On Sunday, the Wall Street Journal reported that the health care startup Theranos is in trouble again because of two serious issues. The regulators for the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services are investigating two complaints.
A former employee of Theranos complained first at the month of September to the Center of Medicare and Medicaid services. The allegation was that the company instructed employees to continue blood testing patients using its devices even though there was evidence of major stability, precision, and accuracy issues. On the other hand, another allegation was filled by another previous employee in this month to the FDA and it said that a study submitted by Theranos last year for a herpes test was extremely problematic due to improper research protocols. Parts of the devices used on the tests were modified while the tests were being run, which can change the results to favor the company and it was unethical.
Furthermore, this is not the first time for Theranos that it is having trouble, even in October this blood testing startup company came under fire when the Wall Street Journal was concerned about the accuracy of the company’s test results, and after visiting Theranos’ lab the FDA also released a serious of concerns about this company.
Finally, if this blood testing startup doesn’t take those issues seriously it might fall into a black hole, and that is the biggest threat for this startup.