Companion Diagnostics: Regulatory and Market Access

The route to companion diagnostic commercialization is complex and must be well-planned to ensure that the test and drug come to market together and with the best possible patient access. At Precision, we understand the intricacies of companion diagnostic development and can help you prepare and integrate regulatory and market access strategies that facilitate market entry and successful uptake of both the test and the associated drug.

Companion Diagnostics: Regulatory and Market Access

The route to companion diagnostic commercialization is complex and must be well-planned to ensure that the test and drug come to market together and with the best possible patient access. At Precision, we understand the intricacies of companion diagnostic development and can help you prepare and integrate regulatory and market access strategies that facilitate market entry and successful uptake of both the test and the associated drug.

Precision companion diagnostic strategies

Integrated, start-to-finish expertise delivers smart solutions at every stage
CDx regulatory strategies

We’ve delivered more than 250 market clearances and approvals along with numerous favorable coverage and payment decisions for hundreds of diagnostic products-including many game-changing, first-to-market innovations.

Our regulatory experts offer comprehensive to-market regulatory and evidence-development strategies, anticipating areas of regulatory risk and monitoring developments in a shifting policy landscape.

Market access and evidence strategies

Our market-savvy experts know how payers think-and how to get them to think the right way about your test. We understand the codes, the fee schedules, the coverage processes, and the evidence that payers need. And, we know the most effective ways to weave them together, so when you go to market you get maximum access in minimum time.

Study design for regulatory and clinical utility

Uniquely, we develop studies to answer the needs of both regulators and payers. Our regulatory and market access experts work together to identify the most impactful clinical and economic endpoints.

Considerations for development and implementation of a companion diagnostic

Case Study: Assay/partner identification and selection, development planning, and risk/benefit analysis

Our client is developing a novel therapeutic directed to patients with certain activating signaling pathway mutations. They needed a partner to support development of a suitable biomarker assay for use as a clinical trial assay (CTA) for multiple indications, and potentially as a companion diagnostic (CDx) for commercial use. Precision executed an integrated commercial/market access and regulatory program that:

  • Performed risk/benefit analysis of strategic options for CTA development, bridging to a commercially-viable CDx offering.
  • Identified and qualified potential assays and partners for CTA and CDx development, and recommended a specific partner and assay for development and commercialization;
  • Prepared a detailed development and go-to-market roadmap driving clinical development planning, including LDT vs. IVD pathways

Contact us to learn about our CDx strategy services >

With drug-diagnostic co-development, firms must ensure priorities, goals align

Courtesy of AIS Health

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostics but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach so they are able to identify the appropriate patient population at launch and get their drug to as many people as possible.

“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval”

Gerald Messerschmidt, MD, FACP
Chief Medical Officer

“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval”

Gerald Messerschmidt, MD, FACP Chief Medical Officer

Tell us about your project requirements

Our companion diagnostics experts are ready to provide guidance on your clinical to commercial development strategy. Start the conversation today.

Tell us about your project requirements

Our companion diagnostics experts are ready to provide guidance on your clinical to commercial development strategy. Start the conversation today.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

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