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Rely on us to help drive your development

We work on diagnostic trials of every kind - regardless of size, population, setting, stage, or pathway. Let us serve as an extension of your development team to successfully execute on all phases of your medical device and diagnostic trials.

Scientific expertise

We bring a team with a wealth of knowledge and experience to the table

We provide the highest level of service and support to ensure the success of your IVD clinical trial. Our dedicated team of experts include:

    - Principal investigators

    - Program managers

    - Specialized lab staff

    - Quality assurance 

    - Therapeutic pathologists

Side view of two young women working in laboratory with microscope.

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.

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

  • Anatomic pathology 
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow cytometry 
  • Hematology
  • Immunology
  • Infectious diseases
  • Mass spectrometry 
  • Microbiology
  • Molecular genetics
  • Molecular infectious disease
  • and more

 


Study types

  • Prospective studies
  • Feasibility
  • Reproducibility
  • Human factor
  • Method comparison
  • Comparator

IVD development lab-based testing services

We help evaluate the performance of your diagnostic or device to ensure that it meets specified requirements and standards for accuracy, precision, and reliability.

Strategy & support for your regulatory pathways

No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, and assist with regulatory pathways.

Regulatory Pathways

  • IDE (Investigational device exemption)
  • PMA (Premarket approval)
  • 510(k) Premarket notification
  • De Novo 
  • IVDR (In vitro diagnostic regulation)

On-Demand Webinar

IVD Studies: Key questions to ask when selecting a lab partner

Reproducibility Studies for IVD

White paper: Selecting a lab partner for your 510(k) submission

Many IVD manufacturers know Quest Diagnostics as one of their largest customers. In fact, as the largest diagnostic lab in the country, we utilize instrumentation from nearly every IVD company in the market.
Device.

White paper: 4 critical questions IVD manufacturers should ask when selecting a lab testing partner for reproducibility studies

This whitepaper explores 4 critical questions IVD manufacturers should ask when selecting a lab testing partner, along with Quest’s responses. 
MedTech Reproducibility Image

Connect with a MedTech expert

We are passionate about our work and are committed to sharing our expertise to help our clients achieve their scientific goals. Submit your question for a MedTech expert.

Neelam Dhiman, PhD

Director of Science, Molecular Infectious Diseases

Dr Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines, including a clinical microbiology fellowship at Mayo Clinic in Rochester, MN. She is a scientific expert in molecular infectious disease and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis. Dr Dhiman is widely published and serves as a scientific reviewer for multiple scientific journal.
Dr. Dhiman

Regulatory, quality & compliance

We are compliant with regulatory requirements and maintain strict quality control standards to ensure the integrity of your data.

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

Program management

Program manager dedicated to your success 

Our program managers have a deep understanding of the complexities involved in managing scientific programs and aim to deliver with the highest standards.

    - Project planning

    - Resource allocation

    - Risk management

    - Stakeholder engagement

Quest employees at the Clifton, NJ lab

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.

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

  • Anatomic pathology 
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow cytometry 
  • Hematology
  • Immunology
  • Infectious diseases
  • Microbiology
  • Molecular genetics
  • Molecular infectious disease
  • and more

Study types

  • Prospective studies
  • Feasibility
  • Reproducibility
  • Human factor
  • Method comparison
  • Comparator

In vitro diagnostic development lab-based testing services

Support evaluating the performance of your diagnostic or device to ensure that it meets specified requirements and standards for accuracy, precision, and reliability.

Strategy & support for your regulatory pathways

No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, assist with regulatory pathways.

Regulatory Pathways

  • IDE (Investigational device exemption)
  • PMA (Premarket approval)
  • 510(k) Premarket notification
  • De Novo 
  • IVDR (in vitro diagnostic regulation)

Meet our experts

We are passionate about our work and are committed to sharing our expertise to help our clients achieve their scientific goals. 

Dr Vivek Kumar

Immunology

Dr Neelam Dhiman

Immunology

Dr Neelam Dhiman

Immunology

Dr Neelam Dhiman

Immunology


Regulatory, quality & compliance

We are compliant with regulatory requirements and maintain strict quality control standards to ensure the integrity of your data.

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

Facility space

Well-equipped and spacious facilities

We offer a state-of-the-art facility fully equipped with the latest technologies and amenitities to support your needs.

- 140,000 sq ft of lab space

- Centrally located

- Labs in close vacinity

Lab view Clifton Lab

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.

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

  • Anatomic pathology 
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow cytometry 
  • Hematology
  • Immunology
  • Infectious diseases
  • Microbiology
  • Molecular genetics
  • Molecular infectious disease
  • and more

Study types

  • Prospective studies
  • Feasibility
  • Reproducibility
  • Human factor
  • Method comparison
  • Comparator

In vitro diagnostic development lab-based testing services

Support evaluating the performance of your diagnostic or device to ensure that it meets specified requirements and standards for accuracy, precision, and reliability.

Strategy & support for your regulatory pathways

No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, assist with regulatory pathways.

Regulatory Pathways

  • IDE (Investigational device exemption)
  • PMA (Premarket approval)
  • 510(k) Premarket notification
  • De Novo 
  • IVDR (in vitro diagnostic regulation)

Meet our experts

We are passionate about our work and are committed to sharing our expertise to help our clients achieve their scientific goals. 

Dr Vivek Kumar

Immunology

Dr Neelam Dhiman

Immunology

Dr Neelam Dhiman

Immunology


Regulatory, quality & compliance

We are compliant with regulatory requirements and maintain strict quality control standards to ensure the integrity of your data.

Sample management

You can trust your samples are in good hands

We offer a comprehensive sample management system to ensure each sample is handled with the utmost care and precision.

    - Mobile collection

    - Biorepository

    - Remnant samples 

    - Kitting and supply support

Lab workers in Clifton

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.

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

  • Anatomic pathology 
  • Chemistry
  • Coagulation
  • Cytogenetics
  • FISH/ISH/IHC 
  • Flow cytometry 
  • Hematology
  • Immunology
  • Infectious diseases
  • Microbiology
  • Molecular genetics
  • Molecular infectious disease
  • and more

Study types

  • Prospective studies
  • Feasibility
  • Reproducibility
  • Human factor
  • Method comparison
  • Comparator

In vitro diagnostic development lab-based testing services

Support evaluating the performance of your diagnostic or device to ensure that it meets specified requirements and standards for accuracy, precision, and reliability.

Study types

  • Prospective studies
  • Feasibility
  • Reproducibility
  • Human factor
  • Method comparison
  • Comparator

In vitro diagnostic development lab-based testing services

Support evaluating the performance of your diagnostic or device to ensure that it meets specified requirements and standards for accuracy, precision, and reliability.

Strategy & support for your regulatory pathways

No matter your therapeutic area, we can provide regulatory strategies, manage pre-submission meetings with regulatory bodies, assist with regulatory pathways.

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