What Www.gopathdx.com does

GoPath Diagnostics, operating as GoPath Global, Inc., is a privately held, CAP-accredited and CLIA-certified molecular diagnostic laboratory headquartered in a 30,000 sq. ft. facility in Buffalo Grove, Illinois. Founded in 2011 by Dr. Jim Lu and Dr. David Wilson, the company runs a specialty cancer diagnostics platform spanning comprehensive genomic profiling (OncoTarget 500 — an FDA-cleared 505-gene panel), immunotherapy biomarkers (OncoCore 32-gene NGS), liquid biopsy recurrence monitoring (OncoTracking ctDNA/MRD), hereditary germline panels (GeneticsNow, BRCANow, LynchNow, ProstateNow, DiabetesNow), and proprietary biomarker tests (URO-17 bladder cancer test with 100% sensitivity and 96% specificity). Supporting technology includes the cloud-based GoPath Information System provider portal and the DigitCells end-to-end digital pathology platform, with AI-driven spatial pathology image processing delivered through a 2024 partnership with Nucleai.

The business operates three distinct go-to-market motions: enterprise field sales to oncology practices, hospitals, and healthcare systems (offering TC/PC billing, kits, logistics, compliance, and credentialing); direct sales to biopharmaceutical companies for central lab services, companion diagnostics development, and clinical trial support (GoPharma division with named clients including Pfizer, Astellas Pharma, WuXi Biologics, and WuXi AppTec); and direct-to-consumer patient testing for hereditary cancer risk and recurrence monitoring. Revenue is generated through CPT-coded fee-for-service laboratory testing, subscription-style digital pathology and provider portal access, and professional-services contract research for biopharma.

Recent strategic activity centers on menu expansion, regulatory unlocking, and vertical extension: FDA clearance for OncoTarget 500 in 2022, NYSDOH licensure in 2023 enabling nationwide germline compliance, the Nucleai AI partnership and OncoCore launch in 2024, and the 2025 DiabetesNow launch into metabolic disease. Ownership is founder/management-controlled with no disclosed external private equity or venture capital backing in the available source material.

Name

Www.gopathdx.com

Legal name

GoPath Global, Inc.

Website

https://gopathdx.com

Company type

Private

Founded year

2011

Operating status

Operating

Short description

GoPath Diagnostics is a CAP-accredited, CLIA-certified molecular diagnostic laboratory in Buffalo Grove, IL offering FDA-cleared genomic profiling (OncoTarget 500), hereditary cancer panels, liquid biopsy MRD, and proprietary biomarker tests. It serves oncology practices, biopharmaceutical companies, and patients via three distinct go-to-market channels.

Ownership category

akta.pro rank

Product category

Molecular Diagnostic Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI), Molecular Pathology & Tissue Biomarkers (IHC/ISH, digital pathology-linked markers) (HLAAAMAI), Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Pathology Reporting, Synoptic Templates & Cancer Registry Interfaces (HLACAMAJ), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Molecular diagnostic services
• Cancer genomic profiling
• Hereditary cancer testing
• Digital pathology solutions
• Biopharma central laboratory

Headquarters

HQ city

Buffalo Grove

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. Laboratory Diagnostic Testing Services: CAP-accredited, CLIA-certified molecular diagnostic laboratory providing tissue diagnostics, molecular testing, genomic profiling, and digital pathology services. Revenue generated through fee-for-service model with CPT codes for various tests.
2. Digital Pathology Solutions: Cloud-based provider portal and image management systems for pathology services with TC/PC billing models
3. Biopharma Central Lab Services: Contract research services for biopharmaceutical companies including histopathology, molecular pathology, companion diagnostics development, specimen management, and regulatory consulting from preclinical through commercialization

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

GoPath Diagnostics operates a CAP-accredited, CLIA-certified molecular diagnostic laboratory in Buffalo Grove, Illinois, delivering cancer diagnostic services including FDA-cleared comprehensive genomic profiling (OncoTarget 500), hereditary germline genetics panels (GeneticsNow/BRCANow/LynchNow/ProstateNow/DiabetesNow), liquid biopsy recurrence monitoring (OncoTracking), the URO-17 bladder cancer test, and specialized anatomic, hematopathology, GI, and GU pathology services. Tests are reported through the cloud-based GoPath Information System provider portal, with the DigitCells digital pathology platform and AI-driven image processing. The GoPharma division provides central lab, companion diagnostics, and contract research services to biopharmaceutical clients.

Product overview

GoPath Diagnostics is a CAP-accredited, CLIA-certified molecular diagnostic laboratory offering a comprehensive portfolio of cancer diagnostic products and services. The portfolio centers on genomic tumor profiling (OncoTarget 500, OncoCore), hereditary cancer genetics (GeneticsNow, BRCANow, LynchNow, ProstateNow), cancer recurrence monitoring (OncoTracking), and specialized anatomic pathology services (URO-17 bladder cancer test, GI pathology, urological pathology, hematopathology). Services are delivered through the cloud-based GoPath Information System and DigitCells digital pathology platform, with AI-powered image processing through a partnership with Nucleai. The GoPharma division provides contract research and central lab services for biopharma clients. Turnaround times range from 24-72 hours (URO-17) to 7-10 days (OncoTarget 500), with TC/PC billing models and genetic counseling support.

