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Companion diagnostics development for IVDs and LDTs

Labcorp is your strategic lab partner in companion diagnostic (CDx) development, offering deep expertise, global reach and a proven track record of success.
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Scientist performing CDx assay for companion diagnostic and in vitro diagnostic development with clinical validation support

Parallel therapeutic and diagnostic development

Companion diagnostics (CDx) are essential tools in precision medicine—enabling targeted therapies, improving patient outcomes and streamlining regulatory pathways. A comprehensive CDx strategy can also reduce development time or therapy development costs. Whether you’re pursuing an in vitro diagnostic (IVD) or laboratory-developed test (LDT), Labcorp supports parallel development of therapeutics and diagnostics with scalable solutions across a broad range of therapeutic areas including:

Oncology

Including biomarkers of response and resistance for immuno-oncology and targeted oncology therapies.

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Cardiovascular and Metabolic Disease

Including biomarkers of diabetes, MASH, cardiovascular and renal disease.

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Neurology

Including biomarkers of neurodegenerative diseases.

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Immunology

Including biomarkers of autoimmune and inflammatory conditions.

Flexible models for CDx development

Path 1: CDx is co-developed in a two-way collaboration

Labcorp provides CDx development services supported by dedicated R&D, regulatory and quality teams at our ISO13485 diagnostic development sites.

Path 2: Clinical trial testing or three-way collaboration

Labcorp provides central laboratory testing services in collaboration with your drug development teams and IVD manufacturer to optimize trial design, ensure quality and process consistency, and facilitate enrollment, site selection and patient access.

Our companion diagnostics capabilities:

With decades of scientific experience and a global infrastructure, Labcorp helps advance your CDx faster and smarter. Our streamlined approach supports CDx development from biomarker discovery to regulatory approval and commercialization so you can reduce risk, accelerate timelines and make sure your therapy reaches the right patients.

PCR, NGS, IHC, genotyping and more: These advanced techniques allow for the precise identification and validation of biomarkers. For example, our next-generation sequencing (NGS) services include both short- and long-read sequencing and comprehensive tumor profiling to detect multiple complex genetic variations simultaneously, helping to match targeted therapies with the right patient population. Similarly, Labcorp CDx experts have experience in the development and validation of FDA-approved IHC assays that can help determine patient eligibility through detection of protein-level biomarkers.

  • Patient stratification: With biomarker data, we can help you identify patients who are most likely to benefit from your therapy, improving the success rate of your clinical trials
  • Site selection: Selecting the most appropriate clinical trial sites can mean greater access to diverse patient populations and reduced logistical challenges. Our global infrastructure means you benefit from an optimized site selection process for your clinical trials
  • Real-time data insights: Continuous monitoring and analysis of trial data allows for timely adjustments and insights, enhancing the overall efficiency and reliability of your clinical trials

  • PMA submissions: To reduce the risk of delays and rejections, we offer deep experience with and support the premarket approval submission process to confirm your diagnostic tests meet stringent FDA requirements
  • Launch readiness: Prepare for a successful market launch with strategic insights and support to meet regulatory and commercialization requirements to increase the likelihood that your CDx will be ready on Day 1, alongside the therapeutic

  • Customized outreach and education: To improve patient access to your targeted therapies, we create tailored outreach and education programs to inform healthcare providers and patients about the benefits and availability of your CDx
  • Broaden patient access: By collaborating on a sponsored testing program, together we can enable access, so that patients who need your therapy can receive it quickly and conveniently

Featured applications

Proven track record in advancing companion diagnostics development

We’ve supported FDA-cleared or FDA-approved CDx devices, including HER-2, KRAS, EGFR, BRAF, and ALK. Our global infrastructure and scientific leadership means your CDx reach the market— sooner and more efficiently. 
Ready to co-develop your diagnostic?

FDA-approved companion diagnostic and CDx assay development with in vitro diagnostic clinical validation and global companion diagnostics services

Flexible models to fit your companion diagnostic development path