MDxHealth

What MDxHealth does

MDxHealth is a commercial-stage molecular diagnostics company specializing in precision tests for prostate cancer and urologic diseases. Its portfolio includes tissue-based assays (Confirm mdx for detecting occult cancer after negative biopsy, and GPS mdx, the 17-gene Genomic Prostate Score assay for treatment decision support in localized prostate cancer) and liquid-based tests (Exo mdx, an exosomal RNA/protein biomarker test with at-home collection and Level 1 clinical evidence). The company also previously offered Resolve mdx for urinary tract infection diagnosis before discontinuing the product in 2025 following a Medicare recoupment dispute. Technology centers on proprietary gene expression signatures, epigenetic biomarkers, and exosome profiling processed through CAP-accredited, CLIA-certified laboratories in Irvine (CA), Waltham (MA), and Plano (TX).

MDxHealth operates a sales-led go-to-market model, distributing tests through direct enterprise sales representatives targeting urologists, oncologists, and large urology group practices. Physicians order through a dedicated portal (mdxhealthsecure.com), with specimens shipped via FedEx to company labs and results returned for clinical decision-making. Reimbursement is handled by an in-house patient advocate team and revenue cycle management function. Primary customers are practicing urologists and prostate cancer patients, with secondary reach into infectious disease specialists (historically) and academic research collaborations (notably University of Oxford for the GPS-ProMPT study and upcoming ProtecT trial). The company also serves as a partner channel for the ProtecT trial, embedding its test into one of the largest prostate cancer cohorts globally.

Revenue is generated through fee-for-service laboratory testing, recognized when specimens are processed. The company has grown from approximately $22M in 2021 to $107.88M TTM through Q4 2025, with Q4 2025 revenue up 19% YoY and test volumes up 62% (liquid tests specifically up 128%). Management has guided to 27-30% top-line growth for 2026. MDxHealth has funded growth through public equity offerings on NASDAQ ($37M in 2023, $40M in 2024, and a $200M shelf filed in December 2025) and strategic acquisitions, including the Oncotype DX GPS business from Exact Sciences (2022, up to $100M) and Exosome Diagnostics from Bio-Techne (2025, up to $15M). The company is publicly traded on NASDAQ (ticker MDXH), domiciled in Belgium with primary US operations headquartered in Irvine, California.

Name

MDxHealth

Legal name

MDxHealth SA

Website

https://mdxhealth.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

251–500 employees

Short description

MDxHealth is a commercial-stage molecular diagnostics company offering tissue-based and liquid biopsy tests, primarily for prostate cancer risk assessment and treatment decision support, serving urologists, oncologists, and prostate cancer patients across the United States.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF)

akta.pro secondary industry

Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC)

Keywords

• Molecular diagnostics
• Prostate cancer testing
• Genomic assays
• Liquid biopsy
• Urologic diagnostics

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Molecular Diagnostic Testing Services: MDxHealth generates revenue through laboratory testing services, processing patient specimens (tissue and liquid biopsies) and providing diagnostic results to physicians. Revenue is recognized when tests are performed, with Q4 2025 revenue of $29.5 million representing 19% year-over-year growth.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

MDxHealth is a molecular diagnostics company that develops and commercializes epigenetic and genomic tests for prostate cancer and urologic disease assessment. The company operates CAP-accredited, CLIA-certified laboratories in the United States and processes tissue and liquid biopsy specimens sent by physicians, returning risk stratification and treatment guidance results. Core offerings include the tissue-based Confirm mdx and GPS mdx assays, the liquid-biopsy Exo mdx test, and the Resolve mdx urine-based infectious disease test.

Product overview

MDxHealth is a molecular diagnostics company offering a portfolio of genomic and exosome-based diagnostic tests for prostate cancer and other urologic cancers. The company's product portfolio includes Confirm mdx (a gene expression test for prostate cancer risk assessment), GPS mdx (a 17-gene genomic assay acquired from Exact Sciences for prostate cancer aggressiveness scoring), and Exo mdx (an exosome-based liquid biopsy platform). MDxHealth previously offered Resolve mdx for UTI testing, but this product line appears to have been discontinued. All tests are performed in the company's CAP-accredited and CLIA-certified laboratories.

Differentiator

Problem solved

Functional benefit

Brands

• Confirm mdx: Prostate cancer test addressing biopsy sampling error and false-negative biopsy dilemma
• GPS mdx
• Exo mdx
• Resolve mdx
• Select mdx

