FDA Approval for Sole-Site TEMPUS "xT CDx" Test
See a new May 1, 2023 press release on Tempus receiving FDA approval for its 648-gene xT CDx test. The test is NGS-based, includes a CDx (FDA label) gene for colorectal cancer, and includes microsatellite instability.
As an FDA-approved CDx NGS test, it should merit immediate national coverage from Medicare, under NCD 90.2. This is the same coverage status that the original Foundation F1 CDx FDA test has, as well as more recent NGS liquid biopsy tests from Guardant and Foundation Medicine.
As an FDA-approved, sole-site test, the xT CDx test should also qualify for special "ADLT" pricing rules at CMS. This include 9 months of CMS pricing at the company's list price.
The test includes analysis of germline DNA from a matched blood or saliva specimen. So far, AMA CPT has not created a code for large gene panel tests that include germline testing.
Tempus also posted a 27-page PDF document about the test:
Like the Foundation test, the test is approved both specifically as a companion diagnostic (colorectal cancer; KRAS) and for "tumor mutation profiling in solid malignant neoplasms" - e.g. any solid cancer. Both purposes are covered under Medicare's NCD 90.2.
The test runs on a Illumina NovaSeq 6000 platform.
Caris received FDA breakthrough status for a tumor profiling test in 2019 and has been in FDA review since 2020, per press releases. The Caris test includes exome and transcriptome.
AI - - - - - - - - -
ChatGPT4 summarizes the press release as a haiku.
FDA nod for Tempus,
xT CDx guides care,
Gene light in darkness.