Favorable Medicare Coverage Decision Supports Commercial Adoption of iMDx GraftAssure Assay Portfolio

Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today highlighted a favorable new Medicare policy supporting expanded coverage for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care. The company believes the updated policy, known as a local coverage determination, or LCD, supports the commercial adoption of its GraftAssure ™ family of assays by reinforcing and expanding the Medicare reimbursement framework for dd-cfDNA testing. The policy was issued by MolDX, which is a program run by the Centers for Medicare & Medicaid Services, or CMS, specifically designed to review and decide under what conditions the U.S. government will pay for genetic and molecular tests.

iMDx believes the favorable policy provides additional clarity for hospitals, clinicians, and laboratories, supports patient access to reimbursable dd-cfDNA testing, and further aligns with the company's strategy to enable in-house dd-cfDNA testing. Specifically:

The policy reaffirms the value of dd-cfDNA testing in transplanted organ health monitoring. The new policy establishes a baseline for long-term surveillance testing for transplanted organ patients, which gives clarity to hospitals, clinicians, and laboratories, representing iMDx’s future expected kitted transplanted organ rejection monitoring assay customers. The policy supports a higher testing frequency through the allowance of surveillance coverage in addition to the already-covered for-cause testing. This higher testing frequency, outlined below, is favorable to the company’s publicly stated $2 billion total addressable market for kitted transplanted organ testing. The company also believes that the higher frequency of allowed testing strengthens the economic case for transplant centers to bring dd-cfDNA testing in-house. iMDx’s immediate focus is kidney transplant testing, followed by heart transplant testing.

The final policy establishes the following covered surveillance testing frequencies, which represent an increase across all organ types compared with the previous policy. In addition, relative to the draft policy published last year for public comment, the company notes the following changes Year 1: Reimbursable kidney transplant surveillance testing in the first-year post-transplant has increased from four tests in the draft policy to six tests in the final policy. Heart testing frequency remains unchanged at twelve tests in the first year after transplant surgery. Years 2 and 3: In the second and third years after a transplant surgery, dd-cfDNA testing frequency for both kidney and heart transplant patients doubled from two tests per year in the draft policy to four tests per year in the final policy. Years 4 and beyond: For the remaining life of the patient, the draft policy had proposed two tests per year. The final policy removes that testing rate ceiling, provided the testing frequency has clinical utility, which iMDx believes is a ...