Monday, April 29, 2019

Very Brief Blog: LabCorp, OmniSeq - LDT to Become FDA-Approved Tumor Panel

In August 2017, LabCorp and OmniSeq, a genomics reference lab in Buffalo, announced a distribution commitment and investment from LabCorp, here.  In June 2018, they jointly rolled out OmniSeq Advanced, here.

In April 2019, additional investments from LabCorp to OmniSeq were announced, here and here.  Especially, the new resources will fund the ability to pull OmniSeq tests through the FDA pipeline.   This is likely spurred, at least in part, by Medicare's National Coverage Decision to give preferential coverage to FDA-cleared and -approved tumor gene tests.

See OmniSeq's home page here.

Caris has also prepared submissions for FDA (e.g. here).  Illumina has a large tumor panel under review at FDA with breakthrough status, here.  Guardant has a liquid biopsy test with FDA breakthrough status - here.

Medicare has proposed to offer special inpatient new-ech payment status in 2021 and later for breakthrough devices (here).