Oncocyte (IMDX) FDA Approvals

Oncocyte's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Oncocyte (IMDX). Over the past two years, Oncocyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GraftAssureDx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

GraftAssureDx FDA Regulatory Events

GraftAssureDx is a drug developed by Oncocyte for the following indication: test kit clinical trial for its planned in vitro diagnostic (IVD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - March 3,2026

• Drug: GraftAssureDx
• Announced Date: March 3, 2026
• Indication: test kit clinical trial for its planned in vitro diagnostic (IVD)

Insight Molecular Diagnostics Inc. announced that in February the company completed several major milestones to support the GraftAssureDx™ test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration (FDA) and also received its ISO 13485 certification.

In February, Insight Molecular Diagnostics announced several major milestones to support the GraftAssureDx test kit and its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration. The company completed a three-site reproducibility study at Tampa General Hospital, Mayo Clinic, and Baylor Scott & White Health. It also said it collected what it believes are sufficient clinical samples to support the statistical analysis needed for the submission.

On Feb. 26, Insight received ISO 13485 certification from TÜV SÜD. That certification confirms a regulator-aligned quality management system, helps enable near-term IVD submissions in the U.K., and paves the way for an EU IVD-R filing. The company says the certification should reduce the risk of surprises during regulatory review and lower quality risk for future manufacturing.

Insight is finishing internal analytical performance testing; of roughly 12,000 instrument and assay cycles needed for the FDA package, about 340 remain. The company aims to make GraftAssureDx available for clinical use beginning in 2026 to expand access to transplant organ health testing.

Oncocyte FDA Events - Frequently Asked Questions

Has Oncocyte received FDA approval?

As of now, Oncocyte (IMDX) has not received any FDA approvals for its therapy in the last two years.

What drugs has Oncocyte submitted to the FDA?

In the past two years, Oncocyte (IMDX) has reported FDA regulatory activity for GraftAssureDx.

What is the most recent FDA event for Oncocyte?

The most recent FDA-related event for Oncocyte occurred on March 3, 2026, involving GraftAssureDx. The update was categorized as "Provided Update," with the company reporting: "Insight Molecular Diagnostics Inc. announced that in February the company completed several major milestones to support the GraftAssureDx™ test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration (FDA) and also received its ISO 13485 certification."

What conditions do Oncocyte's current drugs treat?

Currently, Oncocyte has one therapy (GraftAssureDx) targeting the following condition: test kit clinical trial for its planned in vitro diagnostic (IVD).