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Product Pipeline

MDxHealth’s Pipeline of Molecular Diagnostics (MDx)

Leveraging its patented MSP methylation technology, MDxHealth is developing and commercializing a robust pipeline of prognostic and predictive molecular diagnostic products for multiple cancer types. Through its network of clinical collaborations, the company is commercializing these tests to improve patient outcomes and lower healthcare costs.

For each cancer type, the company will offer a combination of different assays:

ConfirmMDx – Our “Confirm” products will serve as an aid for physicians to assess DNA methylation status associated with presence or absence of cancer.

InformMDx – Our “Inform” products will provide prognostic assessment to distinguish between aggressive and non-aggressive tumors.

PredictMDx – Our “Predict” products will provide predictive information to indicate which drug or treatment regimen is likely to be most effective for the individual patient.

ClinicalMDx

Our Clinical Diagnostic assays are designed to aid in the assessment of the presence or absence of cancer or provide indications of cancer recurrence or aggressiveness.

MDxHealth’s ClinicalMDx products are focused on 3 major cancer areas: prostate, colorectal and lung cancer.

PharmacoMDx - Co-development of CDx

MDxHealth’s PharmacoMDx program is positioned to be a leading source of DNA methylation-based products for oncology.

MDxHealth’s PharmacoMDX program provides:

  • Biomarker discovery
  • Clinical trial service testing
  • Development of companion diagnostics

Today it is estimated that less than 50% of cancer drugs are beneficial to the patients receiving them. Companion diagnostics can help doctors customize or personalize the the treatment for each patient based on the presence or absence of a specific biomarker.

MDxHealth’s PharmacoMDx tests are aimed at distinguishing between drug responders and non-responders. The tests are being designed to help pharmaceutical companies target drug therapies and demonstrate higher drug efficacy rates. MDxHealth’s assays may help expedite the regulatory approval of drugs and reduce the overall costs of drug development.

Facts and figures

  • The need for Pharmaco Molecular Diagnostic products is growing;
  • The costs of Pharmaco Molecular Diagnostic product development are small compared to overall drug development costs;
  • Biomarkers have had a major impact on the development of new oncology therapies, with 27% of cancer treatments approved between 2000 and 2008 being indicated for patients with specific genetic biomarkers;
  • Regulatory authorities are stepping up their demands for biomarkers inclusion in drug development and commercialization;
  • Companion diagnostics can accelerate and improve the outcome of drug development

PharmacoMDx Services

MDxHealth’s PharmacoMDx program is designed to provide innovative biomarker development services for pharma companies to support their drug development program and improve the efficacy of the drug and monitor patients’ response to therapy. The testing services we offer can support biomarker discovery, the validation of companion diagnostic assays as well as clinical trials.