Your Partner in Precision Oncology Development
Your mission is to transform oncology patient care by bringing novel and life-changing therapeutics to market. Our commitment is to help you do it better, faster and more efficiently. Learn more about how Labcorp Oncology can help in your development from asset discovery to diagnostic commercialization.
Oncology Experience You Can Count On
Development of precision oncology therapeutics is complex. Labcorp has the unique ability to support you with testing throughout the entire development, anchored by a biomarker-driven strategy. Efficiencies come through our experience effectively connecting insights from one stage to the next, empowering you to make more informed decisions every step of the way.
We have supported development for:
10 of 16
oncology drugs approved by the FDA in 2022
2,000+
oncology clinical trials across various tumor types over last 5 years alone
6
FDA-approved CAR T-cell therapies
CDx
for PD-L1, HER-2, KRAS, EGFR, BRAF, ALK and more
Specialized Knowledge and Experience at Every Stage of the Cancer Research Continuum
Backed by the broader Labcorp organization and infrastructure, you’ll partner with our dedicated oncology teams focused on every aspect of both therapeutic and diagnostic development – all with one mission: enabling patient access to your critical therapy.
Science & Technology
Scientific teams advancing precision oncology development through innovative technologies for tissue, immune and liquid biopsy profiling.
Operational
A global network of laboratories across all disciplines and committed to driving automation and sample logistics excellence.
Regulatory
Knowledgeable and experienced regulatory leaders who can support your strategy development and discussions with agencies in key global regions.
Data
Expertise analyzing an unparalleled data set to generate meaningful real-world evidence that improve therapeutic and diagnostic development effectiveness.
Medical Affairs
Experienced medical affairs team providing scientific support, education, and exploration of Labcorp Oncology's latest advancements.
Commercialization
Multi-disciplinary team with the focus on accelerating patient access to your biomarker-directed therapy through healthcare provider education.
Integrated Drug and Diagnostic
Capabilities Reduce Timelines and Risks
As the only global research and development organization that can support you from preclinical discovery through diagnostic commercialization, we can help you achieve your milestones faster, maximizing efficiency and preserving knowledge as you advance from one stage to the next.
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Preclinical Development
Rapidly move through preclinical development with comprehensive early development research support
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Preclinical Development
Rapidly move through preclinical development with comprehensive early development research support.
- DMPK/IVP/Discovery
- Bioanalysis
- Preclinical Safety
- Chemistry, Manufacturing & Controls
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Biomarker Discovery & Confirmation
Access scientific leadership and guidance across our extensive global laboratory testing capabilities to extend your translational team and help you define a comprehensive oncology biomarker strategy. Identify and develop fit-for-purpose biomarkers that will inform your clinical development protocol.
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Biomarker Discovery & Confirmation
Access scientific leadership and guidance across our extensive global laboratory testing capabilities to extend your translational team and help you define a comprehensive oncology biomarker strategy. Identify and develop fit-for-purpose biomarkers that will inform your clinical development protocol.
- Customized biomarker solutions from our Biomarker Solution Center
- Using best in-class platform technologies
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Clinical Development Insights
Inform your oncology development strategy to make a more profound a difference in the lives of those living with cancer around the world.
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Clinical Development Insights
Inform your oncology development strategy to make a more profound a difference in the lives of those living with cancer around the world.
- Clinical trial assays for Screening, Inclusion and Stratification
- Endpoint Analysis
- Paired tissue and liquid biopsy strategies for increase patient access
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Companion Diagnostic Development & Commercialization
Efficiently incorporate a potential companion diagnostic into your commercialization strategy and ensure both diagnostic and therapeutic will be ready on day one, maximizing patient access as well as your ROI.
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Companion Diagnostic Development & Commercialization
Efficiently incorporate a potential companion diagnostic into your commercialization strategy and ensure both diagnostic and therapeutic will be ready on day one, maximizing patient access as well as your ROI.
- Global Regulatory Expertise
- Parallel Development of Your CDx and Therapeutic
- US-based Clinical Research Site Partnerships
- Sponsored Testing Support
Unmatched Global Lab Capabilities
Our Global presence means we have a deep understanding of how to navigate regional regulatory guidelines, engage unique patient populations and recruit the top-performing investigation sites from more than 85 countries
Oncology Labs
We have laboratories with oncology capabilities across the globe.
Oncology R&D Testing
We’re driven to deliver with urgency—on time, as expected.
Robust Portfolio of Precision Oncology Solutions
From biomarker discovery to clinical trial assay support and companion diagnostic development and commercialization, Labcorp offers NGS platforms and customized services to help pharmaceutical and biotech companies accelerate innovation, unlock value and bring the promise of precision medicine to more patients.
