- Theranos CEO Elizabeth Holmes went straight to her critics on Wednesday, going onstage at WSJ Live to defend her company's practice of outsourcing tests in response to a bombshell article published by the WSJ last week. Holmes said that using other, more conventional blood test systems instead of its proprietary "Nanotainers" was an issue related to FDA methodology.
- Holmes simply refuted many of the accusations highlighted in the WSJ's reporting, including the practice of diluting tests and the company's lack of peer-reviewed papers.
- During the session, Holmes accused the WSJ of misrepresenting the facts and referred to the problem of "tabloid" journalism.
The backstory: A bombshell investigative article in the Wall Street Journal reported on allegations that Palo Alto, CA-based Theranos has misrepresented its blood testing business. According to the report, its primary testing device, known as Edison, has handled a relatively small percentage of the tests, with most testing being handled by traditional machines, such as Siemens.
Much of this was revealed by internal and former employees. Theranos is a blood testing lab which offers more than 240 tests for everything from pregnancy, to potassium levels and thyroid, to cancer and cholesterol. The initial premise of the company was that just a single finger prick of blood could yield accurate test results. So far, only one test for herpes has been approved by the FDA.
However, Holmes and her team at Theranos have fired back, providing commentary to support the accuracy of their testing methodology, as well as their ongoing interaction with the FDA in which the company seems to be moving towards approval of more tests.
According to a statement provided to BioPharma Dive from a Theranos spokesperson: "Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy."
In addition, the spokesperson spoke to the issue of the finger-stick test: "Just this past July, FDA cleared Theranos’ finger-stick test for HSV-1 using our Nanotainer tubes, which included a rigorous review of our underlying test systems and finger-stick technology.
"In order to clear that technology, FDA rigorously reviewed our test systems and Nanotainer tubes and proprietary devices. Theranos provided study data from 818 subjects of varying age and ethnicity, demonstrating that our devices could be run accurately using only a finger-stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA-cleared, commercially available reference method."
Perhaps the best part of this is that a company with a $9 billion valuation and $400 million in funding is having to confront skeptics and prove the reliability and scientific validity of its testing methodology, while also contending with more intense FDA scrutiny and working closely with the agency to gain approval for its various tests. That approval ultimately will be the best endorsement that Theranos could have and the ultimate rebuttal to its critics.