Products and services

• Confirm mdx A molecular diagnostic test that analyzes gene expression patterns (epigenetic biomarkers) from prostate biopsy tissue to help distinguish between aggressive and indolent prostate cancer, addressing prostate biopsy sampling error and the false-negative biopsy dilemma. Used by urologists and other physicians ordering follow-up testing after a negative biopsy.
• GPS mdx (Genomic Prostate Score) A 17-gene tissue-based genomic assay that predicts prostate cancer aggressiveness and provides risk scores for metastasis within 10 years and prostate cancer-specific death within 10 years. Designed for men with low-, intermediate-, and high-risk localized prostate cancer to help guide treatment decisions. Originally acquired from Exact Sciences as Oncotype DX GPS.
• Exo mdx A liquid-based prostate cancer test that uses exosome profiling (exosomal RNA and protein biomarkers) from a blood sample to detect and characterize prostate cancer and enhance patient stratification for prostate biopsy decisions. Supports at-home specimen collection and is supported by Level 1 clinical evidence.
• Resolve mdx A urine-based diagnostic test for infectious disease applications, including urinary tract infection (UTI) detection and pathogen identification. Performed at MDxHealth's CAP-accredited laboratory in Plano, Texas.
• Select mdx Molecular diagnostic test in the MDxHealth portfolio featuring urine collection, supporting prostate cancer and urologic disease assessment.

Quantifiable outcome

• 92% six-year freedom-from-failure in active surveillance patients with favorable GPS scores
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered strategic and core.

• University of OxfordstrategicStrategic or Co-development Partner · 16 March 2026Collaboration with Oxford's GPS-ProMPT study demonstrated the prognostic value of the GPS mdx test across 409 patients over six years. MDxHealth announced next phase collaboration with initiation of GPS mdx testing in the landmark UK ProtecT trial.
• Exact Sciences (GPS Earnout Amendment)coreStrategic or Co-development Partner · 9 January 2026MDxHealth amended its GPS acquisition earnout obligations with Exact Sciences on January 9, 2026, deferring remaining payments into 2026-2028 and issuing warrants for 3 million MDxHealth shares to manage near-term cash obligations.
• Bio-Techne (Exosome Diagnostics)coreStrategic or Co-development Partner · 15 September 2025MDxHealth acquired Exosome Diagnostics Inc. from Bio-Techne in September 2025 for up to $15 million, adding the ExoDx test and a CLIA-certified laboratory to its platform. This expanded MDxHealth's prostate cancer diagnostics through liquid-based testing capabilities.
• Exact SciencescoreStrategic or Co-development Partner · 2 August 2022MDxHealth acquired the Oncotype DX GPS (Genomic Prostate Score) prostate cancer business from Exact Sciences for up to $100 million including cash, stock, and earn-outs. This acquisition significantly strengthened MDxHealth's position in the urology and prostate cancer diagnostic market.

Scale indicators9 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Exact Sciences: MDxHealth acquired Exact Sciences' Oncotype DX GPS prostate cancer business in 2022 for $100M. Exact Sciences remains a major oncology diagnostics competitor with Cologuard and Oncodetect, and shares the same end customer (urologists/oncologists) and broader precision oncology positioning.
• Myriad Genetics: Myriad's Prolaris test directly competes with GPS mdx in prostate cancer treatment-decision risk stratification. Both companies serve urologists with molecular tests designed to guide active surveillance versus treatment decisions.
• Natera: Natera operates in oncology molecular diagnostics with Signatera (MRD) and Empower (hereditary cancer), targeting similar oncology/urology call points. Its Signatera test is increasingly being studied for prostate cancer, creating direct future overlap with MDxHealth's franchise.

Broad incumbents

• Guardant Health: Guardant Health is a leading liquid biopsy company focused on oncology. While not currently focused on prostate cancer risk stratification, its liquid biopsy platform (Guardant360, Shield) represents a credible competitive threat as liquid biopsy moves into urology.
• NeoGenomics: NeoGenomics provides oncology-focused clinical lab services including molecular and genetic testing, with overlapping sales channels into community oncology and urology practices. Comparable business model as a cancer-focused diagnostic lab services company.
• Veracyte: Veracyte is a genomic diagnostics company offering tests across urology (Decipher Prostate — a direct competitor to GPS mdx) and other specialty areas. Highly comparable in business model, target end market, and clinical evidence approach.
• Opko Health (BioReference Laboratories): Opko Health operates clinical laboratories (BioReference) and develops molecular diagnostics, including 4Kscore for prostate cancer risk assessment. Competes directly with MDxHealth's Confirm mdx and Select mdx in the urology call point.
• Hologic (post-Biotheranostics): Hologic acquired Biotheranostics in 2021, gaining the Prostate Cancer Index (Prolaris competitor) — positioning it as a larger commercial competitor in the prostate cancer molecular diagnostic space where MDxHealth also operates.

Emerging players

• Castle Biosciences: Castle Biosciences develops molecular diagnostic tests for dermatologic, ocular, and other cancers. Comparable as a small-to-mid-cap specialty molecular diagnostics company targeting physician call points with proprietary gene-expression-based assays.
• Biodesix: Biodesix is a specialty diagnostics company offering blood-based lung and other cancer tests. Comparable in business model (small-cap specialty molecular diagnostics with proprietary assays targeting physician offices) but operates in different indications.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/MDxHealth
• Facebookfacebook.com/mdxhealth
• LinkedInlinkedin.com/company/mdxhealth

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors8 records

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

M&A3 records

Investments

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

Frequently asked questions about MDxHealth