FDA approves tumour-only use of Tempus's 648-gene xT CDx test

Tempus AI/xT CDx genomic profiling

The FDA expanded the xT CDx approval so the test can run on tumour tissue alone when no matched blood or saliva sample is available. Tempus says it is the first lab with FDA companion-diagnostic approval for both tumour-only and tumour-normal profiling, and it can now move all its solid-tumour DNA testing onto approved assays.

• 648 genes; detects small mutations, insertions/deletions and microsatellite instability from preserved tumour tissue.
• Companion diagnostic for cetuximab and panitumumab in colorectal cancer.
• CFO Jim Rogers expects about USD 200 more per test on average from 2027.