From Single-Site to Global Scale: A Hybrid Future for CDx

The Evolution of CDx Development

The rise of biomarker-driven therapies created a need for more precise diagnostics. As such, CDx have become indispensable for identifying patients likely to respond to a treatment.

Historically, pharmaceutical companies have pursued two main CDx development and regulatory pathways: the single-site pre-market approval (ssPMA) and the distributed in vitro diagnostic (IVD) kit approaches.

The ssPMA model leverages a single laboratory to develop, validate, and perform analytical and clinical validation of the diagnostic test. Because it offers speed, flexibility, and reduced upfront investment, it is particularly valuable in early drug development when therapeutic efficacy is still being established. But its commercial reach is limited since testing is confined to one laboratory, limiting patient access.

By contrast, the distributed IVD kit model is designed for scale. Diagnostic manufacturers develop and validate kits ready for deployment across multiple laboratories worldwide, enabling broad patient access at therapeutic launch. The drawback is the higher cost and longer timelines required to align full IVD development with drug approvals.

Pharmaceutical companies often treated these models as mutually exclusive, yet both have strengths that can be combined to meet today’s market needs.

Pioneering the Future: A Faster, Broader, and Smarter Hybrid Approach

The future of CDx development lies in a hybrid development and deployment model that combines centralized laboratory validation and clinical trial enrolment with decentralized testing at the point of care. By integrating ssPMA speed and IVD scalability, pharma companies can better align diagnostics with drug development timelines while ensuring broad access at launch.

By partnering with diagnostic companies, pharma can start the traditional central lab approach to develop the clinical trial assay (CTA), while the diagnostic partner simultaneously prepares the distributed IVD for decentralized testing. Through comparison or bridging studies, the ssPMA-approved assay can evolve into a globally distributed kit. This ensures alignment with drug development timelines and expands patient access from day one.

A strong example of this hybrid model is the partnership between SOPHiA GENETICS and Myriad Genetics to develop MSK-ACCESS® powered with SOPHiA DDM™ into a CDx test. Combining the strengths of each, the companies will start by developing a CTA and pursuing FDA approval, which will later transition into an IVDR-certified, globally deployed kit via bridging studies.

This unique CDx concept can be implemented across multiple platforms and laboratories, ensuring maximum patient access, including underserved regions. It also illustrates how a hybrid deployment accelerates timelines, increases scalability, and strengthens equity in precision oncology.

What lies ahead?

Precision medicine is in its infancy, but as it continues to grow, so must the strategies to support equitable access to CDx. The traditional pathways for CDx development are no longer fulfilling the scientific, clinical, and commercial needs of the industry. The future depends on collaboration between pharma and diagnostics companies to implement strategies, such as a hybrid approach to CDx, that accelerate innovation, ensure regulatory alignment, and deliver local access at global scale.

As demonstrated by SOPHiA GENETICS and Myriad Genetics, the industry is moving toward smarter, more efficient, and collaborative solutions. Harnessing the strengths of a dual, centralized and decentralized approach allows pharma to combine efficiency, speed, and equity, redefining the future of CDx and expanding the reach of precision oncology worldwide.