Theranos, the company started by Elizabeth Holmes, isn't using its own technology for many of the tests it runs, the Wall Street Journal reports.
The $9 billion-valued company has been hailed for its development of a low-cost testing approach that only requires a tiny amount of blood and has a fast turn-around. But four former employees have told the Journal that the company only uses its Edison device for a fraction of the 240 tests it offers — one former senior employee placed it at 15 tests as of December 2014. Further, the Journal says the workers weren't confident in the results given by the platform.
In addition, according to the former senior employee, Theranos uses a special dilution method for about 60 of the tests it runs on other companies' platforms — since the company collects such small amounts of blood, it has to bring the sample volume up to what those machines require, the Journal says. For other tests, the company collects larger amounts of blood.
The Journal also reports potential irregularities in proficiency testing at Theranos. By reviewing company emails, it found that Theranos split samples sent to it for testing, running half on its Edison platform and half on machines from other companies. The two gave differing vitamin D, thyroid hormone, and prostate cancer testing results, suggesting to some workers that the Edison results weren't right, the WSJ says.
It adds that the company only sent back the non-Edison results, which it says could violate testing rules as proficiency testing samples are supposed to be handle just like patient samples, and at that time, Edison was used for such tests according to the former employees.
Some doctors have stopped sending patients for Theranos testing, the WSJ reports. In one instance, a patient with ringing in her ear went for testing, and her results showed abnormally high levels of glucose, calcium, total protein, and three liver enzymes. Her doctor, worried about a stroke, sent her to the emergency room. Tests there, the Journal notes, showed nothing abnormal.
Theranos tells the WSJ that its methods for preparing samples for analysis are trade secrets, though their methods have been disclosed to regulators. In addition, the company says it has no indication that any inaccurate results have been returned to patients and that it has disclosed that it runs "certain esoteric and less commonly ordered tests" on other machines. It adds that its lab work is accurate.