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Theranos faces congressional inquiry over faulty blood tests

TechCrunch TechCrunch 5/07/2016 Sarah Buhr

The U.S. House of Representatives recently sent a letter to troubled blood analysis startup Theranos asking for an explanation of the company’s failure to offer accurate results to patients using its proprietary blood test technology.

Theranos developed a technique using its proprietary ‘Edison’ machine it claimed could detect hundreds of diseases using just one drop of blood. However, government and regulatory agencies have questioned those results and the company now faces an onslaught of class-action lawsuits from patients.

The company has also suffered a dramatic plummet in valuation, had to void two years worth of blood test results, founder Elizabeth Holmes was threatened with a possible ousting from her own company and a potential barring from the industry, as well as faces a potential criminal investigation, and Theranos main partner Walgreens recently pulled out.

House Democrats Frank Pallone, Gene Green and Diana DeGette sent the letter, dated June 30, asking founder Elizabeth Holmes to explain what went wrong, what steps her company is taking to help medical professionals and patients who might have been affected by the results and how Theranos plans to comply with regulators.

“Given Theranos’ disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how company policies permitted systemic violations of federal law,” reads the letter.

Theranos says it looks forward to clearing things up for these lawmakers. “Patient safety and clinical quality are our top priorities,” Theranos said in a statement. It also said it was, “committed to the highest standards of excellence across all our labs.”

“Patient safety and clinical quality are our top priorities,” Theranos said in a statement. It also said it was, “committed to the highest standards of excellence across all our labs.”

Theranos has continued to say it plans to reveal information about its technology. And Holmes is scheduled to speak at the American Association of Clinical Chemistry (AACC) conference on August 1st. However, House Democrats are asking for a response from Theranos by July 14.

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