Startup medical company Theranos is voluntarily limiting its latest blood testing technology to only one out of every 200 tests offered by the company because of reports that the company has overstated the accuracy of its tests.
The company’s CEO Elizabeth Holmes made the announcement during an interview.
Theranos once said that it could perform accurate tests using only a few drops of blood using its latest technologies, but now the company is starting to backtrack on this claim.
Theranos needs approval from the FDA before its latest technology can be used more frequently. Until that occurs, the company has started voluntarily limiting its offerings of finger-sticking tests that only need “a few drops of blood”.
The company has been criticized by the media for reportedly overstating the accuracy of its technology. They say that the claim made by Theranos that it only required “a few drops of blood” was not accurate.
However, Theranos has defended its practices and its claims. That being said, the company did remove of the claim of only needing “a few drops of blood” from its website.
Reports also indicate that the FDA has been examining the practices of Theranos more closely following the reports by the media.
The startup currently has a valuation of about $10 billion, and it has major partners in the healthcare industry.
Theranos says that it is doing everything it can to be compliant with standards mandated by the FDA. The company is reportedly using traditional vein draws for blood sampling, which requires more blood than the company’s new finger-sticking tests.
Their latest technology requiring less blood is reportedly only being used for one type of test.
Additionally, many tests that are being conducted in labs ran by Theranos are not making use of devices produced by Theranos.
CEO Holmes said, “We do two things, we have the Theranos system, our proprietary devices, and then we use conventional, FDA-cleared devices that are used in accordance with the manufacturers’ instructions to run the test.”
Right now, Theranos has 130 tests that need clearance from the FDA before they are allowed to be practiced. The company says that it will transition these tests to finger-sticking technology that requires a smaller amount of blood than traditional vein draws on a case by case basis.
Holmes is confident that the blood tests offered by Theranos can eventually all make this transition.
She says, “Every time you do something innovative, people want to knock you down because they built you up. They say it’s crazy, it could never be done, and eventually you change the world.”
However, the company will first need approval from the FDA. Until then, its testing technology will remain limited.