What EntroGen does

EntroGen, Inc. is a privately held molecular diagnostics company headquartered in Woodland Hills, California, founded in 2007. The company develops and commercializes real-time PCR and next-generation sequencing (NGS) assays for oncology and hematology applications, including companion diagnostics, mutation detection panels, liquid biopsy (ctDNA) assays, microsatellite instability testing, pharmacogenomic genotyping kits, and minimal residual disease (MRD) detection products. Its flagship product, the CRCdx RAS Mutation Detection Kit, received FDA approval in October 2023 as a companion diagnostic for Vectibix (panitumumab) in colorectal cancer and secured CMS national coverage in April 2025, while several other products carry CE-IVD marking for the European market. All products are manufactured under ISO 13485 quality standards and supported by proprietary data analysis software (EPAS and EVA) for result interpretation and LIS/LIMS integration.

The company operates an enterprise go-to-market model combining direct sales with a global network of authorized distributors, targeting clinical diagnostic laboratories, oncology research institutions, and pharmaceutical CDx programs. Revenue is generated primarily through one-time sales of reagent kits priced on a quote basis with net 30 payment terms, alongside instrument sales (BenchBot 4800) and royalty-free software licenses. Strategic clinical collaborations, such as a 2017 partnership with USC Norris Comprehensive Cancer Center for liquid biopsy clinical utility studies, and ongoing CDx development support for pharmaceutical sponsors are part of the commercial mix. Marketing is conducted through industry conferences, scientific webinars, peer-reviewed publications, and direct inquiry funnels rather than mass-market channels.

EntroGen is led by CEO Matthew Minkovsky and Chief Science Officer Dr. Gary Potikyan, with an employee base reported in the 11-50 range. The product line has expanded materially since 2016, with notable launches including the Colorectal Cancer Mutation Detection Panel, BRCA Complete NGS panel, Leukemia Translocation Panel, NGS Targeted Hotspot Panel, ctDNA EGFR and RAS kits, and three new offerings in 2025 (NPM1 One-Step MRD Kit, DPYD Genotyping Kit, and MSI Detection Kit), reflecting a strategy of menu breadth across tumor types and clinical applications.

Name

EntroGen

Legal name

EntroGen, Inc.

Website

https://entrogen.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

EntroGen is a privately held molecular diagnostics company based in Woodland Hills, California that develops PCR- and NGS-based oncology assays, including an FDA-approved companion diagnostic, for clinical laboratories, oncology research institutions, and pharmaceutical CDx programs.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Molecular diagnostics
• Oncology diagnostic kits
• Companion diagnostics
• PCR assay reagents
• Next-generation sequencing panels

Headquarters

HQ city

Woodland Hills

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Reagent Kits: EntroGen generates revenue through the sale of molecular diagnostic reagent kits for oncology applications. Products include real-time PCR assays, NGS panels, and companion diagnostics sold as one-time purchases to clinical and research laboratories.
2. Instrument Products: Sale of instruments including the BenchBot 4800 automation system. Instruments come with standard 12-month warranties and optional extended service plans.
3. Software Licenses: Software products including EPAS, EVA, and data analysis tools are licensed to customers. The license is royalty-free, non-exclusive, non-transferable for internal business purposes.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels5 records

Core offering

EntroGen manufactures and sells molecular diagnostic reagent kits (real-time PCR assays and NGS panels) for oncology and hematology applications, along with the Benchbot 4800 automation instrument and EPAS/EVA data analysis software. Products are sold to clinical laboratories, research institutions, and pharmaceutical companies as FDA-approved companion diagnostics, CE-IVD-marked in vitro diagnostics, and research-use-only assays covering mutations in KRAS, NRAS, BRAF, EGFR, PIK3CA, NTRK, DPYD, MSI, BRCA, and other cancer-relevant biomarkers.

