October 26, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – As Theranos continues to face scrutiny over its blood tests, Walgreens will hold off on expanding blood testing centers throughout its chain of stores until California-based Theranos can answer allegations about the viability of its Edison blood-testing systems, the San Francisco Business Times reported.
Citing a new report in the Wall Street Journal, the Times said the members of Walgreens Boots Alliance met with Elizabeth Holmes, Theranos’ chief executive officer, last week to discuss the issues raised by the Journal.
There are currently 41 Walgreens stores that have Theranos blood testing centers, with most of them being located in Arizona, The Verge reported. Walgreens had plans to roll out the blood centers to a large number of its 8,200 stores. However, that expansion is on hold 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.”
After the Journal’s reports, Walgreens spokesperson Markeisha Marshall told USA Today that “plans to open more Theranos Wellness Centers are dependent upon both companies’ ability to reach a mutually beneficial arrangement.”
The meeting between Holmes and Walgreens’ representatives came after Holmes continued to defend her company’s practices at a technology conference hosted by the Wall Street Journal, which is hosted on CNN Money. She said her company has never used commercially available equipment for finger-stick blood tests. Holmes has called the Journal’s allegations “factually and scientifically erroneous,” according to a statement on the company website. Theranos dismissed the allegations, saying they were “grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”
“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 its 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.Theranos has an estimated value of $9 billion.
