Insight Molecular Diagnostics Inc. ((IMDX)) announced an update on their ongoing clinical study.
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Study Overview: Insight Molecular Diagnostics Inc. (IMDX) is conducting a study titled ‘GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring.’ The study aims to determine if the dd-cfDNA test can effectively assess rejection in kidney transplant recipients, potentially offering a less invasive alternative to traditional graft biopsies.
Intervention/Treatment: The study tests a diagnostic intervention called the donor-derived cell-free DNA (dd-cfDNA) test. This test measures the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA to monitor kidney transplant rejection.
Study Design: This is an observational study with a case-only model and a prospective time perspective. It involves collecting plasma and urine samples from participants to compare dd-cfDNA test results with standard graft biopsies.
Study Timeline: The study began on August 22, 2025, with an estimated start date, and was last updated on August 13, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: The successful validation of the dd-cfDNA test could significantly impact IMDX’s stock performance by positioning the company as a leader in non-invasive transplant monitoring. This development might also influence investor sentiment positively, given the growing demand for innovative diagnostic solutions in the healthcare sector.
The study is currently ongoing, with further details available on the ClinicalTrials portal.