What Pangea Laboratory does

Pangea Laboratory LLC is a CLIA-certified and CAP-accredited next-generation sequencing (NGS) and molecular diagnostics laboratory headquartered in Tustin, California, with an additional facility in Irvine. Founded in 2014 by Dr. Larry Jia — who also founded Zymo Research Corp and is credited with discovering the West Nile virus in North America — the company employs 101–250 people and operates as a private LLC. Its core technology stack combines NGS with multi-omics workflows, advanced bioinformatics, and AI/ML analytical tools for applications spanning epigenetics, microbiome analysis, and infectious disease.

The company serves three primary customer segments: clinicians and healthcare providers (oncologists, urologists, gastroenterologists, and primary care physicians) seeking precision diagnostic tests; researchers and academic institutions requiring high-throughput sequencing and validation; and pharmaceutical and diagnostic developers needing CLIA/CAP-grade analytical and clinical validation services. Its product portfolio includes proprietary laboratory developed tests (LDTs) — Bladder CARE™ (urine-based DNA methylation bladder cancer test with FDA Breakthrough Device Designation), iFOB (fecal immunochemical colorectal cancer screening with a reported 3.6%–5.1% false positive rate), and GA-map® MHI GutHealth (microbiome-based diagnostic licensed from Genetic Analysis AS) — alongside a forthcoming PrecisionBIOME™ NGS pathogen and antimicrobial resistance panel scheduled for Q2 2026. Strategic distribution is supported through partnerships with Unilabs (Bladder CARE™) and Gene Solutions (SPOT-MAS and K-4CARE liquid biopsy validation).

Pangea generates revenue through three primary streams: per-test transaction fees for laboratory testing services (CLIA/CAP reference lab work, iFOB, Bladder CARE™), professional services fees for clinical development and validation engagements with pharma and diagnostic developers, and licensing-equivalent economics from partnered LDT distribution. Pricing is quote-based and not publicly disclosed, though iFOB is positioned as substantially less expensive than colonoscopy or multi-target stool DNA alternatives (approximately 22× cheaper than Cologuard®). Go-to-market is primarily B2B enterprise field sales supported by digital marketing (website, LinkedIn, YouTube) and direct quote-based engagement with healthcare systems, hospital networks, and primary care physician groups. The company has no disclosed institutional investors, funding rounds, or revenue figures.

Name

Pangea Laboratory

Legal name

Pangea Laboratory LLC

Website

https://pangealab.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

101–250 employees

Short description

Pangea Laboratory is a CLIA-certified, CAP-accredited next-generation sequencing and molecular diagnostics laboratory that provides clinical development services, reference lab work, and proprietary diagnostic tests to clinicians, researchers, and diagnostic developers.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Genomics & Next-Generation Sequencing (NGS) Services (HLAGANAA)

akta.pro secondary industries

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

Keywords

• Molecular diagnostics services
• Next-generation sequencing
• Clinical laboratory testing
• Cancer screening diagnostics
• Microbiome diagnostic testing

Headquarters

HQ city

Tustin

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Laboratory Testing Services: CLIA/CAP-accredited laboratory providing diagnostic testing services including custom sequencing solutions, reference lab services, and clinical validation testing. Revenue generated from test processing fees.
2. Clinical Development Services: Transforming innovative research into validated, clinically actionable insights through validated NGS-based diagnostics and precision testing for external partners.
3. Diagnostic Products: Offering proprietary diagnostic tests including Bladder CARE™ for bladder cancer detection and iFOB for colorectal cancer screening as laboratory developed tests (LDTs).

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Pangea Laboratory is a CLIA-certified and CAP-accredited Next-Generation Sequencing (NGS) diagnostic laboratory that delivers integrated services spanning custom sequencing solutions, clinical development, reference lab testing, and proprietary diagnostic assays. The company's menu includes Bladder CARE™ (urine-based DNA methylation bladder cancer test with FDA Breakthrough Device Designation), iFOB (fecal immunochemical colorectal cancer screening), GA-map® MHI GutHealth (microbiome-based gut health test), and PrecisionBIOME™ (NGS pathogen and antimicrobial resistance panel — coming Q2 2026). It serves clinicians, researchers, pharma companies, and diagnostic developers across oncology and infectious disease.