Differentiator

Problem solved

Functional benefit

Products and services

• OncoTarget 500 FDA-cleared comprehensive genomic profiling panel analyzing over 500 genes in advanced solid tumors to detect alterations that drive cancer growth and inform targeted therapy selection, with MSI and TMB and a 7-10 day average turnaround time. Designed for oncologists treating patients with advanced solid tumors.
• OncoCore 32-gene NGS panel for immunotherapy biomarkers including MSI, MMR, and PD-L1 assessment, with fusion variant detection for ALK, BRAF, ROS1, NTRK1/2/3 and other actionable targets; designed for oncologists selecting immunotherapy and targeted therapy regimens, with 3-4 day turnaround.
• OncoTracking Liquid biopsy recurrence monitoring and tumor-informed minimal residual disease (MRD) assay using circulating tumor DNA (ctDNA) to detect signs of cancer recurrence earlier than CT or MRI, enabling proactive treatment adjustments for oncology patients in treatment or remission.
• GeneticsNow Comprehensive Panel Comprehensive 88-gene germline hereditary cancer panel analyzing clinically-relevant genes associated with genetic disorders and hereditary cancer syndromes, with 10-14 day average turnaround; designed for patients with personal or family history of cancer and the providers counseling them.
• BRCANow Next-generation sequencing panel for hereditary breast and ovarian cancer risk assessment, offered as Basic (BRCA1/2 deletion/duplication analysis) or Extended (30-gene panel covering ATM, PALB2, CHEK2, and other cancer susceptibility genes); designed for patients with personal or family history of breast or ovarian cancer.
• LynchNow Cost-effective screening panel for Lynch syndrome detection, available as a 5-gene panel (MLH1, MSH2, MSH6, PMS2, EPCAM) or an Extended 32-gene panel for comprehensive colorectal cancer risk assessment; designed for patients and providers evaluating colorectal and endometrial cancer risk.
• ProstateNow 23-gene germline panel plus Genetic Risk Score predicting prognosis in men with localized prostate cancer, therapeutic response in advanced patients, and cancer risk in unaffected men; includes BRCA1/2, ATM, HOXB13, and other prostate-relevant genes with CPT codes 0475U/81479. NYSDOH-licensed for nationwide germline testing.
• DiabetesNow Comprehensive genetic panel for diabetes diagnosis, classification, and management covering 16 genes associated with MODY, syndromic, neonatal, and mitochondrial monogenic diabetes, with polygenic risk scores for Type 1 and Type 2 diabetes; designed for patients with suspected monogenic diabetes and the providers managing them.
• OncoAssure Prostate Multigene prognostic signature incorporating clinicopathological information (CAPRA) that assesses probability of aggressive prostate cancer in men newly diagnosed or post-radical prostatectomy, using 6 genes (FOXM1, MCM3, MTUS1, TTC21B, ALAS1, PPP2CA); designed for urologists and oncologists managing localized prostate cancer.
• URO-17 Bladder Cancer Test Non-invasive immunocytochemical urine test for bladder cancer detection with 100% sensitivity and 96% specificity, based on a novel biomarker compatible with standard IHC systems and able to detect both high-grade and low-grade bladder cancer; designed for urologists and primary care practices seeking non-invasive bladder cancer screening.
• Hematopathology Services Comprehensive hematopathology services spanning flow cytometry, molecular hematology, immunohistochemistry, cytogenetics, and FISH testing with consultation on bone marrow biopsies and lymphoid tissues under a 5-tests-in-1-lab approach; designed for hematologists and oncologists diagnosing hematologic malignancies.
• Gastrointestinal Pathology Specialized GI and liver pathology services integrating immunohistochemistry with advanced molecular diagnostics, including KRAS/EGFR pathways, GIST mutations, Lynch syndrome screening, MSI-H colon cancer testing, HER2 IHC, and GI pathogen panel; designed for gastroenterologists and oncologists treating colorectal and GI cancers.
• Urological Pathology Genitourinary pathology specializing in classification of renal and urologic neoplasms, including urine cytology, urine FISH, PTEN/ERG testing, CytoSnap FGFR3, prostate and bladder biopsy, and URO-17 biomarker testing; designed for urologists, pathologists, and oncology practices.
• GoPharma & Contract Research Central laboratory services for biopharmaceutical development spanning histopathology, digital pathology, molecular pathology, hematopathology, companion diagnostics (CDx) development, specimen management, and kit design, with regulatory consulting support from preclinical through commercialization; designed for pharmaceutical and biotech sponsors and CROs.
• DigitCells Digital Pathology Platform End-to-end digital pathology digitization platform providing image management system capabilities with AI-driven spatial pathology image processing and global access to digital biobanks; designed for research programs, pharmaceutical studies, and providers adopting digital pathology workflows.
• Genetic Counseling Services Genetic counseling services delivered through a network of licensed professionals to help patients and providers interpret hereditary and germline test results and decide on next steps; supports every hereditary GeneticsNow test.

