End-to-end Expertise Informs Our Companion Diagnostic Development Services

Companion diagnostics are becoming increasingly important together with the growth of targeted therapies. At Precision, we integrate clinical development, biomarker assays, regulatory strategy, and commercialization capabilities within a single organization, giving us a unique understanding of what it takes to bring both a targeted therapeutic and its companion diagnostic to market. By focusing on what’s needed for the companion diagnostic to maximize access to the targeted drug, we put together an efficient companion diagnostic development program that positions your product for success.

End-to-end Expertise Informs Our Companion Diagnostic Development Services

Companion diagnostics are becoming increasingly important together with the growth of targeted therapies. At Precision, we integrate clinical development, biomarker assays, regulatory strategy, and commercialization capabilities within a single organization, giving us a unique understanding of what it takes to bring both a targeted therapeutic and its companion diagnostic to market. By focusing on what’s needed for the companion diagnostic to maximize access to the targeted drug, we put together an efficient companion diagnostic development program that positions your product for success.

Precision’s unmatched experience in diagnostic development takes your product from bench to bedside

 

Regulatory strategy & submissions experience
  • 100+ IVD pre-submissions, preclinical/clinical trial designs, and executions
  • 250+ marketing clearances and approvals for IVD submissions
  • 100+ companion diagnostics regulatory filings in countries around the globe

 

Regulatory strategy development & execution

Our regulatory experts offer comprehensive to-market regulatory and evidence development strategies that anticipate areas of regulatory risk. We handle every facet of regulatory approval, from ISO and CLIA certification to authoring FDA, EU and rest-of-world submissions.

 

Pre-submission and marketing clearances

Precision has delivered over 250 proven market clearances and over 100 IVD pre-submissions globally, along with numerous favorable coverage and payment decisions for both diagnostics and companion diagnostics – among which are several game-changing, first-to-market innovations.

Market access and commercialization strategy & support experience
  • 100+ successful diagnostics market access, strategy, and tactical project completions
  • Global experience in 15+ markets on 3 continents

 

Market access, clinical utility, and evidence strategies.

Our team understands and can effectively present the information that payers require – leveraging codes, fee schedules, coverage processes, and evidence – to provide rapid market access for the companion diagnostic.
In addition, Precision leverages our deep understanding of managed markets and extensive drug launch experience to ensure that the CDx strategy optimizes the test’s impact on access to the associated drug. We see the CDx and the targeted therapy as symbiotic partners, which must succeed together for the right therapy to be delivered to the right patient at the right time.

We consider companion diagnostic development from every angle

Precision dives deep to understand and address CDx issues that others overlook

  • What test modality should be used to maximize test and drug access?
  • Is the test modality/biomarker compatible with a kit?
  • What FDA pathway is most favorable for the test?
  • How will the companion diagnostic affect the value to the selected patient population?
  • How will the test result be used to control drug access?
  • What about the impact of competitive tests that weren’t validated with my drug?

Our teams include leaders in the field across every step of development, from biomarker assay development to clinical trial assay to market access, so we know the right questions to ask and how to get the best answers.

Considerations for development and implementation of a companion diagnostic

In this article published in Regulatory Focus, Precision for Medicine IVD and CDx experts discuss how to effectively plan for successful CDx development.

We offer advanced biomarker capabilities

Our specialty labs provide biomarker assay development, validation, and execution services in support of therapeutic and diagnostic development. We excel at assays such as NAb assays for gene therapy CDx development, and in addition to standard biomarker assay platforms, we offer proprietary technologies like ApoStream, for capturing and enriching circulating tumor cells, and Epiontis ID, a scalable alternative to flow cytometry for immunophenotyping.

Our services include:
  • Immune monitoring
  • Genomics
  • Tissue & liquid biopsy
  • Bioanalytical testing

Optimizing successful development of viral vector gene therapies, gene therapy trials, and companion diagnostics

Learn more about companion diagnostics development for gene therapies on pages 10 and 11 of this white paper.

Comprehensive, fully-characterized biospecimens for CDx development

Precision’s biospecimens are a comprehensive selection of biobanked samples and prospective collection services, supporting the needs of virtually any companion diagnostic development program. Within our biorepositories are over 1.5 million biospecimens comprised of unique donor lots with varying demographic profiles, and data from questionnaires such as vital statistics, smoking history, medication, cancer history, travel history, and confirmation of disease status.

Case Study: Enabling life-changing gene therapy through comprehensive support of a rule-out neutralizing antibody CDx

Precision is supporting a client developing a gene therapy treatment for Hemophilia, which is now entering Phase III trials. The therapy is delivered through an AAV vector, but because many serotypes of AAV are endemic in the population, patients may have pre-existing antibodies to AAV, which can impair the efficacy of the treatment. A CDx to detect those antibodies was needed, and Precision was tasked with developing and commercializing a neutralizing antibody (NAb) assay for the vector capsid.

Precision has embarked on a multi-phase support program which includes validating the clinical trial assay, shepherding the assay through the FDA for eventual use as a companion diagnostic, and verifying that the optimal commercial path-direct payment to the lab for the assay by our client-is feasible.

Discover how our companion diagnostic development expertise can advance your clinical development program

Discover how our companion diagnostic development expertise can advance your clinical development program

Services that support companion diagnostics development

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.

Bioanalytical Testing

Bioanalytical analysis of biologics, cell therapies, gene therapies, and companion diagnostics development from the globally-recognized leaders in immunogenicity testing.

Tissue & Liquid Biopsy

Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

Explore other areas of expertise