Friday, April 22, 2016

News Tidbit: FDA Backs Off A Sole-Source LDT Enforcement Effort

News tidbit.  In November 2015, the FDA sent Interleukin Genetics (Waltham, MA) a formal letter finding that the FDA had no records of FDA review, clearance, or approval of its LDT test "PerioPredict."  FDA letter to the comapny here; Genomeweb here.

This was about 24 months after Interleukin issues a policy statement comparing its LDT tests to the LDTs tests offered direct to consumer by 23andMe (here.)

On April 5, 2016, Interleukin issued a press release that via discussions with FDA, PerioPredict had been confirmed as the type of genomic LDT that was currently under enforcement discretion (here).  Interleukin's press release is fairly detailed and worth reading for those with an interest in this field.

Interleukin Genetics is a small independent company which trades over the counter and has a current market cap of $19M (ILIU; here).  It had total revenue of $1.4M in CY2015 and an operating loss of $7.9M.