Liquid Biopsy Profiling Solutions
Comprehensive genomic profiling for biomarker discovery and analysis
Plasma Complete
Identify novel and emerging biomarkers with Plasma Complete, an end-to-end, sample-to-answer liquid biopsy CGP solution for cancer research.
- Genes covered: 521
- Analysis: cfDNA
- Sample input: 25 ng recommended (10 ng minimum)
- Turnaround time: As few as 10 days for prospective analysis; retrospective analysis is dependent upon batch sizing
- Gene list: View full list here
- Matched Normal: Confident classifications with optional paired white blood cell analysis
PGDx Corporate & Lab Certifications:
- ISO 13485:2016
- ISO 15189:2012
- CAP/CLIA
- NY State CLEP
Reliable
Identify somatic mutations with high accuracy and sensitivity even with low DNA input
Comprehensive
Evaluate 521 pan solid tumor-related genes across all variant classes, including SNVs, indels, bTMB, MSI, LOH and select amplifications and translocations
Potential for Expanded Use
Built under design control to withstand the rigors of the FDA approval process for potential use in prospective clinical trials
CAP/CLIA validated assay now available with clinically annotated report
PAN SOLID-TUMOR LIQUID BIOPSY CGP FOR CANCER RESEARCH
OmniSeq INSIGHT ctDNA
Comprehensive biomarker discovery and characterization—even when tumor sample is unavailable. OmniSeq INSIGHT ctDNA provides noninvasive solid tumor profiling with rich variant data and custom reporting options to enable biomarker-driven cancer research.
- Targets covered: 523 genes (full coding sequence), IO gene signatures
- Analysis: ctDNA
- Specimen type: cfDNA derived from blood plasma
- Sample input: As low as 10 ng; 20 ng cfDNA recommended
- Sequencing coverage: >1300x with UMIs
- Turnaround time: As few as 7-10 days
- Gene list: View full list here
- Assesses: DNA full exonic coding, bMSI, bTMB
Comprehensive
Evaluate 523 genes across all variant types, including SNVs, indels, CNAs, fusions/splice variants plus bMSI and bTMB biomarkers
Fast Analysis
Leveraging powerful TSO500 v2 chemistry and DRAGEN servers for rapid, ultra-sensitive analysis
Reliable
98% sequencing QC pass rate
Targeted liquid biopsy test for patient stratification in clinical trials
Plasma Focus
A targeted liquid biopsy test that focuses on FDA-approved and guideline-driven biomarkers for patients with advanced solid cancers, Plasma Focus delivers actionable results to inform cohort stratification and clinical trial enrollment.
- Genes covered: 33
- Analysis: cfDNA
- Sample input: 25 ng recommended
- Sequencing coverage: 25,000x Total Coverage
- Turnaround time: 7-10 days
- Gene list: View full list here
- RUO Service: This targeted assay is also available as a service out of our Baltimore, MD lab.
PGDx Corporate & Lab Certifications:
- ISO 13485:2016
- ISO 15189:2012
- CAP/ CLIA
- NY State CLEP
Sensitive and Specific
Highly sensitive and featuring a highly curated gene panel focused on FDA-approved biomarkers
Fast
Sample collection and processing for results in 7-10 days when rapid results are needed
CDx Ready
Built under design control to withstand the rigors of the FDA approval process
Solid Tissue Profiling Solutions
One comprehensive assay for genomic and immune profiling of solid tumors
OmniSeq® INSIGHT | LDT
Improve biomarker discovery, accelerate timelines and maximize patient stratification with OmniSeq® INSIGHT, a CE-IVD marked comprehensive tissue-based genomic and immune profiling test that is NY State CLEP approved for clinical use and validated under design control to enhance precision cancer therapeutic development.
- Targets covered: 523 for genomic profiling, 395 for immune profiling and PD-L1
- Analysis: DNA, RNA and Proteins
- Specimen type: FFPE tissue
- Sample input: 10 mg tissue or 20x5 μM unstained slides or 40-100 ng DNA and 30-100 ng RNA from FFPE tumor tissue
- Sequencing coverage: 750x
- Turnaround time: 10-14 days
- Assesses: DNA full exonic coding, RNA fusions, mRNA expression, PD-L1 by IHC, HLA Class I genotypes, MSI, TMB, TCRs, TILs, NK, Cancer Testis Antigens
- Gene list: View full list here
OmniSeq Corporate & Lab Certifications:
Comprehensive
Evaluate 523 genes across all variant types, including SNVs, indels, CNAs, fusions/ splice variants including genes associated with homologous recombination repair deficiency genes, MSI, TMB, expression of 64 clinically-validated immune genes and PD-L1 by immunohistochemistry
Accurate
With DNA and RNA sequencing, you can accurately measure gene and transcript abundance, identify known and novel features and ensure optimal coverage in low-quality samples
Flexible
Offering the ability to decouple the assay to best support the needs of your specific program
The first and only FDA-cleared tumor profiling kitted solution
PGDx elio® tissue complete | IVD
Accelerate your biomarker-driven clinical trial and CDx development with PGDx elio® tissue complete, a FDA-cleared, CE-IVD marked, sample-to-answer solution that includes fully automated bioinformatics and dedicated customer support.
