Federal inspectors showed up unannounced at $9 billion lab Theranos recently.
Feds swarmed the facilities of laboratory firm Theranos Inc. in a surprise investigation over concerns about a revolutionary new pinpick blood drawing device.
Theranos has backed off its efforts to collect tiny vials of blood drawn from finger pricks for every single test except for one, according to a Wall Street Journal report.
Theranos has blasted to the top of hot Silicon Valley startups with this method of collecting blood, making this a major setback for the company, which is based in Palo Alto, California, and is worth an estimated $9 billion.
Theranos has since gone back to acting more like a traditional lab by drawing blood from patients’ arms with regular needles. The company had aimed to totally change how blood testing is done with its finger pricks, but it’s brought the ire of the FDA, which is not yet on board.
FDA inspectors swooped in unannounced on Theranos after they became concerned with data the company submitted to the FDA as it sought to win approval for this testing method.
The FDA determine that the so-called “nanotainers” used to gather the blood was an unapproved medical device. Now, the company is only using nanotainers for FDA-cleared assays, according to the report. That would include just one of more than 100 proprietary tests — it is the one that tests for herpes.
The next step for Theranos if it wants to go back to using the nanotainers is to get them approved by the FDA.
Theranos has been widely touted as one of the hottest medical startups around, and its fingerprick technology, dubbed Edison, was one of its flagship products. However, it hasn’t quite taken off as expected, and this is certainly another blow to its efforts.
Theranos was founded in 2003 and specialized in blood tests and other medical tests. Its new blood-testing technology gets a sample with just finger prick rather than vials of blood from a typical draw via needle.