- No public price.
- Not disclosed
- Not disclosed
- —
- 2008
- US
Pathology
Caris Life Sciences
by Caris Life Sciences · founded 2008 · US
FDA-approved MI Cancer Seek tumor profiling test for oncologists. The GPSai tissue-of-origin AI is a lab service outside that approval.
On this page
65/100
Editorial rating 4.5 / 5
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength21/28.8
5 peer-reviewed papers
- Vendor & Market14.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers21/21
5 peer-reviewed papers
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market6/6
Founded 2008 (18 years)
- Pricing transparency3/5
Pricing on request, no public amounts
FDA-approved MI Cancer Seek tumor profiling test for oncologists. The GPSai tissue-of-origin AI is a lab service outside that approval.
No public price.
Evidence record
PMAP240010 (opens in new tab)November 5, 2024
MI Cancer Seek
5 studies on PubMed: 5 other, published 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Caris Life Sciences record, https://medaiverdict.com/tools/caris-life-sciences, version November 2, 2026
Bottom line
Caris Life Sciences, founded in 2008 and listed on Nasdaq as CAI, is a tumor-profiling lab in Irving, Texas, and its FDA approval, PMA P240010 of November 5, 2024, covers the MI Cancer Seek sequencing assay and its companion diagnostic claims. The vendor's MI Cancer Seek page lists the GPSai tissue-of-origin model and FOLFIRSTai under professional services, outside the FDA-approved scope. Oncology practices ordering tumor profiling with companion diagnostics are the audience the approval serves. A practice buying GPSai or FOLFIRSTai is buying lab services without that approval.
What does the approval cover?
openFDA lists P240010 as "MI Cancer Seek" with the generic name "Next generation sequencing oncology panel, somatic or germline variant detection system", reviewed by the Medical Genetics advisory committee. The assay profiles FFPE tumor tissue with whole exome and whole transcriptome sequencing. It reports single nucleotide variants and indels in 228 genes, MSI, TMB and a copy number alteration in one gene for breast. The page quotes a median turnaround of 8 days and elsewhere 6 to 9.
The vendor page lists companion diagnostic claims such as PIK3CA for Piqray, KRAS and NRAS wild-type for Vectibix, and BRAF V600E for Braftovi with cetuximab. It also lists claims for melanoma, MSI-H tumors, EGFR and endometrial cancer. The page cautions that some offerings do not have FDA companion diagnostic approvals. MI Tumor Seek Hybrid is described as a laboratory developed test, and the vendor lists MI Profile and MI Tumor Seek Hybrid as available outside the USA, EEA, EU and Switzerland.
Which Caris products use AI?
GPSai predicts tissue of origin and runs automatically on each sample. FOLFIRSTai is named on the vendor page without a description. Caris MI Clarity applies AI and computational pathology to H&E slides, with no sequencing, to estimate distant recurrence risk in early HR+/HER2-negative node-negative breast cancer. The portfolio also includes Caris Assure for blood, Caris ChromoSeq for myeloid whole-genome sequencing and Caris Detect, a multi-cancer early detection blood test.
What has been published on GPSai?
A 2021 Translational Oncology paper (PMID 33465745) applied machine learning to 77,044 tumor profiles to predict tumor type, and the same journal ran a comment and a response on GPSai validation in cancer of unknown primary. A 2025 Cancer Research Communications paper carries the title "GPSai: A Clinically Validated AI Tool for Tissue of Origin Prediction during Routine Tumor Profiling". A 2026 JAMA Network Open study used GPSai to separate lung squamous cell carcinoma from metastases, and it has Caris-affiliated authors. In August 2026 Caris news announced an npj Precision Oncology study on AI-guided therapy selection in pancreatic cancer.
How is MI Cancer Seek ordered?
The vendor claims EHR ordering at more than 3,100 locations without naming the systems, and the pages state HITECH compliance and encryption. No price accompanies the MI Cancer Seek listing.
