MDxHealth provides business update

MDxHealth provided clinical and reimbursement product developments, updated guidance for FY22, and initial guidance for 2023. Under the foundational LCD process recently implemented by the Molecular Diagnostics Services Program administered by Palmetto GBA, all tests within an LCD-covered indication must submit a Technical Assessment for review and consideration. The indication for use of Select mdx is covered by Medicare’s foundational LCD Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer, which became effective in July. The Select mdx TA has already been submitted and we are engaged in an interactive review process with MolDX. Based on the company’s most recent communication with MolDX, a final coverage decision is not expected until H1 2023. The recently released NCCN for Prostate Cancer Guideline expands the indication for use of the GPS test to include high-risk patients with localized prostate cancer. In August, mdxhealth announced that it acquired the Oncotype DX Genomic Prostate Score test from Exact Sciences, further solidifying the company’s leadership in the precision diagnostics urology market. This expanded criteria to address high-risk patients provides additional validation for the clinical utility of GPS in making prostate cancer treatment decisions and enables the company to more fully serve its targeted patient population.