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:

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 understand the ideal regulatory pathways to utilize and the timelines associated with each approach. Precision’s IVD Regulatory Team understands global regulatory framework, 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

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