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Companion Diagnostics Development Services

End-to-end expertise to carry you from biomarker signature identification to timely regulatory approval
The development of companion diagnostics carry specific challenges - from assay development and validation, to determining the ideal regulatory pathway, to coordinating CDx timelines with its therapeutic to align parallel approvals. At Precision, we integrate clinical development, biomarker assays, and regulatory strategy to execute efficient companion diagnostic development programs.

Precision provides a breadth of biomarker, assay development, and validation services to support CDx development

With 6 specialty labs across the US and Europe and expertise across all types of biomarker assays, Precision can support diagnostic and CDx development from biomarker discovery through clinical trial assay development, with the potential for full IVD CDx development.

Precision’s instrumentation and capabilities include all major immunohistochemistry (IHC) platforms, multiplex immunofluorescence (mIF), multiple NGS and genomics platforms, immunoassays, and gene therapy immunogenicity. Precision also has redundant instrumentation at multiple labs, allowing for the assessment of site-to-site variability.

Precision’s Diagnostic Development Instruments and Assays Include:

cdx_ihc-and-mif

IHC and mIF

• Leica BOND
• Dako Omnis,
Dako Link 48, Artisan
• Ventana BenchMark
• Akoya PhenoImagerTM HT
• Pathology services

cdx_ngs-and-genomics

NGS and Genomics

• NGS: Illumina, Thermo Fisher
• NanoString
• ddPCR, qPCR
• 10× genomics

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Immunoassays

• NAb/TAb
• ELISpot
• ELISA
• Cytokine profiling
• Flow cytometry up to 31 colors

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Our IVD Regulatory Team provides full lifecycle support for CDx development

One of the most crucial aspects of  bringing a companion diagnostic to market is knowledge of the ideal regulatory pathways to utilize and the timelines associated with each approach. Precision’s IVD Regulatory Team understands global regulatory frameworks, and  simplifies the complex CDx development process with a demonstrated record of success.

200 IVD & CDx
PRESUBMISSIONS
IDEs, ITAs, AND
ANNEX XIV
SUBMISSIONS
250 510(k), SPECIAL 510(k)s,
EUAs, DE NOVOs, PMAs,
PMA SUPPLEMENTS
FOR IVD & CDx
SUBMISSIONS IN THE US

Hear from our Regulatory Team on early CDx strategies

Companion diagnostics (CDx) play a pivotal role in personalized medicine by enabling the identification of patients who are most likely to benefit from a specific therapeutic intervention. This article dscusses strategies for biomarker development and key considerations for early phase studies involving biomarkers for patient selection. 

Read the Article

Explore a selection of the ways PFM can support CDx development, from planning to approval:

Preclinical to Phase 1

Development and Planning
  • Identify biomarker signature
  • Clinical Trial Assay development
  • Identify regulatory pathways
  • Product design considerations

Phase 2

Strategy
  • Strategy: LDT/CTA to CDx
  • IVD clinical trial submissions

Phase 2/3

Preparing for Approval
  • Analytical study designs
  • Regulatory pre-submissions

Phase 3

Timely Approval
  • Ensure timely regulatory approval

Expert insights: assay development to CDx approval

Read peer-reviewed articles authored by our Precision team on best practices in this field.
  • Research Article

    AAPS Recommendations for the Development of Cell Based Anti Viral Vector Neutralizing Antibody Assays 2020

    Download Article
    AAPS Recommendations for the Development of Cell Based Anti Viral Vector Neutralizing Antibody Assays 2020
  • Research Article

    AAPS Evaluation of Cellular Immune Response to Adeno-Associated Virus Based Gene Therapy (2023)

    Download Article
    AAPS Evaluation of Cellular Immune Response to Adeno-Associated Virus Based Gene Therapy (2023)
  • Research Article

    AAPS Evaluation of the Humoral Response to Adeno-Associated Virus Based Gene Therapy Modalities Using Total Antibody Assays (2021)

    Download Article
    AAPS Evaluation of the Humoral Response to Adeno-Associated Virus Based Gene Therapy Modalities Using Total Antibody Assays (2021)
  • Research Article

    The Regulation of Companion Diagnostics A Global Perspective. Ther Innov Regul Sci. 2013

    Download Article
    The Regulation of Companion Diagnostics A Global Perspective. Ther Innov Regul Sci. 2013
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Case study

Gene Therapy AAV NAb CDx Development

Precision worked with CSL Behring to develop and commercialize a CDx for their treatment for hemophilia, Hemgenix

  • Client engaged with PFM to obtain comprehensive support in developing and commercializing a NAb assay for the vector capsid
  • Precision conducted a multi-phase support program which included:
    • PFM labs onboarding and validating the clinical trials assay
    • PFM Regulatory shepherding the assay through the FDA for use as a CDx
    • PFM Market Access examined commercial considerations and verified that the optimal path – direct payment to the lab for the assay by CSL Behring – is likely acceptable
    • PFM Labs and Regulatory took the necessary actions to provide the NAb assay commercially upon approval of the gene therapy