Theranos Continues to Battle Wall Street Journal Critics, Says FDA Made Unannounced Inspections
October 22, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK -- Elizabeth Holmes, chief executive officer of Theranos, continued her ground campaign to refute a scathing Wall Street Journal report alleging the company only performs 10 percent of its blood tests on its proprietary technology.
At a Wednesday technology conference hosted by the Wall Street Journal, which is hosted on CNN Money, Holmes continued to defend Theranos’ practices. She said her company has never used commercially available equipment for finger-stick blood tests.
After the Journal’s report was released, Theranos and Holmes fired back, calling the article technology “factually and scientifically erroneous,” according to a statement on the company website.
“Every finger-stick test that we have ever done, uses proprietary Theranos technology that is not commercially available,” Holmes said at about the two-minute mark in the CNN video.
Holmes added that her company is only collecting finger-stick tests for the herpes virus for which it has received regulatory approval. In July, the FDA approved Theranos’ systems and test for herpes simplex 1 virus. The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger. Holmes added that Theranos “voluntarily” sought FDA approval, which is why it isn't yet using its technology for most blood tests.
Holmes said the FDA conducted an unannounced inspection of Theranos’ labs in July and that their systems were cleared by the regulatory agency at the end of that month, Bloomberg reported. Additionally, Holmes said the FDA conducted a second inspection in August to check “compliance with quality systems regulations.” She reiterated that the company is only using its proprietary Nanotainer technology to test for herpes, which is the only procedure for which it has FDA approval. She said the company is in the process of seeking FDA approval to use its own technology to perform other types of testing.
Holmes, the world’s youngest self-made billionaire at 31 years of age, said her company was started with a mission of helping individuals find out more about their health through finger-stick blood tests. She said most people find out about illnesses when it’s too late.
In its article, the Journal alleged the company only preforms 10 percent of its blood tests with the company’s proprietary technology and opts to perform the majority of its blood tests using technology acquired from other companies, including Siemens . In the article the Journal cited several former Theranos employees, as well as the medical records of patients who had used the Theranos blood test. According to the article, the former employees allege the company split testing between its own proprietary Edison machines and technology acquired from other companies. The use of the two separate technologies yielded different results “when testing for vitamin D, two thyroid hormones and prostate cancer.”
“The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings,” the Wall Street Journal said in its article. “After the lab employees showed the results to president and chief operating officer Sunny Balwani, Balwani ordered them to stop using Theranos-built machines for the test, and only report the results from external machines to the government.”
Theranos dismissed the allegations, saying they were “grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”
“The sources relied on in the article today were never in a position to understand Theranos’ technology and know nothing about the processes currently employed by the company. We are disappointed that, in an effort to make its story more dramatic, this reporter relied only on the views of four ‘anonymous’ disgruntled former employees, competitors and their allies, instead of reaching out to many of the scientific, health care and business leaders who have actually seen, tested, used and examined our breakthrough technologies,” Theranos said in its earlier response to the Wall Street Journal.