Exagen Diagnostics Inc., of Vista, Calif., has agreed to pay slightly more than $653,000 to resolve allegations that it had paid specimen processing fees to physicians to induce those physicians to use Exagen’s lab tests.
News from Truvian Health Inc. that its benchtop blood testing platform can deliver results similar to those generated by central laboratory is promising for the diagnostic sector still coming to terms with fraudulent claims from companies such as Theranos Inc. and Arrayit Corp. that their various technologies were able to run an array of tests with just a few drops of blood.
The litigation over the fraud perpetrated by Theranos Inc. and its executives is still legally relevant, but another Silicon Valley company and its founder have been indicted over misrepresentations to investors over liquid biopsy technologies that were purported to work with just a few drops of blood. A jury recently convicted Mark Schena, the president of Palo Alto-Calif.-based Arrayit Corp., of defrauding investors and causing false claims to be submitted to federal health programs, another example of how investors can be easily misled by hucksters plying the diagnostics trade.
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.