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Quest Diagnostics

MedTech

Products and services

Medical device and IVD studies demand a shared commitment

We have proven expertise critical to the successful development, validation, and commercialization of in vitro diagnostics and share your commitment to scientific rigor, patient safety, and regulatory compliance. 
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Lab technician scanning a test tube label while conducting a blood test

Lab expertise

World class scientific leaders and program engagement

-  Principle investigator

-  Program Manager

-  Pathology experts

-  LM

 

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From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Assay development
Data services
Patient services
Mobile clinical services
Sponsored testing
Global network

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Facilities available

Industry leading facilities

Open-floor and flexible lab facilities
        -  140,000 square feet available
        -  Centrally located
        -  Labs available in close vicinity

X# of labs operating X# of platforms and more than X# instruments
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From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Assay development
Data services
Patient services
Mobile clinical services
Sponsored testing
Global network

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Sample management

High-quality sample collection and processing services

-  Mobile specimen collection
-  Biorepository/sample storage
-  Remnant samples available
-  Kitting operations
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An image of a laboratory professional holding a test tube filled with blood.

From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Assay development
Data services
Patient services
Mobile clinical services
Sponsored testing
Global network

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

Predicate devices

Access to a broad array of predicate devices

High volumes of positive and negative controls
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From analytical validation through commercialization

Our team understands the unique requirements and needs of an FIM/feasibility, pivotal or post-market study and have experience managing studies across all therapeutic areas and phases.

Assay development
Data services
Patient services
Mobile clinical services
Sponsored testing
Global network

Full-service labs with routine and esoteric testing, broad testing menus

  • Anatomic Pathology (PP)
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow Cytometry 
  • Hematology
  • Immunology
  • Infectious Diseases
  • Microbiology
  • Molecular Genetics
  • Molecular Infectious Disease
  • and more

We ask the right questions along the way:

  • What test modality should be used to maximize test and drug access?
  • What FDA pathway is most favorable for the test?
  • Does the test modality/biomarker align with a commercialization strategy?
  • How will the test result be used to control drug access? (cutoff)
  • What about the turnaround time, sample type, access?
  • Are you planning on bridging studies or doing a co-development?
  • What parameters are needed for a validated assay?
  • Do you need a companion diagnostic? Or a complementary diagnostic? Or a laboratory developed test (LDT)?

Our team can help you determine key elements of your development process:

  • Defining the biomarker (eg, specific variants, proteins, antibodies)
  • Selecting the biomarker analyte (eg, DNA, RNA, protein, IgG)   
  • Selecting the specimen type (eg, serum, saliva, tissue)
  • Selecting the technology (eg, next generation sequencing (NGS), polymerase chain reaction (PCR), immunohistorychemistry (IHC), enzyme-linked immunoassay (ELISA))
  • Selecting the cutoff (eg, number)

Our team can help you determine key elements of your development process:

  • Defining the biomarker (eg, specific variants, proteins, antibodies)
  • Selecting the biomarker analyte (eg, DNA, RNA, protein, IgG)   
  • Selecting the specimen type (eg, serum, saliva, tissue)
  • Selecting the technology (eg, next generation sequencing (NGS), polymerase chain reaction (PCR), immunohistorychemistry (IHC), enzyme-linked immunoassay (ELISA))
  • Selecting the cutoff (eg, number)

We ask the right questions along the way:

  • What test modality should be used to maximize test and drug access?
  • What FDA pathway is most favorable for the test?
  • Does the test modality/biomarker align with a commercialization strategy?
  • How will the test result be used to control drug access? (cutoff)
  • What about the turnaround time, sample type, access?
  • Are you planning on bridging studies or doing a co-development?
  • What parameters are needed for a validated assay?
  • Do you need a companion diagnostic? Or a complementary diagnostic? Or a laboratory developed test (LDT)?

Let's discuss your project

Contact our pharma solutions experts to design a custom program to accommodate the needs of your study.

Let's talk

Let's discuss your next project

Connect with our team of experts today.

Let's talk

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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. © 2025 Quest Diagnostics Incorporated. All rights reserved. Image content features models and is intended for illustrative purposes only.