Sunday, February 18, 2018

Liquid Biopsy Panel from Guardant Health Awarded "EXPEDITED PATHWAY" at FDA

On February 15, 2018, Guardant Health announced that its multi-gene liquid biopsy somatic mutation panel has received the prestigious "Expedited Access Pathway" designation from the FDA. 

According to co-founder Helmy Eltouky, "Our FDA submission for Guardant360 is Guardant Health's top priority for 2018."  Press release here.

Liquid biopsy is a high visibility space, with 1060 hits currently on Pubmed.    FDA and AACR held a conference on the topic a few months ago in October 2017, decks and transcripts here.

Within the field, Guardant Health has been a leading player, having raised an additional $360M in May 2017 (here).    According to this week's press release, the value of the Guardant G360 has been supported by  >30 clinical outcome studies.

Update: Field of Liquid Biopsy.

On March 15, 2018, Genomeweb had an article detailing the discontinuation of the Oncotype liquid biopsy assay, "citing a shift to tests that are proprietary."  Genomeweb (subscription).  This announcement had been made in GHDX's early March investor call, if not before.  The company also announced a staff downsizing of 10%.