Federal agents visited Proove Biosciences' offices this week to issue a subpoena and execute a search warrant, the company says in a statement, adding that it was not a 'raid.'
"In the spirit of full cooperation, we have accommodated their requests," Proove says, adding that the company will cooperate with future requests.
In the statement, Proove attributes the attention it received from federal authorities in part to two reports appearing at Stat News late last year and early this year that questioned the company's practice of paying doctors who enrolled patients in the company's study and cast doubt on its test's ability to predict opioid addiction risk.
Katrina Lewis, a member of the company's medical advisory board who has ordered thousands of Proove tests, told GenomeWeb last year that the payments covered the time that she spent filling out paperwork for the trial and that she or her institute would receive between $500 and $1,000 a month. Such arrangements have raised ethical eyebrows, the Boston Globe reported in 2015, as they could provide an incentive for doctors to order unneeded tests.
In a separate statement, Proove argues that there is published, peer-reviewed support for its tests. It says that it licensed an algorithm that a University of North Carolina-Chapel Hill-led team of researchers reported on in a number of journal articles and used that algorithm as the basis for its pain test. Proove also says that its opioid risk test weighs both genetic and other factors in its algorithm and that there is published data supporting the inclusion of those factors.
Yale University School of Medicine's Joel Gelernter also told GenomeWeb last year that the studies Proove cited at the time to support what it includes in its opioid risk test were "predominantly small, candidate gene studies that were OK for the time, but with the knowledge of today we recognize them as being quite underpowered." Others also expressed skepticism that the test captures opioid addiction risk to the Philadelphia Inquirer.
Proove adds in its statement that it has resumed full-scale operations.