Find oncology molecular diagnostic tests

Browse curated oncology molecular diagnostic test profiles with intended use, specimen, modality, assay-version context, study populations and source-linked evidence.

  • Afirma GSC — RNA-expression genomic classifier used as a diagnostic aid for cytologically indeterminate thyroid nodules.
  • Altera — Tumor comprehensive genomic profiling using whole-exome and whole-transcriptome sequencing.
  • Avantect Ovarian Cancer Test — Cell-free DNA blood LDT intended as an aid to earlier ovarian-cancer detection in women at elevated risk.
  • Avantect Pancreatic Cancer Test — Blood-based multi-analyte, multiomic test intended to support earlier pancreatic cancer detection in elevated-risk patients.
  • BRCAplus — Guideline-based germline hereditary breast cancer panel.
  • Breast Cancer Index — PCR-based breast tumor gene-expression LDT providing distant-recurrence risk and likelihood of benefit from extended endocrine therapy.
  • CanCatch Custom — Tumor-informed personalized ctDNA MRD approach using WES baseline profiling and patient-specific mutation tracking.
  • Cancerguard — Multi-cancer early detection laboratory-developed test for adults 50–84; breast/prostate screening and precancer detection are outside the documented current use.
  • CancerNext — Guideline-based germline hereditary cancer panel.
  • CancerNext-Expanded — Germline hereditary-cancer panel; current vendor page reports 78 genes while recent official 77-gene materials require explicit version separation.
  • CancerTYPE ID — 92-gene RT-PCR molecular classifier for difficult-to-diagnose metastatic tumors and tissue of origin.
  • CancerVista — ctDNA liquid-biopsy in-house IVD for MRD detection, recurrence surveillance and therapy monitoring across solid tumors.
  • CanScan — Blood-based multi-cancer early detection test using low-depth WGS and AI integration of fragmentomic, genomic and inferred epigenomic cfDNA features.
  • Caris Assure — Whole-blood comprehensive molecular profiling for advanced solid tumors.
  • Caris ChromoSeq — Whole-genome/transcriptome profiling for diagnosed or suspected myeloid malignancies.
  • Caris Detect — Blood-based multi-cancer early detection LDT using whole-genome and whole-transcriptome sequencing with AI.
  • clonoSEQ — NGS-based clonotype assay for measurable/minimal residual disease assessment in lymphoid malignancies, with disease- and specimen-specific FDA-cleared contexts and additional LDT uses.
  • cobas EGFR Mutation Test v2 — FDA-approved real-time PCR EGFR companion diagnostic for NSCLC.
  • Cologuard — Stool-based colorectal cancer screening test for average-risk adults.
  • Cologuard Plus — Prescription multitarget stool-based colorectal cancer screening test for average-risk adults age 45 years or older.
  • ColoHealth — Blood-based methylated SEPT9 colorectal cancer testing family; current ColoHealth Direct LDT and historical FDA device lineage are modeled separately.
  • ColoSense — FDA-approved qualitative stool RNA and occult-hemoglobin colorectal cancer screening test for average-risk adults age 45 years or older.
  • Confirm mdx — PCR-based DNA methylation test performed on prior negative prostate-biopsy tissue to estimate the likelihood of occult clinically significant prostate cancer and inform repeat-biopsy decisions.
  • Decipher Bladder — Gene-expression genomic classifier for prognosis and treatment decision support in bladder cancer.
  • Decipher Prostate — 22-gene prostate-cancer genomic classifier used for prognostic and treatment-decision risk assessment.
  • DecisionDx-Melanoma — Gene-expression profile for risk stratification and management guidance in stage I-III cutaneous melanoma.
  • DecisionDx-SCC — 40-gene expression profile with clinicopathologic integration for metastatic-risk stratification in high-risk cutaneous SCC.
  • DecisionDx-UM — Gene-expression prognostic classifier for metastatic risk in uveal melanoma.
  • EndoPredict — Gene-expression prognostic test for recurrence risk in early-stage HR-positive/HER2-negative breast cancer.
  • EPISEEK — Blood-based multi-cancer early detection LDT analyzing abnormal DNA methylation signals associated with more than 60 cancer types.
  • FirstLook Lung — Blood-based cfDNA fragmentomics laboratory-developed test used as an adjunct in the lung-cancer screening pathway; not a replacement for LDCT.
  • Foresight CLARITY — Ultra-sensitive ctDNA molecular residual disease assay using PhasED-Seq phased-variant detection, with strong current use in B-cell lymphoma clinical programs.
  • FoundationOne CDx — Tissue-based comprehensive genomic profiling and indication-specific companion diagnostic for solid tumors.
  • FoundationOne Heme — DNA/RNA comprehensive genomic profiling LDT for hematologic neoplasms and other source-defined indications.