Product overview

Pangea Laboratory is a CLIA-certified and CAP-accredited NGS diagnostic laboratory offering an integrated suite of services spanning clinical development, reference lab services, and diagnostic laboratory testing. The company's product portfolio includes proprietary tests: Bladder CARE™ (urine-based DNA methylation bladder cancer test with FDA Breakthrough Device Designation), iFOB (fecal immunochemical test for colorectal cancer screening), GA-map® MHI GutHealth (microbiome-based gut health test in partnership with Genetic Analysis AS), and PrecisionBIOME™ (NGS platform for pathogen detection - coming Q2 2026). The company also provides custom sequencing solutions and serves as a reference laboratory for research and clinical applications.

Differentiator

Problem solved

Functional benefit

Brands

• Bladder CARE: Urine-based DNA methylation test for bladder cancer detection, granted FDA Breakthrough Device Designation
• PrecisionBIOME
• iFOB
• GA-map MHI GutHealth

Products and services

• Clinical Development Services Translates innovative research into validated, clinically actionable insights through validated NGS-based diagnostics and precision testing, all within a CLIA/CAP environment. Targeted at diagnostic developers and pharma partners needing assay development, analytical and clinical validation.
• Reference Lab Services High-throughput, high-quality sequencing and analysis services backed by rigorous quality controls and reproducible standards. Targeted at researchers, academic institutions, and clinicians needing reliable sequencing capacity.
• Diagnostic Laboratory Services Non-invasive diagnostic testing options enabling earlier detection and improved patient outcomes across oncology and infectious disease assays. Targeted at healthcare providers and physicians ordering precision diagnostics.
• Custom Sequencing Solutions Tailored assays and bioinformatics pipelines for R&D and clinical translation. Targeted at diagnostic developers, pharma, and researchers requiring bespoke sequencing workflows.
• Bladder CARE™ Urine-based bladder cancer test that measures methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction. Markedly outperforms traditional cytology. Targeted at urologists, oncologists, and healthcare providers screening/monitoring bladder cancer; has FDA Breakthrough Device Designation.
• iFOB (Immunoassay Fecal Occult Blood) Non-invasive fecal immunochemical test (FIT) for early detection of colorectal cancer through detection of fecal occult blood. False positive rate of 3.6%-5.1% versus 10.2%-13.4% for Cologuard®, with results in 1-3 days. Targeted at primary care physicians, gastroenterologists, and healthcare systems for programmatic CRC screening.
• GA-map® MHI GutHealth Microbiome-based diagnostic test quantifying antibiotic-induced gut microbiome imbalances using the Microbiome Health Index™ (MHI), utilizing 16S rRNA gene sequence analysis with MagPlex® microsphere and Luminex technology. Offered as a Research Use Only (RUO) test. Targeted at clinicians and researchers studying microbiome-related health conditions; results within 72 hours of sample receipt.

Quantifiable outcome

• Over 90% of colorectal cancer patients survive when detected at early stage
• +3 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature6 records

Partnerships

Nine partnerships are on record, tiered flagship, core and minor.

