PANGEA LABORATORY SERVICES
Delivering Laboratory Solutions, from Concept to Commercialization
We partner with clinicians and researchers to deliver the scientific rigor, regulatory insight, and operational excellence needed to transform innovative diagnostics into clinical impact.
Our End-to-End Pipeline
From early-stage feasibility to full-scale market launch, our integrated services guide partners through every phase of diagnostic development. Whether you’re validating a biomarker, scaling a clinical test, or launching a breakthrough, we ensure every stage meets the highest integrity and clinical performance standards.
Ideation
A comprehensive onboarding process aligns expectations and establishes secure, we help researchers and developers evaluate whether concepts are scientifically sound, clinically relevant, and commercially viable. Our feasibility studies leverage deep scientific expertise to identify the successful path from innovative idea to actionable diagnostic.
Development
Accelerate test development with end-to-end laboratory and bioinformatics solutions designed to optimize performance and support breakthrough discovery. Our research services help you refine assays, validate biomarkers, and build the evidence base needed to transform vision into reality.
Validation
Ensure your assays meet rigorous clinical standards with comprehensive validation services. We benchmark sensitivity, specificity, and reproducibility within our CLIA/CAP environment, providing the data and regulatory support needed to bring reliable diagnostics to patients.
Commercialization
Scale to market with confidence. We partner with companies through go-to-market strategy, reimbursement navigation, and operational infrastructure that supports high-throughput sample processing, reliable reporting, and scalable workflows—all to ensure your solutions find patients in need.
Pangea's Services
Pangea Laboratory delivers an integrated suite of services spanning clinical development, reference laboratory analysis, and diagnostic testing.
Clinical Development
Reference Lab Services
Diagnostic Lab Services
Clinical Development
Transforming research innovations into validated, clinically actionable diagnostics.
We offer custom assay development and validation services within a CLIA-certified, CAP-accredited environment—supporting pharmaceutical companies, biotech innovators, IVD startups, and academic researchers in bringing breakthrough diagnostics to improve patient health outcomes.
Reference Lab Services
Providing contract and white-label sequencing solutions that scale with your research and clinical needs.
From sample extraction to data reporting, our multiple NGS workflow solutions and platforms deliver the high-quality data and actionable insights researchers and developers need to advance discovery and accelerate innovation.
Diagnostic Laboratory
Delivering clinical diagnostic testing that improves patient outcomes in oncology and infectious diseases.
Our non-invasive testing solutions utilize Pangea’s proprietary assays and FDA-cleared, reimbursable diagnostics to provide clinicians with precise, actionable insights for better patient care.
Accredited for Quality. Trusted for Results.
Pangea Laboratory operates under CLIA certification and CAP accreditation, ensuring precision, consistency, and regulatory compliance across all services. These accreditations reflect our commitment to maintaining the highest standards of analytical performance and patient safety in every test we deliver.
Our Offerings
Custom Sequencing Solutions
Tailored assays and bioinformatics pipelines for R&D and clinical translation.
Bladder CARE™
Urine-based accurate bladder cancer testing made simple.
iFOB
Fecal Occult Blood testing for the early detection of colorectal cancer.
PrecisionBIOME™
Bacterial and fungal identification for clinical and industrial applications.
Coming Soon | Q2 2026
Case Studies
Our partnerships span from early-stage biotech innovators developing next-generation diagnostics to established healthcare organizations expanding their molecular testing capabilities, each supported by Pangea’s end-to-end expertise and accredited infrastructure.
MiDog
High-depth, high throughput Next Generation Sequencing services for animal diagnostic testing with full microbial profiles and actionable insights.
BladderCare™
Urine-based epigenetic assay intended for the semi-quantitative detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC).
Genetic Analysis
Asset validation enabling U.S. market access for advanced gut microbiome health assessment.
Latest News + Insights
Explore how Pangea Laboratory is shaping the future of precision diagnostics, from NGS innovations to clinical assay development.
Partners
Genetic Analysis AS and Pangea Laboratory LLC announces the launch of GA-map® MHI GutHealth in the USA
The GA-map® MHI GutHealth is the first microbiome-based diagnostic test providing clinically actionable insights into antibiotic-induced microbiome imbalances. The test has been developed by GA in collaboration…
Pangea in the News
Pangea Laboratory Appoints John Moore as Chief Executive Officer
Partnerships
Pangea Laboratory Partners with Unilabs to Introduce Bladder CARE™ Assay…
Research
Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay
The Bladder CARE™ Assay measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction. It markedly outperforms traditional cytology…