CareDx (CDNA) FDA Approvals $20.49 -0.12 (-0.58%) Closing price 04:00 PM EasternExtended Trading$20.16 -0.33 (-1.61%) As of 04:25 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock CareDx's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by CareDx (CDNA). Over the past two years, CareDx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AlloSeq. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. AlloSeq HCT FDA Regulatory Events AlloSeq HCT is a drug developed by CareDx for the following indication: Chimerism testing kit for Hematopoietic Cell Transplantation. 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 - October 6,2025Provided Update Drug: AlloSeq HCTAnnounced Date: October 6, 2025Indication: Chimerism testing kit for Hematopoietic Cell TransplantationAnnouncementCareDx, Inc. announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida.AI SummaryCareDx, Inc., a precision medicine company, announced new innovations and products for the ASHI 2025 Annual Meeting, October 6–10 in Orlando, Florida. CEO John Hanna said these advances highlight the firm’s commitment to high-quality HLA typing diagnostics and strengthening its position as a global transplant solutions leader. At ASHI, CareDx will launch AlloSeq Tx11, a next-generation HLA typing solution with enhanced Class II coverage and key non-HLA markers to improve donor–recipient matching. The company will also preview SCORE 7 Software for scalable QTYPE analysis, offer early access to a rapid, long-read HLA genotyping assay, and present data on a combined QTYPE ABO genotyping assay that achieved 100% concordance in clinical validation. Additionally, CareDx’s AlloSeq Tx and QTYPE products have earned EU IVDR certification, ensuring regulatory compliance and reliability for transplant laboratories across Europe.Read Announcement CareDx FDA Events - Frequently Asked Questions Has CareDx received FDA approval? As of now, CareDx (CDNA) has not received any FDA approvals for its therapy in the last two years. What drugs has CareDx submitted to the FDA? In the past two years, CareDx (CDNA) has reported FDA regulatory activity for AlloSeq HCT. What is the most recent FDA event for CareDx? The most recent FDA-related event for CareDx occurred on October 6, 2025, involving AlloSeq HCT. The update was categorized as "Provided Update," with the company reporting: "CareDx, Inc. announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida." What conditions do CareDx's current drugs treat? Currently, CareDx has one therapy (AlloSeq HCT) targeting the following condition: Chimerism testing kit for Hematopoietic Cell Transplantation. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCelcuity FDA EventsClimb Bio FDA EventsCorvus Pharmaceuticals FDA EventsEditas Medicine FDA EventsEyepoint Pharmaceuticals FDA EventsGenprex FDA EventsGT Biopharma FDA EventsMiNK Therapeutics FDA EventsINmune Bio 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 Veracyte FDA Events Heartflow FDA Events Definium Therapeutics FDA Events Viridian Therapeutics FDA Events Personalis FDA Events Castle Biosciences FDA Events Fulgent Genetics FDA Events Burning Rock Biotech FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:CDNA last updated on 10/6/2025 by MarketBeat.com Staff. 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Provided Update - October 6,2025Provided Update Drug: AlloSeq HCTAnnounced Date: October 6, 2025Indication: Chimerism testing kit for Hematopoietic Cell TransplantationAnnouncementCareDx, Inc. announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida.AI SummaryCareDx, Inc., a precision medicine company, announced new innovations and products for the ASHI 2025 Annual Meeting, October 6–10 in Orlando, Florida. CEO John Hanna said these advances highlight the firm’s commitment to high-quality HLA typing diagnostics and strengthening its position as a global transplant solutions leader. At ASHI, CareDx will launch AlloSeq Tx11, a next-generation HLA typing solution with enhanced Class II coverage and key non-HLA markers to improve donor–recipient matching. The company will also preview SCORE 7 Software for scalable QTYPE analysis, offer early access to a rapid, long-read HLA genotyping assay, and present data on a combined QTYPE ABO genotyping assay that achieved 100% concordance in clinical validation. Additionally, CareDx’s AlloSeq Tx and QTYPE products have earned EU IVDR certification, ensuring regulatory compliance and reliability for transplant laboratories across Europe.Read Announcement
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