By Ron Shinkman, Editor, Laboratory Industry Report
Theranos, the California-based laboratory startup that claims it has revolutionized testing by being able to run assays with just a few drops of blood, came under sharp scrutiny late last week by the Wall Street Journal.
Citing former employees and other sources, the newspaper reported that Theranos’ Edison platform, was only being used to perform 15 assays, as opposed to the 240 offered by the firm, and less than 10 percent of the company’s total test volume was performed on Edison.
Employees had raised concerns about Edison’s accuracy and Theranos was running tests on already commercialized platforms from Siemens and other companies. Moreover, Theranos was also collecting normal-sized specimen vials from patients who had ordered its tests, as opposed to the tiny “nanotainer” tubes it developed to collect a few drops of blood without using needles. There were also allegations that testing data on the Edison platform may have been exaggerated to the Food and Drug Administration and other regulators.
“We are disappointed to see that The Wall Street Journal still can’t get its facts straight,” Theranos said at the start of a statement issued on Oct. 16. However, the lengthy document did not refute any of the newspaper’s reporting directly, and actually repeated information contained in the article.
“As we continue with our transition to all FDA cleared or approved tests, we are now operating only under full FDA quality standards and systems. It’s the right choice and the highest standard. And as of this exact moment, that means temporarily using a different tube—tubes for venous blood—so we can maintain the quality standards we have in our labs as we complete the clearance process on the Nanotainer,” Theranos said.