Caris Life Sciences
Precision oncology company (NASDAQ: CAI) combining comprehensive molecular profiling with AI interpretation. MI Cancer Seek received FDA approval in November 2024 and is, per the company, the first and only assay performing simultaneous whole exome and whole transcriptome sequencing with FDA approved companion diagnostic indications for solid tumors, analyzing more than 23,000 genes from a single tissue sample for adult and pediatric patients. The CodeAI platform runs over a large multimodal clinico genomic dataset to generate Caris AI Insights, a set of proprietary signatures predicting therapy response, tissue of origin, and metastasis risk, delivered in the Caris Molecular Tumor Board Report. Signatures added through 2026 include brain metastasis risk in breast and lung cancer, trained on 12,994 NSCLC and 3,371 breast cancer cases with matched survival outcomes. MI Clarity applies AI and computational pathology to stratify breast cancer recurrence risk without genomic sequencing. Caris Assure is the blood based platform. Went public in June 2025 raising $494 million; biopharma partners include a large alliance with Merck KGaA.
Capability Axes
The AI Insights signatures and the CodeAI platform are genuine model outputs, and MI Clarity is AI native, applying computational pathology to stratify recurrence risk with no genomic sequencing required. Held back from A because the flagship revenue product, MI Cancer Seek, is a sequencing assay whose FDA approved companion diagnostic function rests on the molecular profiling itself; the AI signatures are layered on top of it.
Clinical and analytical validation of MI Cancer Seek was published, and the AI signatures disclose their training cohorts with specificity, including 12,994 NSCLC and 3,371 breast cancer cases with matched survival outcomes for the brain metastasis signatures. Publishing cohort sizes for individual model signatures is materially more transparent than aggregate accuracy claims.
A distinction buyers can easily miss, and the company documents it rather than blurring it: MI Cancer Seek holds FDA approval with companion diagnostic indications, while the Caris AI Insights signatures delivered in the Molecular Tumor Board Report are research use only. The company's own materials caution against inferring that all available services are FDA approved and publish a summary of what falls in and out of the approved labeling. Clear scoping of what is approved and what is not is precisely what this axis rewards.
Structure is partially disclosed rather than priced. The Molecular Tumor Board Report containing the AI signatures is stated as available at no additional cost when ordering MI Cancer Seek, which is a real commercial disclosure. Test pricing itself is not published and runs through diagnostic reimbursement channels; biopharma data partnerships are separately negotiated. As a public company (NASDAQ: CAI) aggregate revenue is disclosed in filings, but test level pricing is not.
Precisely bounded: solid tumor molecular profiling for adult and pediatric patients aged one and older with previously diagnosed malignancy, with signature level specificity by cancer type including colon, breast, ovarian, pancreatic, and lung.
Pricing
Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.
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Per test through diagnostic reimbursement; separate biopharma partnership agreements | — | — | Vendor Published |
Test level pricing is not published and flows through diagnostic reimbursement rather than a rate card. One commercial fact is disclosed and material: the Caris Molecular Tumor Board Report containing the AI Insights signatures is stated as available at no additional cost when ordering MI Cancer Seek. Biopharma data and discovery partnerships are separately negotiated. Caris is publicly traded (NASDAQ: CAI), so aggregate revenue appears in filings while test pricing does not.