  • FoundationOne Liquid CDx — Blood-based 324-gene comprehensive genomic profiling and companion-diagnostic test for advanced solid tumors. Regulatory claims are PMA-, supplement-, biomarker-, therapy- and indication-scoped.
  • FoundationOne MRD — Tissue-informed ctDNA MRD assay for stage II-III breast cancer using tumor WGS and multiplex dPCR.
  • Galleri — Prescription-only multi-cancer early detection test.
  • GeneseeqPrime — FDA-cleared next-generation sequencing tumor-profiling assay for FFPE solid-tumor tissue.
  • Guardant Reveal — Tissue-free ctDNA MRD/recurrence and therapy-response monitoring test with current methylation-focused commercial lineage.
  • Guardant360 Liquid CDx — Plasma cfDNA comprehensive genomic profiling and indication-specific companion diagnostic.
  • Guardant360 Tissue — Tissue-based multiomic comprehensive profiling for advanced solid tumors.
  • Haystack MRD — Tumor-informed ctDNA molecular residual disease assay for solid tumors using WES-derived personalized panels tracking up to 50 variants.
  • Invitae Common Hereditary Cancers Panel — NGS germline panel for common hereditary cancer predisposition.
  • Invitae Hereditary Breast and Gyn Cancers Panel — NGS germline panel for hereditary breast and gynecologic cancer predisposition.
  • Invitae Hereditary Colorectal Cancer Guidelines-based Panel — NGS germline panel for hereditary colorectal cancer predisposition.
  • Invitae Hereditary Pancreatic Cancer Panel — NGS germline panel for hereditary pancreatic cancer predisposition.
  • Invitae Hereditary Prostate Cancer Panel — NGS germline panel for hereditary prostate cancer predisposition.
  • Invitae Personalized Cancer Monitoring — Tumor-informed personalized ctDNA monitoring assay for solid tumors.
  • Labcorp Plasma Detect Genome MRD — Tumor-informed whole-genome sequencing ctDNA MRD test currently offered for stage III colon cancer baseline and monitoring.
  • LiquidHALLMARK — Prescription plasma liquid-biopsy assay detecting ctDNA and ctRNA for molecular profiling and treatment selection in advanced cancer.
  • LucenceINSIGHT — Prescription blood-based multi-cancer early detection family using ctDNA and viral DNA with machine-learning tissue localization.
  • LymphoVista — ctDNA sequencing in-house IVD for lymphoma genotyping, MRD assessment and longitudinal monitoring.
  • MammaPrint — 70-gene breast-cancer genomic risk classifier with multiple historical/current platform configurations that must remain version scoped.
  • MI Cancer Seek — FDA-approved tissue NGS comprehensive tumor-profiling and companion-diagnostic device within the Caris MI Profile platform.
  • MI Profile — Caris tissue comprehensive molecular profiling service integrating WES, WTS, protein biomarkers and selected AI signatures for solid tumors.
  • MSK-ACCESS — Institutional ultra-deep cfDNA sequencing assay for noninvasive genomic profiling and disease monitoring; current panel covers 146 genes.
  • MSK-IMPACT — Tumor-normal targeted DNA sequencing for comprehensive tumor profiling.
  • MyChoice CDx — NGS-based homologous recombination deficiency companion diagnostic assessing BRCA1/2 and genomic instability in FFPE ovarian tumor tissue.
  • MyPath Melanoma — 23-gene qRT-PCR expression classifier for ambiguous melanocytic lesions.
  • MyRisk — Germline hereditary-cancer panel; current documented configuration contains 63 clinically recommended genes and must not inherit analytical metrics from historical 25-gene validation.
  • NavDx — Blood-based TTMV-HPV DNA laboratory-developed test used in HPV-driven cancer management and post-treatment recurrence surveillance.
  • NEO PanTracer LBx — 514-gene ctDNA liquid-biopsy comprehensive genomic profiling assay for advanced pan-solid tumors, including MSI-H and bTMB.
  • NEO PanTracer Tissue — 517-gene DNA/RNA tissue comprehensive genomic profiling for solid tumors.
  • NeoTYPE Precision Profile for Solid Tumors — Commercial solid-tumor molecular profiling panel combining targeted NGS with IHC and reflex assays to support treatment selection.
  • NeXT Personal Dx — Tumor-informed personalized ctDNA LDT using WGS-derived patient-specific signatures for MRD, recurrence and treatment-response monitoring.
  • Nodify CDT — Blood autoantibody classifier that raises malignancy risk for selected pulmonary nodules.
  • Nodify XL2 — Blood-based proteomic classifier to identify lung nodules likely benign.
