Diagnostics

From PCR, FISH, IHC technologies to now the expanding applications of next-generation sequencing (NGS), biomarker targeted therapies are improving clinical outcomes. Furthermore, applications of circulating tumor DNA (ctDNA) testing have provided options for less invasive procedures while also providing more accurate and precise evaluation of tumor heterogeneity.

VERI tracks 600+ oncology diagnostic tests across global jurisdictions and across all oncology indications. Pulling news and data from recent regulatory approvals, social media, trial data releases, conference abstracts and other research publications, VERI can keep you up to date on both the diagnostic market landscape and the latest applications of new diagnostic tests in oncology.

Diagnostics

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4D Lifetest™ Lung Dx	Lung Cancer	4D Lifetec	CE-IVD (Old IVDD)
ACTOnco	Breast Cancer Colon Cancer Endometrial Cancer ...	Prenetics	FDA Cleared (510k)
ASPYRE-Lung	Lung Cancer	Biofidelity	Laboratory Developed Test
AVENIO ctDNA Expanded Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AVENIO ctDNA Surveillance Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AVENIO ctDNA Targeted Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AlphaLiquid® 100	Breast Cancer Colon Cancer Gastric Cancer ...	IMBdx	CE Marked
AmoyDx® JAK2 Mutation Detection Kit	Lung Cancer	Amoy Diagnostics	Research Use Only
AmpliMark™	Lung Cancer Urothelial Cancer	Lucence	Laboratory Developed Test
AnchorAIM® 10 Gene Test for Individualized Treatment of Lung Cancer	Lung Cancer Non Small Cell Lung Cancer	AnchorDx	Laboratory Developed Test
Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit	Lung Cancer Thyroid Gland Carcinoma	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Lung Kit	Lung Cancer	Integrated DNA Technologies	Research Use Only
Archer® VariantPlex® Comprehensive Thyroid and Lung (CTL) kit	Lung Cancer Thyroid Gland Carcinoma	Integrated DNA Technologies	Laboratory Developed Test
Aspyre® Lung	Lung Cancer	Biofidelity	Laboratory Developed Test
C2inform test	Bladder Cancer Colorectal Cancer Glioblastoma ...	Veracyte	CE-IVD (Old IVDD)
CanScan™	Endometrial Cancer Esophageal Cancer Gastric Cancer ...	Geneseeq	CE Marked
Cancerguard™	Breast Cancer Cervical Cancer Colorectal Cancer ...	Exact Sciences Corp	Laboratory Developed Test
Canhelp-Lung® Assay	Lung Adenocarcinoma Lung Cancer Lung Non-Small Cell Squamous Cancer	Canhelp Genomics	Other Approval
CyPath® Lung	Lung Cancer	bioAffinity Technologies	Laboratory Developed Test
DEEPGEN™ Panel	Bladder Cancer Breast Cancer Cervical Cancer ...	Quantgene	Laboratory Developed Test
Dawn™	Lung Cancer Melanoma Pancreatic Cancer	Intervenn Biosci	Laboratory Developed Test
DetermaCNI™	Lung Cancer	Oncocyte	Laboratory Developed Test
EarlyCDT®-Lung	Lung Cancer	Freenome	CE Marked
Epi proLung®	Lung Cancer	Epigenomics	CE Marked
Epi-TOP LUNG assay	Lung Cancer	Seasun Biomaterials	Laboratory Developed Test
EpiLung assay	Lung Cancer	Epigenomics	Laboratory Developed Test
FirstLook Lung	Lung Cancer	Delfi Diagnostics	Laboratory Developed Test
GUARDANT SHIELD	Colorectal Cancer Lung Cancer	Guardant Health	FDA Approved (PMA)
Galleri Test	Adrenal Cortex Carcinoma Ampulla of Vater Carcinoma Anal Carcinoma ...	GRAIL	Laboratory Developed Test
GeneseeqPrime™	Lung Cancer Solid Tumor	Geneseeq	CE Marked
HTG EdgeSeq Oncology Biomarker Panel (OBP)	Breast Cancer Colorectal Cancer Lung Cancer ...	HTG Molecular Diagnostics	Research Use Only
HTG Transcriptome Panel	Breast Cancer Colorectal Cancer Lung Cancer ...	HTG Molecular Diagnostics	Research Use Only
Idylla™ ctEGFR Mutation Assay	Lung Cancer	Biocartis	Research Use Only
InVisionSeq™	Acute Myelogenous Leukemia Bladder Cancer Brain Cancer ...	NeoGenomics	Laboratory Developed Test
Ion AmpliSeq Colon and Lung Cancer Research Panel v2	Colon Cancer Lung Cancer	Thermo Fisher Scientific	Research Use Only
Lena S1®	Lung Cancer	Alercell	Laboratory Developed Test
