P300: Advancing Precision Medicine and Drug Development: The Landscape of FDA Approvals for Companion Diagnostics
Poster Presenter
Vihanga Pahalawatta
Director Regulatory Affairs
AbbVie United States
Objectives
To analyze FDA approvals/clearances for companion diagnostics (2021-2026), examining technology trends, sample types, indications, and regulatory processes, highlighting the progress in advancing precision medicine and drug development.
Method
FDA-approved and cleared companion diagnostics from 2021-2026 were analyzed using data from CDRH and CDER public databases. The study evaluated trends in assay technologies, sample types, indications, and regulatory processes.
Results
Devices using polymerase chain reaction (PCR) technology represent the highest number of approved CDx by technology while next generation sequencing (NGS) assays had the highest number of devices approved since 2021. NGS devices are associated with a higher number of approved drugs. In contrast, IHC tests show an almost one-to-one relationship between device and drug approvals. Four new technologies were approved as CDx devices since 2021 of which 3 were for gene therapy products to evaluate anti-AAV antibodies. Since 2021, the most CDx submissions have occurred for devices with an indication in non-small cell lung cancer (NSCLC), with the majority being with a tissue sample type. The non-oncology indications – obesity, hemophilia A, and hemophilia B – are liquid samples. Among 86 CDx indications that were approved between 2021 to 2026, only 11 drugs pursued a liquid-based assay as their primary CDx. Majority of therapeutic products which have multiple CDx with both liquid and tissue sample types chose to develop a tissue-based assay as their primary CDx. Although FDA’s requirement is for drug and device approval at same time, there are many instances where drug and device are not approved together. Factors that may cause non-contemporaneous approval include when FDA requires a CDx as a post marketing commitment, a follow-on CDx, or another approved device or Lab Developed Test may be used until the CDx device is approved. FDA review timelines for supplemental PMAs were shorter than for a new PMA as expected. Review timelines varied from 4-42 months for PMAs, 1-6 months for 510(k), 7-9 months for Humanitarian Device Exemptions and 4-18 months for De Novo 510(k)s.
Conclusion
The analysis shows that from 2021 to 2026, FDA approvals for companion diagnostics (CDx) have expanded in technology and indication scope, with PCR still representing the most approved technology and NGS showing the fastest growth and highest association with approved drugs. The emergence of new technologies, especially related to gene therapy (anti-AAV antibodies), highlights innovation in the field. Most CDx approvals are in oncology, specifically non-small cell lung cancer, using tissue samples. Liquid-based assays remain less common, primarily used for certain non-oncology indications. The preference for tissue-based assays as primary CDx, even when multiple types are available, points to clinical and operational advantages. Not all drug and device approvals are simultaneous; regulatory flexibility allows for staggered approvals due to post-marketing commitments, follow-on CDx, or interim use of other tests. Review timelines differ by submission pathway, with supplemental PMAs processed more quickly than new PMAs. These findings underscore rapid advances in CDx technology, continued importance of oncology indications, and the necessity for regulatory strategies tailored to evolving diagnostic-drug co-development. Additionally, FDA's proposal to reclassify nucleic acid-based test systems for use with corresponding approved oncology therapeutic products could potentially streamline regulatory pathways, reduce premarket burdens, and further accelerate the development and adoption of CDx. This reclassification may encourage broader innovation and access by allowing more flexibility in how these tests are developed, validated, and introduced into clinical practice, ultimately benefiting precision oncology and therapeutic co-development strategies. The evolving FDA review processes and timelines should inform strategic planning for stakeholders seeking to accelerate precision medicine and efficient therapeutic development.
