Adaptive Biotechnologies' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Adaptive Biotechnologies (ADPT).
Over the past two years, Adaptive Biotechnologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
clonoSEQ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ClonoSEQ FDA Regulatory Timeline and Events
ClonoSEQ is a drug developed by Adaptive Biotechnologies for the following indication: Treatments for patients with lymphoid malignancies.
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:
- clonoSEQ
- Announced Date:
- May 29, 2026
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies Corporation announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 33 presentations, including one plenary session and 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 3 in Chicago, and the European Hematology Association (EHA) Congress, taking place June 11-14 in Stockholm.
AI Summary
Adaptive Biotechnologies said its next-generation sequencing-based clonoSEQ test for measurable residual disease, or MRD, will appear in 33 presentations at two major cancer meetings this year: the ASCO Annual Meeting in Chicago from May 29 to June 3 and the EHA Congress in Stockholm from June 11 to 14. The presentations include one plenary session and 14 oral talks, showing strong interest in the test across blood cancer research.
The company said the new data continue to support clonoSEQ as a leading tool for measuring how well patients respond to treatment, tracking disease over time, and helping guide treatment decisions. At EHA, the findings also add to evidence for highly sensitive MRD testing and show growing international use, especially in Europe. Adaptive said more biopharmaceutical companies are putting MRD into clinical studies and treatment plans. The test can detect one cancer cell in one million healthy cells.
Read Announcement- Drug:
- clonoSEQ
- Announced Date:
- December 6, 2025
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6–9, 2025, in Orlando.
AI Summary
Adaptive Biotechnologies reported growing interventional use of its clonoSEQ test at the 67th ASH Annual Meeting, where 90 abstracts featured clonoSEQ data. Notably, 17 of those abstracts show how next-generation sequencing (NGS) measurable residual disease (MRD) results are directly guiding clinical actions to improve blood cancer care.
Key examples include the phase II EndRAD study, which used NGS MRD to select non–total body irradiation (non‑TBI) transplant conditioning for children and young adults with B‑ALL. Among 51 NGS MRD‑negative patients who received non‑TBI regimens, event‑free and overall survival were excellent and comparable to a TBI cohort, suggesting radiation‑sparing options may be feasible for MRD‑negative patients. Across diseases, investigators presented MRD‑guided strategies in multiple myeloma (32 abstracts), non‑Hodgkin lymphoma (15), chronic lymphocytic leukemia (7) and acute lymphoblastic leukemia (30).
Adaptive says the volume and variety of ASH data underscore clonoSEQ’s growing role in tailoring treatment intensity, duration and surveillance decisions using MRD results.Read Announcement
- Drug:
- clonoSEQ
- Announced Date:
- July 1, 2025
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron's cloud-based Electronic Medical Record (EMR) platform.
AI Summary
Adaptive Biotechnologies has announced that its FDA-cleared clonoSEQ® test for measurable residual disease (MRD) in lymphoid malignancies is now integrated into OncoEMR®, Flatiron Health’s cloud-based electronic medical record platform. This integration allows clinicians at over 1,000 community-based cancer care locations to order and review MRD testing results directly within the platform, simplifying workflows and providing faster access to critical patient data.
The streamlined access to MRD data helps healthcare providers make informed, personalized treatment decisions for blood cancer patients. By incorporating the clonoSEQ® test into OncoEMR®, the collaboration aims to enhance patient care by delivering real-time insights into disease status, making it easier for clinicians in community oncology settings to monitor treatment progress and potentially detect relapses earlier.
Read Announcement- Drug:
- clonoSEQ
- Announced Date:
- May 30, 2025
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan.
AI Summary
Adaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measuring residual disease (MRD) will be highlighted in 30 presentations at major scientific meetings. Of these, 14 are scheduled as oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, running from May 30 to June 3, and at the European Hematology Association (EHA) Congress in Milan, held from June 12 to 15.
