blood test outside a traditional lab setting, which it says will go toward the company’s goals of making the technology and the information it provides accessible to more people.
Earlier this month, the FDA approved the herpes blood test, which its makers say can test for disease with just a finger-prick’s-worth of blood. That was the first test approved for the Palo Alto, California-based startup headed by CEO Elizabeth Holmes.
In this latest step, the FDA granted Theranos a Clinical Laboratory Improvement Amendments Waiver, which means the company doesn’t have to use the same type of labs as standard tests that are a more lengthy process with a needle and multiple vials of blood. Instead, you can simply walk into a pharmacy, get pricked, and check your results online.
Theranos claims its fingerprick testing is just as accurate as drawing blood from a vein, but costs significantly less. “We want to be the highest-quality, lowest-cost lab service, period,” Holmes told Bloomberg earlier this month.
Now, the test can be used at Theranos “wellness centres,” where the samples are collected and tested. Several centres have already cropped up in Arizona, California, and Pennsylvania, and Theranos plans to expand to other locations.
The company says it’s just getting started: It has more than 120 other tests for diseases such as hepatitis and Ebola down the line which it wants to gain FDA approval.
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