Product overview

EntroGen is a molecular diagnostics company specializing in oncology diagnostics with a portfolio of PCR-based and NGS-based products. The core offering consists of real-time PCR mutation detection kits for various cancer biomarkers (KRAS, NRAS, BRAF, EGFR, PIK3CA, DPYD, MSI, NTRK fusions), automated instruments (Benchbot 4800), companion diagnostics (CRCdx RAS Mutation Detection Kit), and sample preparation/quality control products (pureNA DNA Isolation Kits, IQCA). The product line includes targeted therapies companion tests, liquid biopsy assays (ctDNA), NGS panels (BRCA Complete, RNA Fusion Gene Panel, NGS Targeted Hotspot Panel), and genotyping assays. Products work with established instrument platforms including Illumina sequencers and QuantStudio PCR instruments. The portfolio is completed by proprietary data analysis software (EPAS, EVA) for result interpretation.

Differentiator

Problem solved

Functional benefit

Brands

• CRCdx: FDA-approved real-time PCR-based companion diagnostic brand for RAS mutation detection in colorectal cancer
• DPYD Genotyping Kit
• MSI Detection Kit
• Benchbot 4800
• EPAS

Products and services

• CRCdx RAS Mutation Detection Kit FDA-approved real-time PCR-based in vitro diagnostic companion test for detecting 35 KRAS and NRAS somatic mutations in colorectal cancer tissue samples. Helps identify patients who may benefit from Vectibix (panitumumab) anti-EGFR therapy. 40 tests per kit, 2-hour turnaround time. For clinical laboratories performing oncology molecular diagnostics.
• NPM1 One-Step MRD Kit Highly sensitive assay detecting NPM1 mutations at 0.001% sensitivity level for quantitative minimal residual disease (MRD) assessment in leukemia patients. For clinical and research laboratories.
• DPYD Genotyping Kit Multiplex real-time PCR assay for rapid detection of clinically relevant DPYD germline variants associated with reduced dihydropyrimidine dehydrogenase activity and fluoropyrimidine toxicity. Detects 7 AMP Tier 1 variants. 26 tests per kit. For research use (RUO).
• Microsatellite Instability (MSI) Detection Kit High-resolution melting (HRM) PCR-based assay for fast, reliable MSI detection in colorectal cancer. Detects BAT-25, BAT-26, NR-21, NR-27, and MONO-27 targets. 24 tests per kit. Includes complimentary software for data analysis. For research use (RUO).
• Colorectal Cancer Mutation Detection Panel PCR-based assay detecting somatic mutations in KRAS, NRAS, BRAF, PIK3CA, and AKT1 genes associated with colorectal cancer. 48 tests per kit, detects 45 mutations across 6 reactions per sample. Validated for FFPE and fresh frozen samples. CE-IVD marking in EU; RUO in USA.
• MLH1 Methylation Detection Kit Real-time PCR assay using methylation-sensitive restriction enzymes to detect MLH1 promoter methylation in regions C and D. Enables prescreening for Lynch Syndrome and distinguishing sporadic MSI-high tumors. 24 tests per kit, 3-hour turnaround time.
• KRAS Mutation Analysis Kit Real-time PCR-based assay for detecting somatic KRAS mutations. Below 1% limit of detection. 50 tests per kit, 12 reactions per sample. Detects mutations in codons 12, 13, 61, 117, and 146.
• KRAS/BRAF Mutation Analysis Kit Rapid real-time PCR assay detecting KRAS and BRAF mutations to identify mCRC patients unlikely to benefit from EGFR-targeted therapy. 50 tests per kit, 13 reactions per sample.
• NTRK Fusion Gene Detection Kit Real-time qPCR assay detecting 65 NTRK1, NTRK2, and NTRK3 gene fusion variants from FFPE RNA samples. Used for cancer diagnosis and targeted therapy selection for Trk inhibitor treatments. 48 tests per kit, 8 reactions per sample.
• RNA Fusion Gene Panel for Illumina Multiplexed next-generation sequencing assay detecting 305 fusion genes across 23 cancer-associated genes. Includes reagents for reverse transcription, target enrichment, and library preparation. Compatible with Illumina NextSeq 500, MiniSeq, and MiSeq. Average amplicon size 145 bp.
• PIK3CA Mutation Analysis Kit Real-time PCR assay detecting 11 somatic PIK3CA mutations in HR-positive HER2-negative breast cancer and KRAS wild-type metastatic colorectal cancer. 48 tests per kit, 6 reactions per sample. 2-hour turnaround.
