When it comes to tests, they normally come at a cost. Not just when it comes to the money but also the process the tests require, with most requiring something from you. Theranos came to the public light earlier in the year saying that its Edison device could carry out over 200 medical tests with a few drops of blood from a finger prick. Now it would seem that leaked documents raise more than a few concerns with the results of the tests not being as accurate as first reported.
The latest revelation comes as federal regulators release a redacted version of an inspection report that covers 121-pages showing some discrepancies with that the company reported and what they actually had achieved. In 2015, the Edison was used to test for testosterone levels and resulted in failure 87 percent of the time when it came to quality control. A similar test to detect prostate cancer failed 22 percent of the time and tests for the hormone prolactin failed 47 percent of the time.
Even internal standards set by the company failed to be met time and time again, with a test for Vitamin D in any given blood sample requiring to be within 20 percent of the results given by the traditionally used machine. On none different and randomly selected blood samples the difference ranged anywhere from 21 percent to a whopping 130 percent difference in Vitamin D levels.
The report doesn’t just argue with the results, it also argues with how the tests were conducted. With test results differing from standard lab devices and even unqualified employees running some of the tests, people have begun to raise more than a few questions regarding the Edison and even the companies viability, with the Centers for Medicare and Medicaid Services (CMS) stating that while Theranos have got a plan in place, they were unsatisfied with the plan and would impose sanctions that include fines and retraction of the companies approval to test human samples.
