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Quest Diagnostics

Companion diagnostics

DEVELOPMENT TO COMMERCIALIZATION

Companion diagnostics

We provide services for developing companion diagnostics, including talented experts with decades of experience in project management, data sciences, and quality assurance.
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Assay development and validation

Our CDx team offers expert guidance and support in identifying the ideal companion test tailored to your novel therapeutic. We work in parallel with the drug development to demonstrate feasibility and develop a prototype that precisely meets your needs.

Design control and risk management

All validation is performed under design control. Throughout the diagnostic development process, our quality control and regulatory affairs experts deploy quality practices and procedures to assure that your device meets user needs, intended uses, and specified requirements. 

Regulatory submissions

Our experienced regulatory team supports a broad range of submissions, including 510(k) and Premarket Approval (PMA) application. We engage early and often with regulatory authorities to obtain feedback and ensure alignment of approvals for both the therapeutic drug and the companion diagnostic.

Kit manufacturing

cGMP-compliant diagnostic kit manufacturing and logistics are delivered expertly and efficiently with the highest standards of quality assurance. 

Commercialization readiness

A successful launch starts with broad access and adoption. The platform is chosen to avoid unforeseen commercial barriers to rapid adoption. Our commercial team supports launch with co-developed biomarker education materials and de-identified alerts on biomarker populations.

CDx Development and Validation

Put your CDx in expert hands

For efficient drug–diagnostic codevelopment

Our medical and scientific experts help select the right solution for your clinical use case. The parallel development of a precisely paired CDx can streamline clinical trials and accelerate regulatory approvals optimizing your time to market.

Specimen intake for automation line

We offer a range of diagnostic platform options

We help select the appropriate platform based on your specific diagnostic requirements whether it be to enable the identification of biomarkers, predict treatment response, stratify patients, or help guide personalized treatment strategies.

ELISA

Assess the presence and levels of pre-existing antibodies against AAV vectors for patient suitability, risk assessment, and dosing. 

NGS

Identify genetic variations or mutations that may influence the effectiveness of the therapy or predict the likelihood of response. 

IHC

Determine the presence, absence, or levels of certain proteins to provide insight into biomarker expression patterns.

ISH

Detect and analyze specific nucleic acid sequences to identify gene expression patterns or the presence of genetic alterations.

Operationalization and Commercialization

Facilitate CDx testing at drug launch

Market access with test launch and commercialization support

We have the organizational and logistical resources necessary to provide an end-to-end service for CDx commercialization.

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Ready day 1

Operationalize and commercialize your new companion diagnostic test quickly and efficiently.

Lab readiness

On the very first day of implementation, the performing lab(s) are well-prepared, trained, and equipped to begin performing the new test.

Awareness and education

Co-development and launch of biomarker education materials for provider and patient awareness based on insight from our medical directors.

Sponsored testing

Expedite diagnostic adoption by reducing the financial barriers and burdens on healthcare providers to drive the integration of the test.

Commercial alerts

Schedule timely, deidentified alerts on biomarker populations to support commercial effectiveness to prioritize patient care.

Patient engagement

Engage patients through educational programs, support networks, adherence tools, and clear communications for treatment success.

Mobile specimen collection

Increase reach, accessibility, and convenience for better adoption with patient-centric mobile specimen collection options. Learn more

Info sheet: companion diagnostics

Get an overview of the services and technology we offer, plus additional information about how our team of experts can accelerate your targeted therapy programs.
Download info sheet
Pharma Companion Dx SS

White paper: Read the latest CDx market access report

Learn how charting a clear course for commercialization will help ensure a successful launch of your precision medicine. Choosing the right CDx partner will have you ready for market day 1. 
View our CDx white paper
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CLIA and CAP certified, and ISO17025 and ISO15189 accredited

Let’s discuss your project

Learn how our companion diagnostic development expertise can advance your clinical development program.

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Let's discuss your next project

Connect with our team of experts today.

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Quest® is the brand name used for services offered by Quest Diagnostics Incorporated and its affiliated companies. Quest Diagnostics Incorporated and certain affiliates are CLIA certified laboratories that provide HIPAA covered services.  Other affiliates operated under the Quest® brand, such as Quest Consumer Inc., do not provide HIPAA covered services. 

 

Quest®, Quest Diagnostics®, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks—® and ™—are the property of their respective owners. © 2024 Quest Diagnostics Incorporated. All rights reserved. Image content features models and is intended for illustrative purposes only.