MDxHealth cuts outlook

 MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today provided clinical and reimbursement product developments, updated guidance for 2022, and initial guidance for 2023.

Select mdx reimbursement update
Under the foundational LCD (Local Coverage Decision) process recently implemented by the Molecular Diagnostics Services (MolDX) Program administered by Palmetto GBA, all tests within an LCD-covered indication must submit a Technical Assessment (TA) 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 2022. The Select mdx TA has already been submitted and we are engaged in an interactive review process with MolDX. Based on our most recent communication with MolDX, a final coverage decision is not expected until H1 2023.

NCCN Guidelines expand Genomic Prostate Score (GPS) indication to include high-risk patients
The recently released NCCN for Prostate Cancer Guideline (Version 1.2023)* expands the indication for use of the GPS test to include high-risk patients with localized prostate cancer. In August 2022, mdxhealth announced that it acquired the Oncotype DX Genomic Prostate Score® (GPS) 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 us to more fully serve our targeted patient population.

Michael K. McGarrity, CEO of mdxhealth, commented: “Securing Medicare reimbursement for new molecular diagnostic technologies is now a more rigorous and iterative process under the new Foundational LCD program. Due to the additional time required to obtain Medicare coverage, the Company no longer expects to receive Medicare payments for Select mdx tests in 2022. Based on this development, coupled with revenue cycle timing associated with the acquisition and integration of the GPS test, the Company is revising its 2022 revenue guidance to $36.5-37.5 million from $40-42 million. We remain confident in our ability to address any remaining questions with MolDX, which we believe will lead to a positive reimbursement decision for Select mdx in the first half of 2023. To further underscore the growing diagnostic value of Select mdx, we are also pleased to report that the results of an independent, multi-institutional clinical study was recently recognized as a best poster by the American Urological Association, demonstrating the diagnostic accuracy of Select mdx and as well as its complementary utility with mpMRI for the prediction of prostate cancer in biopsies.

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