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MI Cancer Seek FDA Companion Diagnostic Indications

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We perform comprehensive bioinformatics testing on DNA, RNA and proteins at our state-of-the-art, 66,000 sq. ft. laboratory in Phoenix, Arizona. In fewer than 14 days, Caris Life Sciences assesses and packages clinically relevant information to help healthcare providers inform the creation of medical therapies that are more effective because they are tailored to specific cancer subtypes.

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Companion Diagnostic Indications

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. MI Cancer Seek is available for adult and pediatric (ages 1-22) patients.

Breast Cancer

36.1%

PIK3CA
Prevalence Rate2

Biomarkers Detected

PIK3CA (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y)

FDA-approved Therapy

PIQRAY® (alpelisib)

Clinical Recommendations

PIK3CA mutations are often found in advanced or metastatic breast cancer, especially in HER2-negative cases.1 

Colorectal Cancer

46-66%

KRAS and NRAS

wild-type

Prevalence Rate5

Biomarkers Detected

KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild-type (absence of mutations in exons 2, 3, and 4)

BRAF V600E

FDA-approved Therapy

VECTIBIX® (panitumumab)

BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab)

Clinical Recommendations

The tumor genotypes of KRAS, NRAS, and BRAF should be determined in all metastatic CRC (mCRC) patients, preferably by next-generation sequencing (NGS).3  

BRAF V600E mutation is a strong negative prognostic factor in mCRC. BRAF mutation status should be assessed simultaneously with RAS testing for prognostication and for the option of treatment with cetuximab-encorafenib.4

Melanoma

40-60%

and 5-30%

BRAF V600E or V600K mutations

Prevalence Rate7

Biomarkers Detected

BRAF V600E
BRAF V600E or V600K

FDA-approved Therapy

BRAF inhibitors approved by FDA*

MEKINIST® (trametinib) or BRAF/MEK inhibitor combinations approved by FDA*)

Clinical Recommendations

If BRAF V600E is negative, testing for other BRAF mutations (like V600K) and NRAS and c-KIT mutations should be considered.6

Guidelines recommend the use of BRAF and MEK inhibitors, such as dabrafenib/trametinib or encorafenib/binimetinib, as first-line or second-line treatment options for patients with BRAF V600E or V600K mutations.7

Non-Small Cell Lung Cancer

20%

EGFR exon 19 deletions and exon 21 L858R mutation

Prevalence Rate8

Biomarkers Detected

EGFR exon 19 deletions and exon 21 L858R alterations

FDA-approved Therapy

EGFR tyrosine kinase inhibitors approved by FDA*

Clinical Recommendations

Broad molecular profiling is strongly recommended with the goal of identifying driver mutations for which targeted therapies or clinical trials may be available.8

To improve detection of gene fusions, RNA-based sequencing is recommended in patients where DNA sequencing does not identify driver mutations.8

Solid Tumors

3.8%

MSI-H

Prevalence Rate10

Biomarkers Detected

MSI-H

FDA-approved Therapy

KEYTRUDA® (pembrolizumab),

JEMPERLI® (dostarlimab)

Clinical Recommendations

The FDA has approved more than ten targeted therapies for use across all solid tumors based on a range of molecular biomarkers:9

NTRK gene fusionsMSI-H, dMMRRET gene fusionsTMB-HBRAF V600EHER2-positive
entrectinib
larotrectinib
repotrectinib		dostarlimab
pembrolizumab		selpercatinibpembrolizumabdabrafenib + trametinibtrastuzumab deruxtecan

Endometrial Cancer

69.3%

Not MSI-H

Prevalence Rate12

Biomarkers Detected

Not MSI-H

FDA-approved Therapy

KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib)

Clinical Recommendations

Molecular analysis has identified four clinically significant molecular subgroups of endometrial carcinoma: POLE mutations, MSI-H or mismatch repair deficient (dMMR), no specific molecular profile (NSMP), and p53 aberrant.11

Comprehensive molecular profiling is strongly encouraged during initial evaluation via an FDA-approved assay or a validated test performed in a CLIA-certified laboratory.11

*For the most current information about the device indications for the therapeutic products in this group, go to:

https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools#Group_Labeling

PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. JEMPERLI® (dostarlimab-gxly) is a registered trademark owned by the GSK group of companies. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

  1. Turner NC, Im SA, Saura C, et al. (2024) Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 391, 1584-1596.
  2. NCCN Clinical Practice Guidelines in Oncology for Breast Cancer V.4.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 17, 2025. 
  3. NCCN Clinical Practice Guidelines in Oncology for Colon Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 24, 2025.
  4. Cervantes A, Adam R, Roselló S, et al. (2023) Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol 34, 10-32.
  5. Kafatos G, Niepel D, Lowe K, et al. (2017) RAS mutation prevalence among patients with metastatic colorectal cancer: a meta-analysis of real-world data. Biomark Med 11, 751-760.
  6. Amaral T, M. Ottaviano M, Arance A, et al. (2025) Cutaneous melanoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol 36, 10-30.
  7. NCCN Clinical Practice Guidelines in Oncology for Melanoma: Cutaneous V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 5, 2025.
  8. NCCN Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 5, 2025.
  9. National Cancer Institute. (June 24, 2024) Drugs approved for solid tumors anywhere in the body. Retrieved May 5, 2025 from https://www.cancer.gov/about-cancer/treatment/drugs/solid-tumors
  10. Bonneville R, Krook MA, Kautto EA, et al. (2017) Landscape of microsatellite instability across 39 cancer types. JCO Precis Oncol 1, 1-15.
  11. NCCN Clinical Practice Guidelines in Oncology for Uterine Neoplasms V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 5, 2025.
  12. Mendiola M, Heredia-Soto V, Ruz-Caracuel I, et al. (2023) Comparison of methods for testing mismatch repair status in endometrial cancer. Int J Mol Sci 24, 14468.
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