Bio-Reference Laboratories

What Bio-Reference Laboratories does

BioReference Health is a U.S. clinical diagnostic laboratory and wholly owned subsidiary of OPKO Health (NASDAQ: OPK), founded in 1981 and headquartered in Elmwood Park, New Jersey. The company provides comprehensive laboratory testing services spanning clinical chemistry, hematology, microbiology, molecular diagnostics, and specialty areas including urology (proprietary 4Kscore Test for prostate cancer risk), women's health (non-invasive prenatal screening, cervical cancer screening with CINtec PLUS Cytology), oncology, and genetics. Following a major 2024-2025 restructuring in which OPKO sold the oncology division and select clinical diagnostics assets to Labcorp, BioReference retained approximately $300 million in annual revenue, full laboratory operations in New York and New Jersey, nationwide distribution of the 4Kscore Test, and a renewed focus on specialty and core clinical testing. The company operates 11 laboratory locations, is in-network with the five largest U.S. health plans including UnitedHealthcare's Preferred Laboratory Network, and holds CLIA, CAP, ISO 15189, GxP, HIPAA, and FedRAMP certifications.

BioReference's product portfolio combines proprietary tests (4Kscore, pTau181 for Alzheimer's, OVA1Plus via Aspira partnership), FDA-approved offerings (CINtec PLUS Cytology, MSK-ACCESS liquid biopsy powered by SOPHiA DDM), and self-collection devices (Abbott simpli-COLLECT HPV and STI). The company sells through a multi-channel model: enterprise field sales to hospitals and health systems (e.g., Westchester Medical Center Health Network), provider-referred testing via the InsightDx portal integrating with hundreds of EHR and LIS systems, direct government and employer contracts, and a newly launched direct-to-consumer platform (BioReference Direct, April 2026) that enables consumer-initiated test ordering. The company also operates Clinical Research Services supporting CROs and biopharma with trial laboratory infrastructure, custom assay development, and real-world data projects.

Revenue is generated primarily through test fees billed to insurance companies, Medicare/Medicaid, and patients under per-test pricing governed by payer contracts, with the 4Kscore Test covered by Medicare under a Novitas LCD. Distribution relies on provider orders, patient service centers, health plan network participation, and enterprise health system agreements. Following the divestiture, BioReference has shifted from a national full-service competitor to a focused regional laboratory plus specialty franchise anchored by the 4Kscore Test, with management pursuing DTC expansion and specialty test growth as primary forward levers.

Name

Bio-Reference Laboratories

Legal name

BioReference Health, LLC

Website

https://bioreference.com

Company type

Private

Founded year

1981

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

BioReference Health is an OPKO Health subsidiary providing clinical diagnostic testing with specialization in urology (4Kscore Test), women's health, and core lab services. Following a 2025 Labcorp divestiture, it operates regionally in NY/NJ and launched a direct-to-consumer testing platform in 2026.

Ownership category

akta.pro rank

Product category

Clinical Diagnostic Laboratory Services

NAICS

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

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Clinical diagnostic laboratory
• Specialty laboratory testing
• Molecular diagnostics services
• Genetic laboratory testing
• Clinical research laboratory

Headquarters

HQ city

Elmwood Park

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

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

Revenue model

1. Clinical Laboratory Diagnostic Testing: Core revenue stream from providing comprehensive diagnostic testing services to healthcare providers, clinics, hospitals, employers, and patients. Revenue generated through test fees billed to insurance companies, Medicare/Medicaid, and patients directly.
2. Clinical Research Services: Laboratory services supporting clinical trials for CROs and biopharma companies, including custom assay development, specimen storage and transport, and data management for both early and late-stage trials.
3. 4Kscore Test: Specialty urology test for prostate cancer risk assessment, now a core product focus following restructuring. Generated approximately $300 million in annual revenue from retained operations.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels8 records

Core offering

BioReference Health is a full-service clinical diagnostic laboratory providing comprehensive laboratory testing services across clinical chemistry, hematology, microbiology, molecular diagnostics, and specialty testing in genetics, women's health, oncology, and urology. The company offers a broad test menu to healthcare providers, hospitals, health systems, employers, government agencies, and consumers (via the BioReference Direct digital platform). Proprietary offerings include the 4Kscore Test for prostate cancer risk, CINtec PLUS Cytology for cervical cancer screening, MSK-ACCESS liquid biopsy, pTau181 Alzheimer's biomarker test, and self-collection devices (simpli-COLLECT HPV and STI), supported by CLIA-certified, CAP-accredited, ISO 15189-accredited laboratory operations across 11 U.S. locations.

