The company completed clinical validation studies and received ISO 13485 certification for its GraftAssureDx molecular diagnostic test.
Insight Molecular Diagnostics Inc has completed several milestones that advance its GraftAssureDx test kit toward US Food and Drug Administration (FDA) submission for kidney transplant rejection testing.
The Nashville-based company finished a three-site reproducibility study at Tampa General Hospital, Mayo Clinic, and Baylor Scott & White Health, collected what it believes are sufficient clinical samples for its submission, and received ISO 13485 certification. The molecular diagnostic test kit is designed to expand access to organ health testing for kidney transplant patients in what the company estimates is a $2 billion-plus addressable market.
The company is working to complete its remaining internal analytical performance studies, with about 340 of approximately 12,000 instrument and assay cycles remaining to support the FDA submission package.
“Our clinical trial sites have now collected the needed number of samples to finalize the clinical trial part for our FDA submission, based on the projected 25% to 30% organ rejection rate, and those results are being gathered at the sites,” says Insight Molecular Diagnostics chief science officer Dr Ekkehard Schuetz in a release. “This combined with the reproducibility study conclusion represents two major milestones.”
Two-Part Submission Process
The in vitro diagnostic (IVD) De Novo submission includes clinical validation studies conducted at clinical trial sites and internal analytical performance studies performed at the company’s Nashville laboratory. Clinical trial site partners continue to collect and test patient samples while performing patient biopsies to confirm assay performance.
The company is working to complete large-scale precision and repeatability studies using its final IVD software combined with finalized Bio-Rad equipment and reagents.
“We feel confident about every IVD work stream that is within our control, and we are very close to executing our submission to the FDA,” says Insight Molecular Diagnostics chief technology officer Johnson Chiang in a release.
Global Manufacturing Preparation
The ISO 13485 certification from independent European auditor TÜV SÜD confirms that Insight Molecular Diagnostics operates under a quality management system aligned with regulatory requirements. The company believes this certification reduces the risk of surprises during FDA review and quality risks for future manufacturing and commercialization.
The certification also enables an IVD submission in the UK, with an IVD-R submission for the European Union planned during 2026.
The GraftAssureDx technology quantifies donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker of transplant rejection. The company’s scientists in Germany and the US have contributed to developing the science that established dd-cfDNA as a biomarker for transplant rejection over the past decade.
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