Moscow. January 28. Laboratory biotech startup Theranos, which has managed to attract in 2014, $9 billion, did not comply with several of the clinical standards of the United States. And one of the violations is so serious that poses a risk to the health and wellbeing of patients, to such conclusion the American regulators.
The biggest concern of the inspectors has caused a hematological test, which identifies components of blood, including red and white blood cells and platelets.
The text test results Theranos, who brought his 31-year-old founder Elizabeth Holmes is the title of the youngest female billionaire, on Wednesday unveiled the American media. Newspaper the Wall Street Journal, announced the coming publication, wrote that the Holmes company may exclude from Medicare (health insurance program in the U.S. that pays for treatment of people over 65 and disabled), if it doesn’t fix the violations.
It Theranos is given 10 days, otherwise the laboratory in Northern California, which passed the test, will lose their licenses, writes The New York Times. Company Holmes has already responded to the claims of the authorities, promising for several days to eliminate the shortcomings. In a statement Theranos emphasizes that 90% of their tests conducted in the laboratory in Alabama that are not affected by verification.
The founder of a startup Theranos Elizabeth Holmes Photo: Reuters
Elizabeth Holmes founded a company Theranos in 2003. After in 2014, she managed to attract investors from $9 billion, she was considered a rising star in Silicon valley, and is often compared with the head of Apple Steve jobs. Holmes claimed to have created a new method of blood analysis, which need only a drop of blood taken from a finger and not numerous vials of venous blood. Theranos has promised to make a breakthrough in the early diagnosis of diseases, because the tests are cheap, quick and effective.
But the delight of the press died down a little after October last year, the newspaper the Wall Street Journal wrote that the company’s Elizabeth Holmes gives incorrect and incomplete data about their work to clients and investors. To such conclusions came after a newspaper investigation that took several months.
It turned out that the unique technology of the analysis of blood Theranos under the name “Edison”, which requires only a drop of blood from the finger of a patient was used in only 15 tests at stated in the advertisement 200. All other tests were conducted using conventional technologies, in particular, on the equipment of Siemens. In this case samples had to be diluted to obtain the desired volume of liquid.
In addition, often the results obtained by using the patented technology, does not coincide with the results of the analyses carried out in the traditional way, the newspaper wrote citing former employees of a startup.
Now the only test which the company performs on-equipment “Edison” is the analysis on herpes, and approved the FDA food and drug administration (FDA).
Forbes by the end of 2015 have included Holmes in the top ten worst CEO as the company has not demonstrated to the market impressive results.