Theranos, the $US9 billion startup that wants to revolutionise blood tests, issued a detailed rebuttal on its website to the Wall Street Journal Thursday morning.
The rebuttal is a response to an explosive story published in the Journal last week.
The Journal’s report alleged that Theranos is struggling to make its ‘revolutionary’ in-house technology actually work, and reports that only about 10% of Theranos’ blood tests use its technology, with the rest of the tests being carried out using traditional blood-testing tech. Even the company’s own employees have concerns about Theranos’ blood tests.
Theranos, whose goal is to make clinical testing cheaper and faster, issued a point-by-point rebuttal to the Journal’s story. The company touches on its interactions with the FDA, the accuracy of Theranos’ tests, and the fact that only a fraction of its tests are performed with finger-sticks.
Here are some of the points Theranos makes in its rebuttal:
- It’s no secret that only some of Theranos’ tests are finger-stick tests, as opposed to venous draws. “We have consistently said in public statements, on our website, and to our customers in Wellness Centres that some of our tests are performed on venous draws, in part because we have been becoming a full-service laboratory,” Theranos says in its statement.
- Theranos stands by the fact that its blood tests are accurate. The company writes: “With each FDA filing, Theranos is showing that our finger-stick tests are just as accurate as venous draws, starting with our first FDA clearance this summer.”
- Theranos says its proficiency-testing protocols are complicit with regulations — and the company has initiated conversations with the FDA. “Theranos has explained our process to our regulators, and proficiency testing at Theranos meets the regulatory requirements,” Theranos says.
Since the Journal’s story last week, Theranos’ accuracy has come into question by some people who have taken its tests, including ex-Apple exec Jean-Louise Gassee.
In its rebuttal, Theranos also tries to call into question the sourcing used by John Carreyrou, the Pulitzer Prize-winning reporter who wrote the story, by calling attention to the fact that he used anonymous sourcing in his story. From a journalistic perspective, anonymous sourcing is often helpful, if not necessary, to get access to sources (often employees or former employees) who otherwise wouldn’t speak out of fear of violating non-disclosure agreements or retribution from the company they’re speaking out against.
“From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story,” Theranos says in its post. “The articles that appeared last week are the inevitable product of that approach.”
The Journal released a statement on Wednesday after Theranos founder Elizabeth Holmes spoke at the WSJ’s Digital conference. “We note that Ms. Holmes sought to challenge the reliability of our sources, but it remains the fact that she doesn’t know from whom the information for our articles was gathered,” the Journal said in its statement. “We assure her and our readers that our sources were well positioned to know the information they provided about Theranos, and they were vetted before publication.”