- Theranos’ basic concept
STATES CHRONICLE – Elizabeth Holmes’ company, Theranos voids blood-test results from 2014 and 2015 and issues multiple corrected results.
Theranos Inc. has announced the federal regulators that the firm has annulled two years of results from its blood-testing devices, reports the Wall Street Journal, and is now under federal investigation.
The Edison devices were considered revolutionary back in 2014 when the company was evaluated at nine billion dollars in a funding round.
As a result of the voided blood-tests, multiple patients were given incorrect results and received erroneous, unnecessary or possibly harmful treatments.
According to some sources, in 2014, because of “abnormally elevated test results” obtained from Theranos, patients have been sent to the emergency room; in recent weeks, physicians have received corrected blood-test results.
Being Theranos’ arguably most remarkable product, the Edison blood-testing machines process around 890,000 blood tests yearly, but the 2014 – 2015’s exact number of inaccurate revised tests is still unclear.
Geoffrey Baird of the University of Washington in Seattle told the Journal that cases of massive recalls of tests in the past have occurred, but an “entirety of results form a testing platform” is unheard of.
Both Theranos Inc. and its CEO, Elizabeth Holmes became well-known thanks to the Edison machines which they say can deliver test results based on a fast and simple finger-prick of a blood sample.
Last fall, the company fell under the radar after a series of reports revealed the famous machines didn’t work, and Theranos needed to rely on generic devices to run its tests.
The federal agencies have started a criminal investigation to determine if Theranos misled its investors about the available technology.
In response to the accusations, Theranos’ spokeswoman, Brooke Buchanan, said the company has taken comprehensive measures to address the issues the Centers for Medicare and Medicaid Services has raised in its observations and that patient safety is a top priority.
The company has sent a memo of acknowledgment to its partners saying it is under investigation. Last week, Sunny Balwani, president, and board member stepped down from his role. He has been with the company since 2009.
Being once celebrated as a groundbreaking company with a mission to change the world, the company and its bright, young founder now face an uncertain and less optimistic future.
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