Header: The Caris MI Cancer Seek test garners FDA approval as a comprehensive genomic profiling test plus several companion diagnostic claims.
Being an NGS test including CDx claims, it should have automatic on-label coverage under the CMS NCD for NGS tests in cancer. The policy, in use since 2018, is designed to be an incentive for seeking FDA approval. Other CGP tests getting FDA approval this year include tests from Tempus (lab-based) and TSO from Illumina (kit-based).
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See the extensive press release here:
According to the AAPC website, the code for Caris MI Cancer Seek is 0211U, which is priced on the clinical laboratory fee schedule at $8455. (The CMS price was set by the additive crosswalk method several years ago). The test includes DNA exome and RNA transcriptome.
In the next couple weeks, FDA will post online the test's safety & effectiveness validation. Caris has posted a 64-page validation document:
https://www.carislifesciences.com/wp-content/uploads/2024/11/MICancerSeek_TechnicalLabel.pdf
Caris writes in part, "MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors." The test tracks single variants and indels in 228 genes. The test has 7 indications, including breast cancer, colon cancer, melanoma, lung cancer, and "solid tumors" for MSI (microsatellite instability for Keytruda).
