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.
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.