The presentations will share new data supporting clonoSEQ's clinical value in managing blood cancers, particularly in multiple myeloma and chronic lymphocytic leukemia. This news underscores the test's growing role in guiding treatment decisions and aiding drug development. By demonstrating its capability to track MRD with precision, clonoSEQ is proving to be a critical tool in advancing precision oncology and improving patient care in lymphoid cancers.
Read Announcement- Drug:
- clonoSEQ
- Announced Date:
- December 7, 2024
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies announced new data demonstrating the impact of measurable residual disease (MRD) assessment using Adaptive's next-generation sequencing-based clonoSEQ® test in blood cancer clinical care and drug development.
AI Summary
Adaptive Biotechnologies recently shared new data on its clonoSEQ® test, a next-generation sequencing diagnostic that measures minimal residual disease (MRD) in blood cancers. The results demonstrate how clonoSEQ can help tailor treatment decisions during patient care and drug development. For example, in mantle cell lymphoma, the test showed that patients in complete remission with undetectable MRD may not benefit from additional intensive treatments like autologous hematopoietic cell transplantation. Other studies presented indicate that achieving a deep molecular remission—MRD levels below 10⁻⁶—correlates with improved outcomes in several blood cancers, such as chronic lymphocytic leukemia, multiple myeloma, and acute lymphoblastic leukemia. This breakthrough research highlights clonoSEQ’s potential to guide physicians in selecting more personalized therapies, minimizing unnecessary treatments, and ultimately improving long-term results for patients with various blood cancers.
Read Announcement- Drug:
- clonoSEQ
- Announced Date:
- December 3, 2024
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies , announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in more than 65 abstracts across eight different types of blood cancer at the 66th Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2024, in San Diego.
AI Summary
Adaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in over 65 abstracts at the 66th Annual American Society of Hematology (ASH) Meeting in San Diego from December 7-10, 2024. This record-breaking number of presentations spans eight different types of blood cancer and includes a plenary session, a late-breaking abstract, and 25 other oral presentations. The clonoSEQ test is widely recognized for its high sensitivity in detecting MRD and plays a key role in both clinical trials and real-world practice. It is used as a primary endpoint in pivotal studies and helps guide treatment decisions, monitor disease progression, and assess patient responses across various blood cancers, thereby advancing precision medicine in hematology.
Read Announcement- Drug:
- clonoSEQ
- Announced Date:
- May 31, 2024
- Indication:
- Treatments for patients with lymphoid malignancies.
Announcement
Adaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually.
AI Summary
Adaptive Biotechnologies announced that its next‐generation sequencing (NGS) based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in multiple oral and poster presentations at two major hematology and oncology meetings. The presentations will take place at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4 and at the European Hematology Association (EHA) Hybrid Congress in Madrid and virtually from June 13 to 16.
The clonoSEQ test, known as the gold standard for MRD measurements, helps clinicians monitor blood cancer patients by predicting outcomes, identifying early relapse, and providing guidance for tailored treatment decisions. The inclusion of clonoSEQ data at these conferences reflects its growing role in both clinical practice and drug development, emphasizing its sensitivity and reliability in managing complex blood cancer therapies.
Read Announcement
Adaptive Biotechnologies FDA Events - Frequently Asked Questions
As of now, Adaptive Biotechnologies (ADPT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Adaptive Biotechnologies (ADPT) has reported FDA regulatory activity for clonoSEQ.
The most recent FDA-related event for Adaptive Biotechnologies occurred on May 29, 2026, involving clonoSEQ. The update was categorized as "Provided Update," with the company reporting: "Adaptive Biotechnologies Corporation announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 33 presentations, including one plenary session and 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 3 in Chicago, and the European Hematology Association (EHA) Congress, taking place June 11-14 in Stockholm."
Currently, Adaptive Biotechnologies has one therapy (clonoSEQ) targeting the following condition: Treatments for patients with lymphoid malignancies..
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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
FDA progress for NASDAQ:ADPT last updated on 5/29/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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