MDXHEALTH INC.

Company Overview

MDxHealth Inc., founded in 2003 as a spin-out from Radboud University Medical Center, is developing and marketing diagnostics assays for urologic cancers, including prostate, bladder and kidney cancer. A key strategic focus of the company is to develop a liquid biopsy test for identifying patients at low risk for prostate cancer. MDxHealth operates a CLIA laboratory in Irvine, Calif., and a laboratory in Nijmegen, the Netherlands.

MDxHealth’s technology platforms are based on epigenetics-based biomarkers for detecting the presence of cancer and for assessing the extent of its progress. MDxHealth markets both tissue-based and liquid biopsy-based diagnostics.

MDxHealth’s urology-related tests include ConfirmMDx, SelectMDx, AssureMDx, and InformMDx.

ConfirmMDx uses residual tissue from previous negative biopsies to rule out cancer-free men from undergoing unnecessary future biopsies and/or rule in men who may need repeat biopsies and guidance regarding future prostate biopsies.

SelectMDx is a urine-based mRNA-based assay that is used to stratify patients who have clinical evidence of possible prostate cancer, such as an elevated PSA. The test classifies patients into higher and lower risk groups, helping to avoid unnecessary follow-up.

For prostate cancer, there are 1.8 million biopsies performed per year in the United States and Europe. Only 500,000 of these are positive for cancer, so there is a significant medical need for reducing the number of unnecessary biopsies.

In February 2018, MDxHealth partnered with IDI (Fondazione Luigi Maria Monti–Instituto Dermopatico dell’ Immacolata) research hospital (Rome, Italy) to offer SelectMDx as a service through IDI’s laboratory. This agreement helped with market penetration in the Italian market.

In June 2018, MDxHealth formed an alliance with Philips covering the recently validated phosphodiesterase-4D7 prostate cancer biomarker as a prognostic test. This agreement allows the PDE4D7 biomarker to be used in the InformDx test, which is being developed. InformDx is a tissue-based prostate cancer test that helps provide clinicians with guidance for post-biopsy and post-prostatectomy treatment decisions.

In September 2023, MDxHealth SA announced a research collaboration with the University of Oxford to investigate the correlation between the Genomic Prostate Score (GPS) test and prostate cancer progression following treatment for localized prostate cancer.

In August 2022, MDxHealth SA finalized an asset purchase agreement with Genomic Health Inc., a subsidiary of Exact Sciences Corp. This agreement entails the acquisition of the Oncotype DX GPS (Genomic Prostate Score) test from Exact Sciences, along with the inclusion of a significant portion of its urology sales and marketing professionals.

Financial Highlights (FY 2023)

Company's Business Segments

• Services : MDxHealth services segment provides Actionable Molecular Diagnostic Information to personalize the Diagnosis, Treatment of Prostate Cancer, Other Urologic Diseases. The Company’s tests are based on Proprietary Genetic, Epigenetic, Other Complex Molecular Technologies.