Insight Molecular Diagnostics Files GraftAssureDx For Kidney Transplant Rejection Testing For FDA Review

Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) has submitted its GraftAssureDx test for kidney transplant rejection to the FDA for review on March 25. The company anticipates a 150-day review process for this de novo submission and is preparing to address potential questions from the FDA to stay on track for an authorized product this year. The submission includes analytical data and clinical evidence supporting the assay's safety and effectiveness.