Insight Molecular Diagnostics submitted its GraftAssureDx kidney transplant rejection test to the FDA for de novo review, the company said. The digital PCR-based assay measures fractional donor-derived cell-free DNA (dd-cfDNA) to assess the likelihood of transplanted organ rejection. The company initiated a 5,000-patient clinical study in September and expects FDA authorization later this year. Insight Molecular Diagnostics said it plans to expand claims by collecting additional clinical samples, including absolute dd-cfDNA measures and combination scoring. The submission positions GraftAssureDx against a demand for improved rejection monitoring beyond existing clinical indicators. In parallel, the company currently offers GraftAssureCore, a laboratory-developed test reimbursed by CMS and performed in its CLIA-certified Tennessee lab. It also recently reported financial results showing Q4 2025 revenues of $1.1 million and a narrowed net loss, while increasing R&D spending—reflecting the cash and execution demands of late-stage regulatory preparation.