- Genes covered: 505
- Specimen type: FFPE tissue
- Sample input: 50 ng minimum (100 ng recommend)
- Sample pass rate: 92.9%
- Turnaround time: 5 days*
- Gene list: View full list here
*From nucleic acid extraction to analytical report. TAT for kitted workflow only.
PGDx Corporate Lab Certifications:
- ISO 13485:2016
- ISO 15189:2012
- CAP/CLIA
- NY State CLEP
Rapid
Receive actionable results in as little as 5* days with only 6 hours of hands-on time
*From nucleic acid and extraction to variable report. TAT for kitted workflow only
Reliable
Identify somatic mutations, including SNVs, indels, MSI, TMB and select amplifications and translocations, with highly sensitivity and specificity
Proven Quality
Built under design control to withstand the rigors of the FDA approval process for use in prospective clinical trials and companion diagnostic development
Global Availability as a Biopharma Service
PGDx elio® tissue complete will be available as a service offering from the Labcorp Geneva, Switzerland and Shanghai, China laboratories in 2024
Range of methods to drive fit-for-purpose insights in biomarker discovery
Whole Transcriptome Sequencing | RUO
- Specimen type: FFPE / PBMC / Blood
- Analysis: RNA
- Key Types of Sequencing:
- Global Transcript Expression
- Differential RNA Expression
- Neoantigen Prediction
- Total RNASeq + Globin and rRNA depletion
- Stranded Total RNASeq
- Stranded mRNA RNASeq
- RNA Exome Capture RNASeq
- Globin + rRNA depletion followed by Stranded mRNA
Whole Exome Sequencing | RUO
- Specimen type: FFPE / PBMC / Blood
- Analysis: DNA
- Key Coverage: ~22,000 Genes
- Performance: Germline 100X, Somatic 250X-500X
Immune Profiling Solutions
Targeted NGS assay for comprehensive immune profiling
OmniSeq Immune Profiling Assay
Decipher heterogeneity of the tumor microenvironment and identify potential biomarkers for immunotherapy with a targeted, CE-IVD marked NGS assay that measures RNA gene expression associated with anti-tumor immune response markers, including leukocyte subsets, antigen presentation, checkpoint pathways and tumor progression.
- Genes covered: 395 immune markers with 64 clinically validated
- Analysis: RNA
- Specimen type: FFPE tissue
- Sample input: 10 ng of RNA
- Turnaround time: 10-14 days
- Assesses: PD-L1, HLA Class 1 Genotypes, T-cell priming/trafficking, T-cell recognition, T-cell infiltration, killing cancer cells and cancer testis antigens
- Gene list: View full list here
OmniSeq Corporate & Lab Certifications
Comprehensive
Simultaneously analyze multiple immune markers and signaling pathways for a more thorough assessment of immune response and immune cell function
Accurate
Identify molecular signatures or immune cell subsets that are predictive of therapeutic outcomes to guide drug development and improve patient stratification
Complementary Bioinformatics Signatures
Custom bioinformatics signatures including Cancer Testis Antigen Burden to measure co-expression of cancer antigens in tumor immune microenvironments, Cell Proliferation to measure overall proliferative capacity of the tumor immune microenvironments, and Tumor Immunogenic Signature to measure overall inflammation of the tumor immune microenvironments.
immune repertoire analysis
TCR β Repertoire Assays (TCRβ-SR) | RUO
Facilitate translational research studies for understanding the complexity of cellular immunology as a predictive biomarker of response to immunotherapies with Labcorp’s TCR β repertoire assays designed to accurately characterize T-cell repertoire and detect T-cell clonal expansion.
- Analysis: RNA + DNA
- Methodology: NGS
- Specimen: FFPE or PBMC
- Sample input: 50 ng to 1 μg
- Key feature: Interrogates 46 functional TRBV genes, 13 TRBJ
genes and 2 TRBC genes of CDR3 region of β chain (available for mouse and human)
OmniSeq Corporate & Lab Certifications
Quality Analysis
Only high-quality and on-target reads are included in the analysis. reports detailed TCRβ sequencing QC metrics along with VDJ rearrangements and secondary analysis of repertoire features.
