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Insight Molecular Diagnostics Inc. Announces Favorable Medicare Coverage Decision Supporting Commercial Adoption Of GraftAssure Assay Portfolio
Insight Molecular Diagnostics Inc. highlighted a favorable new Medicare policy supporting expanded coverage for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care. 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. 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. 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 Insight Molecular Diagnostics Inc.’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 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. Insight Molecular Diagnostics Inc.’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. 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. The final policy also cites Insight Molecular Diagnostics Inc.-affiliated research utilizing GraftAssure technology. Insight Molecular Diagnostics Inc.’s flagship technology has a reimbursement rate from Medicare of $2,753 per result. This rate is for GraftAssureCore, a lab-developed test to measure dd-cfDNA that is run in the company’s Tennessee laboratory. Eventually, through a process known as “bridging,” that reimbursement rate would extend to GraftAssureDx, which has been submitted for FDA review and is awaiting FDA marketing authorization. The company seeks to allow other labs to purchase the GraftAssureDx kits to perform the test themselves and bill Medicare at the same rate, which would happen after FDA marketing authorization is achieved. Insight Molecular Diagnostics Inc. is at a pivotal stage in commercializing its GraftAssure technology, which Insight Molecular Diagnostics Inc. expects to be an industry-transforming transplanted organ rejection monitoring test. The company aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. Insight Molecular Diagnostics Inc. has designed a molecular test that it can sell as a test kit to help enable transplant center laboratories to run tests locally and deliver critical test results far more quickly than the current send-out tests. The company is now seeking FDA marketing authorization to sell these kits to transplant centers in the U.S. Over time, Insight Molecular Diagnostics Inc. sees three potential paradigm shifts in transplanted organ health monitoring: Bringing testing closer to the patient: The first is a shift in where donor-derived cell-free DNA (dd-cfDNA) testing is performed – migrating out of centralized reference laboratories and into hospital-based laboratories capable of delivering results locally. Expanding the clinical role of dd-cfDNA: The second is the growing potential for dd-cfDNA testing, powered by digital PCR technology, to support earlier detection of allograft injury, longitudinal monitoring of transplant health, and assessment of response to emerging anti-rejection therapies. Advancing from rule-out to comprehensive decision support: The third is a transition from the current rule-out-biopsy testing paradigm toward a more comprehensive rule-out and rule-in approach, enabled by GraftAssure’s ability to measure both dd-cfDNA percentage and absolute, or true, concentrations as copies per milliliter of plasma. Insight Molecular Diagnostics Inc.’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The Company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. Insight Molecular Diagnostics Inc. is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure brand, Insight Molecular Diagnostics Inc.’s transplant diagnostics include the following: GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at Insight Molecular Diagnostics Inc.’s CLIA-certified laboratory in Franklin, Tennessee. GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications. GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA review for use in clinical decision-making.