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.
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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.
