FBI raids Irvine DNA test­ing firm Proove

Los Angeles Times - - BUSINESS BEAT - By Jack Flem­ming jack.flem­ming@la­times.com

FBI agents on Wed­nes­day morn­ing raided Proove Bio­sciences, an Irvine com­pany that sells a DNA test it as­serts can de­ter­mine whether a pa­tient is at risk of ad­dic­tion to opi­oid painkillers.

In a news con­fer­ence, FBI spokes­woman Cathy Kramer said the raid was part of an on­go­ing in­ves­ti­ga­tion con­cern­ing health­care fraud. No ar­rests were made.

Anony­mous Proove em­ploy­ees told Stat, a health­care news site, that about 25 agents with a search war­rant spent sev­eral hours re­mov­ing boxes of doc­u­ments. The work­ers had been told by Proove to stay home for the day.

Proove main­tains that its test can de­ter­mine a pa­tient’s risk of ad­dic­tion with 93% ac­cu­racy.

In De­cem­ber, a Stat ar­ti­cle ques­tioned the sci­en­tific ba­sis for Proove’s test. Rock­e­feller Univer­sity’s Dr. Mary Jeanne Kreek, who re­searches ge­netic links to ad­dic­tion, told Stat that Proove’s test was “hog­wash.” In Fe­bru­ary, the site said Proove’s method of pay­ing physi­cians to par­tic­i­pate in clin­i­cal tri­als might vi­o­late anti-kick­back laws.

That ar­ti­cle in­cluded a state­ment from Chief Ex­ec­u­tive Brian Meshkin, who said that “Proove is act­ing within the con­fines of the law … [and in­tends] to fol­low both the let­ter and spirit of the law.”

Meshkin could not be reached for com­ment re­gard­ing Wed­nes­day’s raid.

Proove had 2016 rev­enue of $28 mil­lion, Stat said. The com­pany was able to col­lect more than 100,000 DNA spec­i­mens, largely be­cause of a reg­u­la­tory loop­hole for “lab­o­ra­tory-de­vel­oped tests.” Es­sen­tially, these tests are free from Food and Drug Ad­min­is­tra­tion reg­u­la­tion so long as they’re de­signed, man­u­fac­tured and used within a sin­gle lab­o­ra­tory.

In Novem­ber, the Obama ad­min­is­tra­tion halted plans to close the loop­hole, and the FDA elected to leave the de­ci­sion for the Trump ad­min­is­tra­tion.

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