Tempus AI (TEM) announced the FDA has granted approval for a tumor-only indication for its xT CDx next-generation sequencing platform. The company noted that, with the expanded label, Tempus is the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. The approval paves the way for the company to migrate its entire DNA solid tumor portfolio to FDA-approved assays priced under its current ADLT pricing.
"As we have previously highlighted, we expect an estimated $200 ASP benefit beginning in 2027 as a result of this approval," said Jim Rogers, CFO.
In pre-market trading on NasdaqGS, Tempus shares are up 7.39 percent to $55.08.
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