Verici Dx has welcomed the final MolDx Local Coverage Determination for molecular testing in kidney, heart and lung transplantation.
The policy gives clearer guidance on when molecular and proteomic tests may qualify for Medicare coverage after a solid organ transplant. It covers both surveillance testing and testing used when there is concern about possible rejection.
The decision reduces uncertainty around the reimbursement pathway for advanced transplant diagnostics. Clearer coverage criteria can support adoption by laboratories and clinicians, while giving diagnostic companies a more defined framework for clinical evidence, testing frequency and appropriate use.
The policy recognises that molecular testing can support decisions across the post-transplant pathway. Tests may be used to assess active rejection, evaluate whether immunosuppression is adequate, monitor response to treatment and help determine whether a biopsy is needed. They may also provide additional information when biopsy results are unclear or do not match the wider clinical picture.
The final determination also allows surveillance testing in patients who do not show clear signs of rejection. This is important because changes in graft health may occur before symptoms become obvious. Earlier molecular insight may help clinicians identify risk sooner and adjust patient management where appropriate.
Coverage is subject to analytical validity, clinical validity and clinical utility requirements. Tests must also complete a MolDx Technical Assessment. These conditions maintain a clear evidence threshold and favour companies able to support their products with strong clinical validation.
Kidney transplant recipients may be tested at up to six timepoints during the first year after transplant. Heart and lung transplant recipients may be tested at up to 12 timepoints during the same period. Testing may continue at a lower frequency after the first year where supported by evidence and clinical guidance.
The LCD also places limits on unnecessary duplication. In most cases, only one molecular test may be used for a patient encounter. Molecular testing and biopsy at the same time are expected to be reserved for limited situations where both are clinically justified.
Verici Dx Plc (LON:VRCI) is developing a complementary suite of proprietary, leading-edge tests forming a kidney transplant diagnostics platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes.