• Gene SolutionsflagshipStrategic or Co-development Partner · 21 January 2026Strategic collaboration to validate AI-driven liquid biopsy assays (SPOT-MAS multi-cancer early detection test and K-4CARE precision oncology assay) for the U.S. market. Pangea conducts analytical and clinical validation at its CLIA/CAP-accredited facility in Irvine, California, while Gene Solutions provides SOPs, funding, and technical support from its CAP-accredited labs in Singapore and Vietnam. Upon successful validation, assays will be offered as Laboratory Developed Tests (LDTs).
• Genetic Analysis AScoreOEM/ Whitelabel/ Licensing PartnerPartnership to launch GA-map® MHI GutHealth in the USA. Pangea Laboratory is the exclusive U.S.-based partner offering this microbiome-based diagnostic test as a Research Use Only (RUO) test. The test quantifies antibiotic-induced gut microbiome imbalances using the Microbiome Health Index™ (MHI).
• UnilabscoreChannel Partner/ Reseller/ DistributorPartnership to introduce Bladder CARE™ Assay, enabling broader distribution of Pangea's proprietary bladder cancer diagnostic test.
• Miller Children's HospitalminorStrategic or Co-development PartnerResearch collaboration on Elexacaftor/Ivacaftor/Tezacaftor effect on microbial density and the microbiome.
• Tuft's UniversityminorStrategic or Co-development PartnerResearch collaboration on human fecal microbiome and resistome after antibiotic treatment.
• Children's Hospital of PittsburghminorStrategic or Co-development PartnerResearch collaboration on pediatric urine microbiome in health and disease.
• Kent State UniversityminorStrategic or Co-development PartnerMultiple research collaborations including skin microbiome studies between healthy and diabetic patients, wound healing case studies, and cross-linked extracellular matrix research.
• Università degli Studi di GenovaminorStrategic or Co-development PartnerResearch collaboration on oral microbiome of periodontal implants.
• University of Southern California Norris Comprehensive Cancer CenterminorStrategic or Co-development PartnerResearch collaboration on diagnostic value of DNA methylation urine test for surveillance of non-muscle invasive bladder cancer.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Tempus Labs: AI-powered precision medicine company combining NGS, molecular profiling, and data analytics for oncology. Comparable to Pangea's AI/ML-driven multi-omics approach and precision oncology positioning, though Tempus operates at substantially larger scale with much greater funding.
• Natera: Public molecular diagnostics company offering cell-free DNA testing across oncology, women's health, and organ health. Comparable to Pangea's molecular diagnostic and NGS-based testing capabilities, particularly in oncology precision medicine applications.
• Guardant Health: Leading liquid biopsy and molecular diagnostics company offering oncology-focused NGS testing. Comparable to Pangea's SPOT-MAS/K-4CARE liquid biopsy validation partnership with Gene Solutions, though Guardant operates at significantly larger scale with established commercial channels.
• NeoGenomics: Clinical cancer genomics laboratory offering oncology testing services including NGS, molecular diagnostics, and clinical trial support. Directly comparable to Pangea's clinical development services, reference lab services, and oncology-focused diagnostic offerings.
• Veracyte: Genomic diagnostics company focused on urologic cancers and other oncology indications, with tests including the Afirma genomic test. Particularly comparable to Pangea's Bladder CARE™ bladder cancer test, as both target urologic cancer diagnostics.
• BioReference Laboratories (Sonic Healthcare): Clinical laboratory offering comprehensive diagnostic testing including molecular diagnostics, genomics, and oncology testing. Comparable to Pangea's CLIA-certified clinical laboratory services and reference lab offerings, though at significantly larger scale.

Direct peers

• Caris Life Sciences: Molecular diagnostics and precision medicine company offering comprehensive tumor profiling, liquid biopsy, and AI-powered analytics. Comparable to Pangea's oncology focus, NGS capabilities, and AI/ML bioinformatics for multi-omics workflows.
• Exact Sciences: Direct competitor in non-invasive cancer screening, particularly with Cologuard® (multi-target stool DNA test for CRC screening) which Pangea's iFOB test directly competes against. Both companies offer stool-based colorectal cancer screening options to healthcare providers.

Emerging players

• BillionToOne: Molecular diagnostics company offering non-invasive prenatal testing and oncology liquid biopsy. Comparable to Pangea's NGS-based diagnostic platform and multi-omics approach, with similar growth-stage characteristics and molecular diagnostics focus.
• Interpace Biosciences: Molecular diagnostics company focused on oncology with proprietary tests for thyroid, pancreatic, and other cancers. Comparable to Pangea's LDT-based molecular diagnostic testing model and oncology-focused proprietary test portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@PangeaLaboratory
• LinkedInlinkedin.com/company/pangealaboratory
• Facebookfacebook.com/thepangealab

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pangea Laboratory