FBI raids Irvine DNA testing firm Proove

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.