  • Northstar Response — Tissue-free methylated-ctDNA liquid biopsy for quantitative treatment-response monitoring across advanced solid tumors.
  • Northstar Select — 102-gene plasma ctDNA comprehensive genomic profiling assay for therapy selection in advanced solid tumors.
  • Oncodetect MRD — Tumor-informed ctDNA molecular residual disease test used across solid tumors; current commercial configuration tracks up to 200 tumor-specific variants.
  • OncoExTra — Whole-exome and whole-transcriptome tumor profiling with matched-normal subtraction for advanced solid tumors.
  • Oncoguard Liver — Blood-based aid for HCC detection in an at-risk surveillance population.
  • Oncomine Dx Express Test — FDA-approved rapid targeted NGS tumor profiling and companion diagnostic test.
  • Oncomine Dx Target Test — FDA-approved targeted NGS oncology companion diagnostic platform.
  • Oncotype DX Breast Recurrence Score — 21-gene tumor RNA expression assay used in HR-positive, HER2-negative early breast cancer to estimate recurrence risk and inform potential chemotherapy benefit.
  • OneTest for Cancer — Blood-based multi-cancer early detection LDT combining multiple serum tumor biomarkers with a machine-learning risk algorithm.
  • OverC Multi-Cancer Detection — Blood-based cfDNA methylation multi-cancer early detection test with six-cancer current product scope; jurisdiction-specific regulatory status.
  • PanTum Detect — Whole-blood multi-cancer screening aid detecting Apo10/DNaseX and TKTL1 signals in monocytes using EDIM/flow-cytometry-based methodology.
  • PGDx elio plasma focus Dx — FDA-authorized plasma cfDNA next-generation sequencing tumor-profiling test for patients already diagnosed with solid malignant neoplasms.
  • PGDx elio tissue complete CDx — FDA-approved hybrid-capture NGS companion diagnostic on FFPE tumor tissue; current CDx scope includes melanoma BRAF V600E/V600K.
  • Precise MRD — Tumor-informed whole-genome sequencing MRD assay tracking up to 1,000 patient-specific variants for treatment and recurrence monitoring.
  • PredicineCARE — CLIA-certified 200-gene cfDNA assay for treatment selection and comprehensive molecular profiling in solid tumors.
  • Prolaris + AI — Prostate cancer prognostic/treatment-guidance test combining molecular score with clinical/pathology and AI.
  • Prosigna — PAM50/ROR breast-cancer prognostic classifier; historical FDA-cleared nCounter IVD and current US NGS LDT are distinct configurations.
  • ProVue Lung — Proteomics-based blood LDT designed to complement LDCT lung-cancer screening in high-risk adults.
  • RaDaR ST — Personalized tumor-informed ctDNA MRD assay for solid tumors; current ST generation uses WES tumor profiling and tracks up to 48 patient-specific mutations.
  • Shield — Blood-based colorectal cancer screening test.
  • Signatera — Personalized tumor-informed circulating tumor DNA molecular residual disease test family. Includes the FDA-authorized Signatera CDx MIBC companion-diagnostic configuration and broader laboratory-developed clinical uses that remain separately scoped.
  • SimpleScreen CRC — FDA-approved blood-based colorectal cancer screening test for average-risk adults age 45 and older.
  • SimpleScreen Lung — Blood-based multiomic LDT intended to increase lung-cancer screening participation among eligible high-risk adults not completing LDCT.
  • SPOT-MAS 10 — Blood-based multi-cancer screening test using cfDNA methylation and fragmentomic signals with machine learning.
  • Tempus xF+ — 523-gene plasma liquid-biopsy comprehensive genomic profiling assay for therapy selection and molecular profiling in advanced cancer.
  • Tempus xM — Tumor-naive liquid-only MRD assay combining methylation- and variant-based workflows for stage II-III colorectal cancer.
  • Tempus xT CDx — 648-gene tissue comprehensive genomic profiling companion diagnostic.
  • therascreen KRAS RGQ PCR Kit — FDA-approved real-time PCR KRAS companion diagnostic for colorectal cancer.
  • therascreen PIK3CA RGQ PCR Kit — FDA-approved real-time PCR PIK3CA companion diagnostic for breast cancer.
  • ThyGeNEXT + ThyraMIR v2 — Combined NGS mutation/fusion and microRNA classifier workflow for indeterminate thyroid nodules.
  • ThyroSeq Genomic Classifier — Molecular genomic classifier for indeterminate thyroid nodules.
  • Trucheck Intelli — Blood-based multi-cancer early detection test that detects circulating tumor cells and reports likely tissue/tumor context across many solid tumors.
  • TruSight Oncology Comprehensive — DNA/RNA comprehensive genomic profiling assay for solid tumors with indication-specific companion-diagnostic claims.