Oncocyte (IMDX) FDA Approvals $5.85 -0.10 (-1.75%) As of 02:09 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesSEC FilingsShort InterestTrendsBuy This Stock Oncocyte's Drug in the FDA Approval ProcessThis 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 3,2026Provided Update Drug: GraftAssureDxAnnounced Date: March 3, 2026Indication: test kit clinical trial for its planned in vitro diagnostic (IVD)AnnouncementInsight 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.AI SummaryIn 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.Read Announcement 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). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Aura Biosciences FDA Events Vor Biopharma FDA Events Inventiva FDA Events Relmada Therapeutics FDA Events BioAge Labs FDA Events Allogene Therapeutics FDA Events Design Therapeutics FDA Events Solid Biosciences FDA Events CytomX Therapeutics FDA Events Aclaris Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:IMDX last updated on 3/4/2026 by MarketBeat.com Staff. 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Provided Update - March 3,2026Provided Update Drug: GraftAssureDxAnnounced Date: March 3, 2026Indication: test kit clinical trial for its planned in vitro diagnostic (IVD)AnnouncementInsight 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.AI SummaryIn 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.Read Announcement
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