Mdxhealth offers a portfolio of molecular diagnostic assays that analyze urine or prostate tissue for genetic, epigenetic, and exosomal biomarkers, enabling precise risk stratification of prostate cancer and urinary tract infections. Its tests—Exo mdx, Confirm mdx, GPS mdx, and Resolve mdx—provide non‑invasive cancer detection, identify occult aggressive disease in prior biopsies, quantify tumor aggressiveness, and rapidly pinpoint uropathogens with resistance profiles, helping clinicians make more informed treatment decisions.
Funding
Funding not disclosed
Founders
Product
Problem
Current prostate cancer and urologic disease diagnostics rely on invasive biopsies, limited tissue sampling, and non-specific tests, leading to missed aggressive cancers, unnecessary repeat procedures, and suboptimal treatment decisions.
Solution
mdxhealth provides a suite of molecular diagnostic assays that analyze genetic, epigenetic, and exosomal biomarkers from urine or prostate tissue to deliver actionable risk stratification for prostate cancer and urinary tract infections. The Exo mdx urine test predicts clinically significant cancer before biopsy, reducing unnecessary procedures. Confirm mdx evaluates previously negative biopsy tissue to identify occult aggressive disease, guiding repeat biopsy decisions. GPS mdx quantifies tumor aggressiveness across low‑ to high‑risk localized prostate cancer to inform active surveillance versus definitive therapy. Resolve mdx rapidly identifies uropathogens and resistance genes, enabling personalized antibiotic selection within 24‑48 hours. All tests are supported by proprietary PCR‑based technologies, cloud‑based reporting, and integration with physician portals for secure result access.
Target Audience
Primary customers are urologists, oncologists, and primary‑care physicians managing men at risk for or diagnosed with prostate cancer, as well as clinicians treating urinary tract infections.
Features
- Exo mdx: non‑invasive urine exosome assay with a three‑gene signature (PCA3, SPDEF, ERG) delivering 91 % NPV and 92 % sensitivity for ≥GG2 prostate cancer
- Confirm mdx: methylation‑specific PCR on prior biopsy tissue providing 96 % NPV for Gleason ≥ 3+4 disease and validated in African‑American cohorts
- GPS mdx: 17‑gene expression panel (12 cancer‑related, 5 reference) generating a 0‑100 score that predicts adverse pathology, metastasis, and prostate‑cancer‑specific mortality up to 20 years
- Resolve mdx: PCR‑based detection of 29 uropathogens and 26 resistance genes with ASTX™ susceptibility testing, delivering results in ≤48 hours and eliminating mixed‑flora reports
- At‑home collection kits and Medicare/private‑payer coverage for Exo, Confirm, GPS, and Resolve assays
- Secure, HIPAA‑compliant physician portal for electronic report access, ordering, and test‑kit logistics
- Proprietary DNA‑based technologies (methylation‑specific PCR, exosomal RNA profiling) validated in >10,000 patients and multiple peer‑reviewed studies