Header: On August 27, 2024, Illumina announces FDA PMA approval of "TSO Comprehensive," an NGS tumor tissue test reporting 500+ genes.
Press release here. TSO stands for, 'TruSight Oncology." Genomeweb here. Endpoints here.
What You Get
The test has several specific companion diagnostic approvals. These are NTRK fusions used with VITRAKVI (larotrectinib) in pediatric and adult solid tumors. And, RET fusion rearrangements in NSCLC, where the paired drug is REVELMO (selpercatinib). The test also reports TMB.
Illumina stock as trended upward from $110 to $130 over several months, but didn't have any additional bump for this news.
My reading of the news is that the test will qualify for national coverage under Medicare NCD 90.2, which gives on-label coverage to NGS tests which are companion diagnostics. Illumina's remarks also state this CMS coverage.
Web Page for TSO FDA
Illumina releases a webpage on the FDA product here. The workflow is listed as 4-5 days TAT. Illumina also posts a 21-page datasheet and a 7-page FAQ (includes full gene lists). They remark, "Kits will ship in November 2024." Kits will run on NextSeq 500Dx.
