Theranos Inc. was accused in a lawsuit of misleading consumers about the accuracy of its blood test results and reliability of its technology.
The suit is the latest setback for the startup since the Wall Street Journal last year raised questions about its test results. The U.S. Securities and Exchange Commission, federal prosecutors in San Francisco, and federal and state health regulators are investigating the company.
“Tens of thousands of patients may have been given incorrect blood-test results, been subject to unnecessary or potentially harmful treatments and/or been denied the opportunity to seek treatment for a treatable condition,” the plaintiff, an Arizona resident identified only by initials, said in the complaint.
The lawsuit, filed Wednesday in federal court in San Francisco, seeks class-action status on behalf of consumers whose blood was tested through the Palo Alto, California-based company.
At issue are the company’s Edison machines, proprietary devices that Theranos said could generate lab tests using a few drops of blood. Last week, the company said it voided two years of Edison machine data as well as tests run on other machines.
“The lawsuit filed today against Theranos is without merit and the company will vigorously defend itself,” spokeswoman Brooke Buchanan said in a telephone interview.
Theranos’s business has grown mainly through its partnership with Walgreens Boots Alliance Inc., with about 40 of its testing centers placed in Walgreens outlets in Arizona. The plaintiff visited a Theranos center in Tempe, according to the complaint.
The suit alleges claims of misrepresentation, false advertising and unfair business practices.
The case is M.P.B. v. Theranos, 16-cv-2810, U.S. District Court, Northern District of California (San Francisco).