Quantifiable outcome

• 100% sensitivity and 96% specificity for bladder cancer detection with URO-17 test
• +2 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature10 records

Partnerships

Nine partnerships are on record, tiered core, major and strategic.

• NucleaicoreTechnology or Integration · 1 January 2024AI-powered digital pathology partnership established in 2024. Nucleai provides AI-driven spatial pathology image processing capabilities that enhance GoPath's diagnostic capabilities and pathologists' skills in precision medicine.
• DigitCellscoreTechnology or Integration · 1 January 2022Subsidiary created in 2022 for end-to-end digital pathology digitization. Provides image management system capabilities for GoPath Biopharma's AI-driven spatial pathology image processing.
• NorthShore University HealthSystemcoreStrategic or Co-development Partner · 1 January 2021Strategic partnership formed in 2021 for germline testing services. GoPath launched ProstateNow hereditary germline panel for precision oncology in partnership with NorthShore University HealthSystem.
• GenReqmajorImplementation/ SI/ Consulting PartnerRegulatory consulting partnership with GenReq for clinical trial management and regulatory consulting services. GenReq provides regulatory affairs, clinical research, medical affairs and safety consulting with experience in US, Canada, China and EU markets.
• Duke UniversitystrategicStrategic or Co-development PartnerAcademic research collaboration in genomic tumor profiling. Joint work advancing precision medicine through academic-industry partnership.
• PfizermajorStrategic or Co-development PartnerBiopharmaceutical partner for clinical trial services including central lab support, companion diagnostics development, and specimen management.
• Astellas PharmamajorStrategic or Co-development PartnerBiopharmaceutical partner for drug development support services spanning preclinical through commercialization phases.
• WuXi BiologicsmajorStrategic or Co-development PartnerBiopharmaceutical partner for specimen management, contract research services, and laboratory testing support.
• WuXi AppTecmajorStrategic or Co-development PartnerContract research organization partner for integrated business solutions including laboratory services and testing support.

Scale indicators7 records

Recent moves13 records

Expansion highlights6 records

Direct peers

• Natera: Natera offers oncology molecular residual disease monitoring (Signatera) and hereditary cancer testing, directly comparable to GoPath's OncoTracking MRD and GeneticsNow germline panels.
• NeoGenomics: NeoGenomics is a US-based oncology-focused clinical laboratory offering comprehensive genomic profiling, hematopathology, and CGP services to oncologists and biopharma clients — directly comparable to GoPath's oncology diagnostic, OncoTarget 500, and GoPharma central lab offerings.
• Caris Life Sciences: Caris operates a molecular profiling and AI-driven tissue/血液 profiling platform for oncology, including comprehensive genomic profiling and CDx development. Its MI Profile and AI path competing directly with OncoTarget 500 and GoPath's DigitCells platform.
• Tempus AI: Tempus provides NGS-based molecular profiling, liquid biopsy, and AI-driven clinical reporting in oncology, plus biopharma data services. Highly comparable to GoPath's tumor profiling (OncoTarget 500), MRD (OncoTracking) and AI digital pathology stack.
• Foundation Medicine (a Roche company): Foundation Medicine is the leading FDA-cleared comprehensive genomic profiling provider (FoundationOne CDx) and CDx partner for most major oncology drugs. It is the most directly comparable CGP/CDx competitor to GoPath's OncoTarget 500 and GoPharma central lab services.
• Guardant Health: Guardant Health is a leader in liquid biopsy and oncology CGP (Guardant360) with biopharma CDx partnerships. Directly comparable to GoPath's OncoTracking ctDNA MRD/recurrence monitoring and OncoTarget 500 CGP.
• Myriad Genetics: Myriad Genetics provides hereditary cancer testing (BRACAnalysis, myRisk) and oncology molecular diagnostics — comparable to GoPath's BRCANow, LynchNow, ProstateNow, and GeneticsNow comprehensive germline offering.

Emerging players

• Personalis: Personalis offers tumor profiling (ImmunoID NeXT) and MRD assays for biopharma and clinical customers. Directly comparable to GoPath's OncoTarget 500 and OncoTracking, though with a stronger biopharma R&D footprint than clinical volume.
• Resolution Bioscience (Agilent): Resolution Bioscience (acquired by Agilent) develops NGS-based liquid biopsy and tissue CGP for oncology and CDx partnerships — comparable in technology (NGS ctDNA, CGP panels) to GoPath's OncoCore and OncoTarget 500.

Broad incumbents

• Exact Sciences: Exact Sciences is a larger, publicly traded cancer diagnostics company (Cologuard, Oncotype DX, Thrive) operating broadly in oncology screening and molecular diagnostics — overlapping with GoPath's hereditary cancer and CGP businesses as a broader incumbent.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights8 records

Customer concentration

• Xx.com/GoPathLabs
• YouTubeyoutube.com/channel/UCZ-XO-wFhSi388r1bRGPonQ
• Facebookfacebook.com/gopathlabs
• LinkedInlinkedin.com/company/gopath

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

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 Www.gopathdx.com