CareDx's Drug in the FDA Approval Process
This 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.
- Drug:
- AlloSeq HCT
- Announced Date:
- October 6, 2025
- Indication:
- Chimerism testing kit for Hematopoietic Cell Transplantation
Announcement
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.
AI Summary
CareDx, 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
As of now, CareDx (CDNA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, CareDx (CDNA) has reported FDA regulatory activity for AlloSeq HCT.
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."
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 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
This page (NASDAQ:CDNA) was last updated on 10/8/2025 by MarketBeat.com Staff