The verdict
The decision splits at the approval line. An oncology practice ordering MI Cancer Seek for a drug with a listed companion diagnostic claim, such as Piqray, Vectibix or Braftovi, orders an FDA-approved assay. A practice ordering GPSai or FOLFIRSTai orders a lab service the vendor places outside that approval, so the FDA-approved result comes from the assay and not from those two signatures.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
Who builds it
Caris Life Sciences (Caris Life Sciences) was founded in 2008 in US, putting it 18 years into market.
What the literature says
5 peer-reviewed studies indexed on PubMed evaluate Caris Life Sciences in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- An AI Approach to Differentiating Lung Squamous Cell Carcinoma From Metastases of Other Origins. (opens in new tab)
- Evans MG, Ribeiro JR, Maney T, et al.· JAMA Netw Open· 2026
- Distinguishing primary lung squamous cell carcinoma (SCC) from squamous metastases to the lung is a clinical challenge due to histopathologic similarities. Accurate diagnosis is essential to guide treatment decisions. To assess the utility of an artificial intelligence (AI) approach that includes evaluation of key orthogonal evidence in distinguishing primary lung SCCs from metastatic tumors of other tissue origins. This cross-sectional study used GPSai, a tissue-of-origin AI model run automatically on each sample submitted for molecular profiling, to flag potential misdiagnoses among researc…
- Proactive identification of candidates for newly approved targeted therapies using a clinical decision support program. (opens in new tab)
- Feldman R, Abdulla F, Hinton A, et al.· Oncologist· 2026
- Comprehensive molecular profiling (CMP) enables identification of multiple biomarkers from a single sample to inform targeted therapy selection. However, the static nature of test reports limits their clinical relevance as new therapies emerge. Based on the presence of molecular alterations, the population of patients qualifying for FDA-approved therapies nearly doubled since 2017, while FDA-recognized biomarkers of drug response quadrupled. Lookback programs are clinical decision support services designed to notify clinicians when previously profiled patients become candidates for new target…
- ERBB2/HER2 landscape and prognostic impact: large-scale, real-world analysis across solid cancers. (opens in new tab)
- Shreenivas A, Elliott A, Corbiere T, et al.· ESMO Open· 2026
- We evaluated the frequency and prognostic impact of human epidermal growth factor receptor 2 (HER2) protein expression [immunohistochemistry (IHC)] and correlations with ERBB2 genomic alterations in a large database of molecularly profiled real-world patients (Caris Life Sciences, Phoenix, AZ). We analyzed 206 750 tumors for ERBB2 copy number alterations and pathogenic mutations (using next-generation sequencing) and 88 530 samples for HER2 IHC data (stratified as 0, 1+, 2+, or 3+). RNA (whole transcriptome) was also evaluated. Overall survival (OS) was based on real-world insur…
- Investigating the determinants of immunotherapy response in the primary tumour of clear cell renal cell carcinoma (RCC). (opens in new tab)
- Tang C, Poduval D, Lee S, et al.· BMJ Oncol· 2026
- Immune checkpoint inhibitors (ICIs) have demonstrated durable clinical benefit in a subset of patients with metastatic renal cell carcinoma (RCC), yet the molecular features that govern therapeutic response within the primary tumour remain poorly defined. This is of particular importance in the current era, where cytoreductive nephrectomy is less commonly performed and many patients with metastatic disease still have the primary RCC tumour in place. To deepen our understanding of ICI response in the primary tumour and to understand the evolution of RCC on ICI, we conducted a comprehensive gen…
- Distinct genomic landscapes of mismatch-repair deficiency (dMMR)/microsatellite instability-high (MSI-H) gastrointestinal (GI) cancer depending on tumor mutation burden (TMB) levels. (opens in new tab)
- Wang J, Xiu J, Farrell AP, et al.· J Immunother Cancer· 2026
- Tumor mutation burden (TMB) is a predictive biomarker for immune checkpoint inhibitor (ICI) treatment in mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) cancers. We aimed to characterize specific molecular features of dMMR/MSI-H gastrointestinal (GI) tumors with a range of TMB levels. A total of 2272 GI tumors tested as dMMR/MSI-H were analyzed using next-generation sequencing (NGS) and immunohistochemistry (IHC) (Caris Life Sciences, Phoenix, Arizona, USA). Molecular features were compared in four groups (TMB <10 vs 10–20 vs 20–50 v…
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