Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Oncology Ngs topic
No spam. Unsubscribe anytime.
Thermo Fisher presents Oncomine DX Express; panel questions absence of MSI/TMB and requests gene list
Summary
Thermo Fisher told the CMS CLFS meeting that PLA 0648U Oncomine DX Express is FDA approved and nationally covered under Medicare NCD 90.2; the company highlighted automation and rapid results, while CMS panelists asked for the gene list and flagged the assay’s lack of MSI and tumor‑mutation‑burden reporting.
Rob DeMonaway, director of reimbursement strategy for Thermo Fisher’s clinical sequencing division, presented PLA 0648U (Oncomine DX Express), a next‑generation sequencing assay that reports DNA and RNA alterations from FFPE tissue and is intended to inform oncology therapy decisions. DeMonaway said the test is FDA approved, carries a DEXZ identifier and ‘‘secured national coverage under Medicare’s NCD 90.2.’’ He highlighted automation on the Genexus DX system and said the test reports expanded molecular content — 46 genes in this assay versus smaller panels used as comparators.
A CMS panelist asked for a complete gene list and by‑tumor‑type guidance on which guideline‑recommended biomarkers are covered. In exchange, DeMonaway said Thermo Fisher would follow up with a gene list and confirmed that the assay does not calculate microsatellite instability (MSI) or tumor mutation burden (TMB). "This assay does not include MSI or TMB calculations," the presenter stated when asked how immunotherapy‑relevant biomarkers are addressed.
The panel also probed sensitivity and sample‑failure rates for FFPE on the Genexus workflow and how the test compares on cost, tissue requirements and turnaround time to more comprehensive panels; Thermo Fisher offered to provide follow‑up data to the panel and post additional information. The company recommended crosswalks to existing PLA codes with which it argued clinical and analytical characteristics overlap.
Next steps: Thermo Fisher will provide the panel and CMS staff with the requested gene lists, performance metrics and concordance data for further review.
