October 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – Theranos and its chief, Elizabeth Holmes, called a scathing Wall Street Journal report alleging the company only performs 10 percent of its blood tests on its proprietary technology “factually and scientifically erroneous,” according to a statement on the company website.
Theranos said it provided all the necessary information to the Wall Street Journal to “prove the accuracy and reliability of its tests and to directly refute these false allegations, including through over 1,000 pages of statements and documents.”
“Disappointingly, the Journal chose to publish this article without even mentioning the facts Theranos shared that disproved the many falsehoods in the article,” Theranos said in its statement.
Holmes, the world’s youngest female billionaire, and her company, Palo Alto-based Theranos are under fire after 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.”
Other issues of splitting the testing methods included accuracy problems with the testing of potassium levels in the blood.
“Some of the potassium results at Theranos were so high that patients would have to be dead for the results to be correct, a former employee told the Wall Street Journal.
Theranos dismissed the allegations, saying they were “grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.” Theranos said the report also failed to take into account recent developments made in the company’s Edison technology.
“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.
Additionally, the company said its Edison testing product has “proven accurate and reliable for tens of thousands of satisfied customers through millions of tests and experiences and in ongoing review by our various regulators.”
In July, Theranos received clearance by the U.S. Food and Drug Administration for its test system and test for herpes simplex 1 virus IgG. Theranos said the FDA’s decision “provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run.”
The Journal’s article said much of Theranos’ testing in 2014 did not have to be made public. Privately-held Theranos, which has a value of $9 billion, said it has followed all necessary guidelines and opened itself up to regulators “like no lab before and voluntarily submitting all our tests for FDA review, the gold-standard for quality.”