• ctDNA RAS Mutation Detection Kit Plasma-based assay for detecting KRAS and NRAS mutations in circulating tumor DNA. Liquid biopsy test for when tumor tissue is limited. 40 tests per kit, 2 reactions per sample.
• ctDNA EGFR Mutation Detection Kit Ultra-sensitive real-time PCR assay for detecting EGFR mutations from circulating tumor DNA in plasma. Detects mutations in exons 18, 19, 20, and 21. 48 tests per kit, 7 reactions per sample.
• EGFR Mutation Analysis Kit Highly sensitive real-time PCR assay detecting key EGFR mutations in exons 18-21 for guiding targeted cancer therapy decisions. 52 tests per kit. Includes complementary EPAS analysis software.
• EGFRX Mutation Analysis Extension Kit Real-time PCR add-on assay expanding EGFR-RT52 kit coverage for rare EGFR mutations in codons L858, L861, and E709. 1% limit of detection. 52 tests per kit, 3 reactions per sample.
• Lung Cancer RNA Panel One-step RT-qPCR assay for detecting ALK, ROS1, and RET fusion genes and MET exon 14 skipping mutations in non-small cell lung cancer. 48 tests per kit. Optimized for FFPE, fresh-frozen, and tumor biopsies.
• BRAF Codon 600 Mutation Analysis Kit II Real-time PCR assay detecting BRAF exon 15 somatic mutations. Detects as low as 1% mutant allelic frequency. 64 tests per kit, 5 reactions per sample. Works with FFPE, fresh frozen, FNA, and plasma samples.
• c-Kit Mutation Detection Kit Real-time PCR assay detecting somatic c-KIT mutations in GIST, melanoma, and mastocytosis. Below 5% limit of detection. 44 tests per kit. Detects 21 mutations including EX11, EX17, EX13, EX9 variants.
• BRCA Complete NGS Panel Targeted NGS panel for BRCA1 and BRCA2 exome sequencing. Compatible with blood, fresh frozen, and FFPE samples. 2% limit of detection, 95% uniformity. Validated for Illumina MiniSeq, MiSeq, and NextSeq platforms. CE-IVD marked.
• NGS Targeted Hotspot Panel NGS assay detecting somatic mutations and copy number variations across 16 cancer genes including BRAF, EGFR, KRAS, NRAS, PIK3CA, TP53. 200 amplicons, average 164 bp. Compatible with FFPE, fresh frozen, blood, and cell lines. Validated for Illumina platforms.
• UGT1A1 Genotyping Kit Real-time PCR assay for differentiation of UGT1A1*1 and *28 polymorphisms in human genomic DNA. Detects promoter polymorphisms for pharmacogenomics applications including irinotecan toxicity assessment. 50 tests per kit.
• Leukemia Translocation Panel Multiplexed one-step RT-PCR assay detecting eleven variants in 6 common leukemia-associated translocations (AML1-ETO, CBFB-MYH11, MLL-AF4, TEL-AML1, E2A-PBX1, PML-RARA). Results in 90 minutes. CE-IVD marked.
• Benchbot 4800 Automated sample processing instrument for molecular diagnostics workflows. Streamlines the process from sample to PCR plate in four simple steps. Standard 12-month warranty with optional extended service plans.
• pureNA Genomic DNA Isolation Kit Magnetic bead-based genomic DNA extraction kit for FFPE tissue samples. High-purity DNA suitable for qPCR and NGS applications. 50 extractions per kit.
• pureNA Cell-Free DNA Isolation Kit Cell-free DNA extraction kit from fresh or frozen plasma. High specificity for cfDNA versus genomic DNA. Processes samples in under 1 hour, recovering cfDNA from as little as 2ml plasma.
• Library Quantification for Illumina qPCR-based kit for accurate quantification of Illumina sequencing libraries. Selectively amplifies adapter-ligated DNA fragments. Includes pre-diluted standards, primer mixes, and 2X master mix. 75 triplicate reactions.
• EPAS Software (EntroGen PCR Analysis Software) Proprietary data analysis software for streamlined PCR/qPCR result interpretation and reporting. Generates easy-to-interpret reports exportable for integration with laboratory information management systems (LIS/LIMS). Bundled with EntroGen reagent kits including CRCdx and EGFR Mutation Analysis Kit.
• EVA Software (EntroGen Variant Analysis Software) Proprietary bioinformatics software for NGS data interpretation. Reports fusion gene identities and genomic breakpoint positions. Used with RNA Fusion Gene Panel and NGS Targeted Hotspot Panel. Available for local installation.

