Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its fourth quarter results.

Submitted GraftAssureDx™ for kidney transplant rejection testing for FDA review on Wednesday, March 25.

Looking forward, the FDA guides to a 150-day review process for de novo submissions like ours, and therefore we continue to plan for an FDA-authorized product this year. To note, when the FDA has a question, it can stop the clock relative to its 150-day guidance. Consequently, our teams are working to anticipate and prepare for FDA reviewer questions so that we may respond quickly and remain on track in the review process.

We have made a review-ready submission with sufficient analytical data and clinical evidence to support that our assay is safe and effective for using the fractional measurement of dd-cfDNA to assess the likelihood of transplanted organ rejection.