We may never know with certainty, but the statistical probability of death as the direct result of an inaccurate test results delivered by Theranos is, I believe, high. Companies like Theranos, which offered little hard evidence that its tests worked to its investors, “have their own rules,” he said. Worried top international pharma expert agrees with whistleblower from Theranos blood test fraud – COVID-19 vaccine drive is following the same pattern as the Theranos scam of 2003. The U.S. Food and Drug Administration said on Tuesday it is alerting clinical laboratory staff and healthcare providers that false positive results can occur with COVID-19 antigen tests. Theranos’s test for detecting herpes simplex virus 1 is approved by the Federal Drug Administration (FDA). In 2016, Theranos invalidated two years of test results and a criminal investigation was launched into the company. But by December, the test has come under scrutiny . According to a federal indictment, Holmes and Balwani defrauded doctors and patients (1) by making false claims concerning Theranos’s ability to provide fast, reliable, and cheap blood tests and test results, and (2) by omitting information concerning the limits of and problems with Theranos… Theranos touted blood tests that were fast, painless and accurate, based on a finger-prick and a tiny amount of blood rather than larger blood draws from the arm that are common among other companies. Former Health Canada specialist in pharmaceutical regulatory assessment, Dr Saeed Qureshi , shares the fears of whistleblower, Tyler Shultz. But by summer 2017, the SEC was investigating Theranos, Holmes and … The suit claims that the test didn’t work and didn’t produce accurate results. Fake demos were presented to venture capitalists, test results from other companies’ devices were claimed to be run on Theranos’, false results were passed as … The suit was filed on behalf of an Arizona man referred to as “M.P.B.,” who purchased a Theranos test at a Theranos Wellness Center in a Walgreens in Tempe, Arizona, around December 2015. Federal health authorities banned Theranos from operating a lab in California and banned Holmes from the blood-testing industry for two years. The indictment alleges that Holmes and Balwani defrauded doctors and patients (1) by making false claims concerning Theranos’s ability to provide accurate, fast, reliable, and cheap blood tests and test results, and (2) by omitting information concerning the limits of and problems with Theranos’s technologies. Theranos had to void tens of thousands of its test results, but still managed to keep its doors open.