Quantifiable outcome

• CRCdx showed PPA = 99.6%, NPA = 92%, and OPA = 96.2% concordance vs FDA-approved Praxis Extended RAS Panel
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature6 records

Partnerships

One partnership is on record.

• University of Southern California Norris Comprehensive Cancer CentercoreStrategic or Co-development Partner · 12 June 2017Clinical collaboration to conduct an observational study determining the clinical utility of EntroGen's liquid biopsy solutions for lung cancer patients. The year-long study assesses and monitors EGFR activating and resistance mutations in blood of NSCLC patients undergoing EGFR TKI therapy. Dr. Jorge Nieva serves as principle investigator.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Qiagen: Qiagen offers the therascreen line of FDA-approved companion diagnostics (KRAS, EGFR, etc.) and a broad real-time PCR and NGS oncology portfolio. It is the most directly comparable commercial peer to EntroGen in the molecular diagnostics kit business.
• Asuragen (Bio-Techne): Asuragen, now part of Bio-Techne, sells molecular diagnostic kits for oncology including KRAS, BRAF, and other mutation detection assays. Directly comparable product profile (PCR-based oncology kits, CLIA-validated workflows) to EntroGen.
• Amoy Diagnostics: Amoy Diagnostics is a China-headquartered molecular diagnostics company specializing in PCR-based companion diagnostics for oncology (EGFR, KRAS, ALK, ROS1). Comparable product overlap and clinical oncology focus, though primarily serving the Asian market.
• Bio-Rad Laboratories: Bio-Rad offers QXDx and ddPCR-based molecular diagnostic kits for oncology and hematology applications, including KRAS and other mutation detection assays. Comparable as a specialty molecular diagnostics kit provider targeting clinical and research labs.

Broad incumbents

• Illumina: Illumina provides the NGS platforms (MiSeq, MiniSeq, NextSeq) on which EntroGen's BRCA Complete, RNA Fusion Gene Panel, and NGS Targeted Hotspot Panel run. Broad incumbent enabling the NGS-based portion of EntroGen's portfolio while also offering competing oncology NGS content.
• Roche Diagnostics: Roche offers the cobas line of FDA-approved KRAS, EGFR, BRAF, and other oncology companion diagnostics. Broad incumbent dominating the IVD oncology market with vertically integrated instrument-reagent-software workflows.
• Thermo Fisher Scientific: Thermo Fisher (Applied Biosystems) supplies the QuantStudio real-time PCR platform, TaqMan mutation detection assays, and Oncomine NGS panels used across oncology molecular diagnostics. Broad incumbent that both enables (instrument platform) and competes with EntroGen.

Regional players

• NeoGenomics: NeoGenomics is a US-focused oncology clinical laboratory offering molecular testing services (KRAS, EGFR, NGS panels) to oncologists and biopharma. Adjacent comparable in oncology molecular diagnostics but operates as a service lab rather than a kit manufacturer.

Emerging players

• Sysmex: Sysmex provides hematology and molecular diagnostics products, including leukemia and MRD-related assays. Comparable as a specialty diagnostics provider with overlap in EntroGen's Leukemia Translocation Panel and NPM1 MRD Kit categories.
• HTG Molecular Diagnostics: HTG Molecular Diagnostics offers molecular profiling assays for oncology using proprietary technology. Comparable as a small-cap molecular diagnostics company pursuing oncology biomarker and companion diagnostic applications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/entrogen-inc-

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about EntroGen