Actionable
Identify specific T-cell clones, clonal expansions or other immune-related markers that correlate with treatment outcomes to guide drug development and clinical trial design and assessment
Molecular Residual Disease
TUMOR-INFORMED MRD TO SUPPORT TRANSLATIONAL RESEARCH & GLOBAL CLINICAL DEVELOPMENT
Labcorp® Plasma Detect™
Labcorp Plasma Detect™ is a tumor-informed ctDNA assay that uses a standardized whole genome sequencing (WGS) and machine learning workflow to provide highly sensitive and specific detection of molecular residual disease (MRD) in solid tumor malignancies.
- Variants tracked: SNV
- Specimen type: FFPE tissue ; Buffy Coat (PBMCs); Plasma
- Sample input: 200 ng FFPE tissue; 50 ng buffy coat; 10 ng plasma
- Turnaround time: As few as 14 days for landmark time point; as few as 7 days for longitudinal time point
- Assesses: Thousands of patient-specific mutations to create an MRD signature that is tracked over time
High Sensitivity
Gain more insights with a sample sparing, high sensitivity (0.005% tumor content) and specificity 99.4%* approach
Rapid
Standardized tumor-informed workflow with landmark time point results in as few as 14 days
Scalable
Easily scale with a standardized assay workflow and design control that facilitates global implementation
*Alarcon CR, van der Kruijssen DE, Schraa SJ, et al. Cancer Res. 2022;82(12_Suppl):536. doi.org/10.1158/1538-7445.AM2022-536
Accelerate your antibody-drug conjugate (ADC) drug development therapy
Whether you face challenges in toxicity, immunogenicity, off-target effects or more, we can help. Labcorp Biopharma Laboratory Services has supported 87% of the approved ADC therapies on the market and 76% of those currently in advanced clinical trial stages. As your global ADC development partner, we’ll help your treatment candidate progress from discovery to commercialization with proven capabilities in oncology biomarker and companion diagnostics (CDx) co-development.
To date, Labcorp Biopharma Laboratory Services
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Has supported 13 of the 15 (87%) approved ADCs currently on the market
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Is supporting 16 of the 21 (76%) mid- to late-stage clinical trial ADCs currently in development
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Has experience with multiple generations of payloads, including DNA damaging agents, tubulin binders and topoisomerase 1 inhibitors, with newer payload mode of actions
Proprietary Data and Experience to Reduce Risk and Increase Efficiencies
Using >30 billion lab test results across a growing menu ~5,000 assays and a testing database that reaches of ~50% of US population, we empower you with the insights and support you need throughout asset progression to make more informed decisions at critical development milestones:
- Biomarker Discovery
- Identifying unmet patient needs, disease prevalence, treatment patterns and potential treatment outcomes—informing a sounder design for your overall program
- Gathering high-quality data that’s relevant to your product’s cancer target and eventual indication, providing valuable insights that increase the probability of your trial’s success
- Clinical Trial Utilization
- Using real-time clinical and molecular data to screen and match patients to biomarker-targeted clinical trials
- Better understanding site performance through investigator site data spanning a majority of global clinical trials
- Commercial Programs
- Analyzing cohorts specialized by therapeutic indication or exploratory endpoint analysis (e.g., HCP, ICD 10, diagnosis, biomarker status)
- Accelerating testing with greater pipeline visibility, outreach targeting and forecasting
Connected Insights That Work for You
Integrated Teams Deliver Greater Efficiency
Your mission is to transform oncology patient care. Our goal is to help you do it better, faster and more efficiently. Our integrated team of medical, scientific, regulatory and statistical experts constantly looks for ways to share insights to reduce development time and risk, so your product has the best possible chance of changing the lives of patients around the world.
Parallel Development Leads To Day 1 Access
We uniquely offer parallel drug and diagnostic development capabilities so you can efficiently incorporate a potential companion diagnostic into your commercialization strategy. The tandem progression of both therapeutic and diagnostic ensures both will be ready on day 1, maximizing patient access as well as your ROI.
Accelerating Patient Access to Biomarker-Directed Therapies through
Awareness & Education
Leverage Labcorp’s expansive commercialization expertise and capabilities with our multi-disciplinary team offering a comprehensive portfolio and bespoke partnership solutions, including:
- Day 1 Readiness
Operational availability of the diagnostic test to support access to your therapeutic upon approval through Labcorp’s extensive laboratory network
- Biomarker Enriched Data Solutions
Testing acceleration with pipeline visibility, outreach targeting and forecasting enabled by Labcorp’s unique bioinformatics insights
- Lab Alerts
Facilitate awareness and order adaptation of the companion or complementary diagnostic test with retrospective and/or prospective engagements between healthcare providers and Labcorp’s medical affairs team
- Sponsored Testing Programs
Accelerate patient access to your therapy with a customized approach to overcome challenges in diagnostic utilization, healthcare provider education and testing coverage concerns
Contact Us
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