LiquidHALLMARK®	Breast Cancer Colon Cancer Endometrial Cancer ...	Lucence	Laboratory Developed Test
LiquidLung™	Lung Cancer	IV BioHoldings	Laboratory Developed Test
Lung Cancer 8-Gene Kit	Lung Cancer	Genetron Health	CE Marked
Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit	Lung Cancer	BGI Group	CE Marked
Lung EpiCheck®	Lung Cancer	Nucleix	Laboratory Developed Test
LungCanSeek® test	Lung Cancer	SeekIn	Laboratory Developed Test
Lunit SCOPE IO	Biliary Tract Cancer Bladder Cancer Breast Cancer ...	Lunit	Research Use Only
MSC miRNA test	Lung Cancer	AccuStem	Laboratory Developed Test
NEO-MRD® assay	Breast Cancer Colorectal Cancer Head and Neck Cancer ...	NeoGenomics	CE Marked
NGS Targeted Hotspot Panel	Acute Myelogenous Leukemia Bladder Cancer Breast Cancer ...	EntroGen	CE-IVD (Old IVDD)
NeoLAB® Solid Tumor Liquid Biopsy	Bladder Cancer Breast Cancer Colorectal Cancer ...	NeoGenomics	Laboratory Developed Test
NeoTYPE® Lung Tumor Profile	Lung Cancer	NeoGenomics	Laboratory Developed Test
Nodify CDT™	Lung Cancer Non Small Cell Lung Cancer	Biodesix	Laboratory Developed Test
Nodify Lung	Lung Cancer	Biodesix	Laboratory Developed Test
Nodify XL2™	Lung Cancer	Biodesix	Laboratory Developed Test
Nu.Q® Lung Cancer Test	Lung Cancer	Volition	Laboratory Developed Test
ONCOCATCH-S	Lung Cancer	Eone Diagnomics Genome Center	Laboratory Developed Test
OncoKey™ SL 525 Plus Assay	Bladder Cancer Breast Cancer CNS Tumor ...	Luye Group	Laboratory Developed Test
OncoKey™ SL 60 Plus Assay	Bladder Cancer Breast Cancer Colorectal Cancer ...	Luye Group	Research Use Only
OncoMasTR test	Bladder Cancer Breast Cancer Colorectal Cancer ...	Danaher Corp	CE Marked
OncoPanel™ Assay	Colorectal Cancer Gastrointestinal Stromal Tumor Lung Cancer ...	Cancer Genetics and Genomics Laboratory	Laboratory Developed Test
OncoScreen™ IO	Bladder Cancer Breast Cancer Colorectal Cancer ...	Burning Rock Biotech	Laboratory Developed Test
OncoaccuPanel™	Breast Cancer Colon Cancer Gastric Cancer ...	NGeneBio	CE Marked
OncobiotaLUNG assay	Lung Cancer	Micronoma	Laboratory Developed Test
Oncomine Lung Cell-Free Total Nucleic Acid Research Assay	Lung Cancer	Thermo Fisher Scientific	Research Use Only
OptiSeq™ Lung Cancer & Colon Cancer Early Detection Panel	Colon Cancer Lung Cancer	DiaCarta	Laboratory Developed Test
OptiSeq™ Lung Cancer Panel	Lung Cancer	DiaCarta	Laboratory Developed Test
PANAMutyper™ R EGFR	Lung Cancer	Panagene	CE-IVD (Old IVDD)
PANAMutyper™ R KRAS	Colorectal Cancer Lung Cancer	Panagene	Other Approval
Portrait® PD-L1 test	Lung Cancer Solid Tumor	ANGLE	Research Use Only
PulmoSeek Lung Cancer Early Detection Assay	Lung Cancer	AnchorDx	CE Marked
QClamp® BRAF Mutation Detection Test	Colorectal Cancer Lung Adenocarcinoma Lung Cancer ...	DiaCarta	CE-IVD (Old IVDD)
SOLIDaccuTest DNA	Breast Cancer Colorectal Cancer Lung Cancer ...	NGeneBio	CE Marked
SOPHiA DDM Dx RNAtarget Oncology Solution	Lung Cancer	Sophia Genetics	CE-IVD (Old IVDD)
SOPHiA DDM™ Solid Tumor Plus Solution	Brain Cancer Colorectal Cancer Lung Cancer ...	Sophia Genetics	Research Use Only
SPOT-MAS Test	Biliary Tract Cancer Breast Cancer Colorectal Cancer ...	Gene Solutions	Laboratory Developed Test
TruBlood®	Bladder Cancer Breast Cancer CNS Tumor ...	Datar Cancer Genetics	CE Marked
TruSight Oncology 500 Assay	Bladder Cancer Breast Cancer Colon Cancer ...	Illumina	Research Use Only
TruSight Oncology Comprehensive	Breast Cancer CNS Tumor Colorectal Cancer ...	Illumina
U-TOP MSI detection kit	Biliary Tract Cancer Bladder Cancer Colorectal Cancer ...	Seasun Biomaterials	Laboratory Developed Test
UW-Oncoplex™	Leukemia Lung Cancer Melanoma ...	University of Washington	Laboratory Developed Test
Velox™	Breast Cancer Colorectal Cancer Kidney Cancer ...	Thermo Fisher Scientific	Laboratory Developed Test
ctDNA EGFR Mutation Detection Kit	Lung Cancer	EntroGen	CE-IVD (Old IVDD)
ctDNAaccuPanel™ Lung	Lung Cancer	NGeneBio	Laboratory Developed Test
nCounter® PanCancer Progression Panel	Lung Cancer Prostate Cancer	NanoString Technologies	Research Use Only