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Theranos Blood Test Temporary Halted By FDA Inquiry

Blood Test Vial

The needle-free blood test startup that vowed to revolutionize medical testing, Theranos, indicated in a Friday statement that its trademark blood sampling practice which samples via finger pricks has been brought to a temporarily halt in light of questions raised by the U.S. Food and Drug Administration (FDA).

The Silicon Valley based company, which was founded by the 31-year-old Stanford dropout Elizabeth Holmes, is under scrutiny by regulators over its nanotainer. The nanotainer, according to the FDA, requires regulatory approval as a medical device. As a result, the company has stopped using the device while it awaits FDA approval of its nanotainer, the Wall Street Journal reports.

David Boies, an outside lawyer representing the company, was quoted by the NY Times as having said that the issue at hand “is not an issue relating to the reliability of the tests that are being performed,” as the company has received no indication regarding any problems with the test’s accuracy — this after more than three million tests having been administered.

The issue here is not an issue relating to the reliability of the tests that are being performed (…) We haven’t had any indication about a problem of the accuracy of the test, and we’ve done more than three million tests.

While Theranos and its self-made billionaire founder address their regulatory concerns, WIRED‘s Nick Stockton reports that the company is by no means the only one looking to disrupt the healthcare industry with needle-free blood tests. For instance, DNA Medical Institute in Cambridge, Massachusetts has its own process which begins with a finger prick that draws roughly 5-10 microliters of blood, which is then inserted into the company’s “rHEALTH” machine. The machine mixes nanostrips with reactive chemicals and then beams a laser through the sample in order to determine what’s going on with the blood based on the spectral output created by the nanostrips.

ForbesMatthew Herper reported that Holmes needs to “stop complaining” and answer the “important questions” raised regarding her company’s diagnostic.

What do you think, is it time for Holmes to step up to the plate and respond to inquiries?

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