Monday, February 4, 2019

Brief Blog: Illumina Trusight Panel at FDA; Breakthrough Status; Pan Cancer + TMB

In lat January 2019, Illumina announced that a version of its Trusight NGS tumor panel is under review at FDA, and further, that FDA had granted it "breakthrough status." 

The test is aiming for "pan cancer" labeling - the same status that the Foundation Medicine FDA CDx test has.  In addition, the test is planned to report tumor mutational burden (TMB). 

So far, there is no FDA-approved pan cancer IVD to compete with Foundation Medicine in both FDA status and pan-cancer profiling.   A pan cancer IVD would be available at large hospitals, academic medical centers, regional reference labs.   If it can be run profitably, it could be a significant competitor to FMI, or at least, shake up the marketplace.

Read More:

Coverage at Med Tech Dive here.  Press release here.  Illumina's most recent quarterly investor call transcript, January 30, 2019, here.  Illumina had 4Q revenue of $876M and free cash flow circa $200M.  Revenue for the year was $3.4B.


In related news, the VA set up a $111M contract (cumulative; 5 years) with Foundation Medicine to provide services to its patients, including F1 CDx, F1 Liquid, F1 Heme - here.