Product overview

BioReference Health is a comprehensive diagnostic laboratory offering a broad portfolio of clinical testing services organized around specialized divisions. The core offering includes clinical diagnostic testing across multiple disease categories (diabetes, heart disease, sexual health, infectious diseases, cancer). Key branded products and divisions include GenPath Oncology (cancer testing including liquid biopsy), GenPath Urology (featuring the proprietary 4Kscore Test for prostate cancer risk assessment), and GenPath Women's Health (prenatal testing, cervical cancer screening with CINtec PLUS Cytology). The company operates digital platforms including BioReference Direct (consumer-initiated testing), Scarlet Health (patented digital platform), and InsightDx (provider connectivity portal). Recent offerings include COVID-19 and multiplex testing, simpli-COLLECT self-collection devices for HPV and STI testing, and the pTau181 Test for Alzheimer's Disease. The company has divested its oncology division assets to Labcorp while retaining core clinical lab services and 4Kscore testing nationally.

Differentiator

Problem solved

Functional benefit

Brands

• GenPath: Specialty oncology and urology division offering specialized laboratory testing services including the 4Kscore Test for prostate cancer screening.
• 4Kscore
• Scarlet Health
• BioReference Direct

Products and services

• Clinical Diagnostic Testing Services Comprehensive laboratory testing services including clinical chemistry, hematology, microbiology, molecular diagnostics, and specialized testing across multiple disease categories (diabetes, heart disease, sexual health, infectious diseases, cancer). Available to healthcare providers, hospitals, health systems, and through consumer channels.
• 4Kscore Test A proprietary blood test that measures four prostate cancer biomarkers (total PSA, free PSA, intact PSA, and human kallikrein 2) combined with clinical data to calculate a patient's risk of aggressive prostate cancer. FDA-labeled with Medicare LCD coverage from Novitas. Available nationwide.
• BioReference Direct A consumer-initiated diagnostic testing platform that gives consumers direct access to high-quality laboratory testing without physician referral through a fully integrated digital platform with ordering and results access.
• simpli-COLLECT HPV Self-Collection Self-collection device for HPV testing that enables patients to collect samples at home or in clinical settings, improving access to cervical cancer screening. Abbott-powered.
• simpli-COLLECT STI Home Self-Collection Test Self-collection test for sexually transmitted infections allowing patients to collect samples at home for convenient and private testing.
• pTau181 Test for Alzheimer's Disease Blood test for Alzheimer's Disease that measures pTau181 biomarkers to detect Alzheimer's-related amyloid pathology.
• Multiplex COVID-19 and Influenza A/B Test Test that identifies COVID-19 and Influenza A or B infections with a single sample, enabling rapid differential diagnosis and conserving testing supplies.
• CINtec PLUS Cytology Test FDA-approved dual-stain triage test for cervical cancer screenings, offered as a reflex test when cytology is NILM and HPV positive.
• MSK-ACCESS Liquid Biopsy World-class liquid biopsy testing powered by SOPHiA DDM for comprehensive genomic cancer analysis. BioReference was the first laboratory to offer this technology commercially.
• Ova1Plus Blood Tests FDA-cleared blood tests (Ova1 and Overa) distributed through collaboration with Aspira Women's Health to detect risk of ovarian malignancy in women with adnexal masses prior to surgery.
• Clinical Research Services Clinical trial support services working with CROs and biopharma companies, including real-world data projects, specimen storage and transport, custom assay development, and data management for both early and late-stage trials.

Quantifiable outcome

• 24-hour turnaround time for many tests including same-day STAT services and dedicated in-house courier routes
• +4 more outcomes

Named customers8 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

AI capability5 records

Feature9 records

Partnerships

Eleven partnerships are on record, tiered core, major, minor and strategic.

• BioReference Direct Platform LaunchcoreOthers · 30 April 2026BioReference Direct is the company's own digital health platform launched April 2026 to enable direct consumer access to laboratory testing through a fully integrated digital platform
• LabcorpmajorChannel Partner/ Reseller/ Distributor · 15 September 2025Labcorp acquired select assets of BioReference Health including laboratory testing businesses focused on oncology, clinical diagnostics, and reproductive/women's health outside New York and New Jersey. BioReference retains 4Kscore Test and full operation in NY/NJ.
• Mito HealthminorGTM or Marketing Partner · 17 March 2025Mito Health uses BioReference for comprehensive blood testing covering 100+ biomarkers; expanded to all 50 US states through partnership with Labcorp and BioReference
• LabcorpmajorChannel Partner/ Reseller/ Distributor · 11 March 2025Labcorp announced acquisition agreement for select assets of BioReference Health's diagnostics business including clinical laboratory services to extend Labcorp's leadership in oncology and expand access to high-quality clinical laboratory services
• Prognos HealthstrategicStrategic or Co-development Partner · 28 November 2023Strategic collaboration to advance precision medicine and testing using Prognos Health's real-world data capabilities; offers healthcare providers and researchers unique solutions leveraging BioReference testing data
• SOPHiA GENETICSstrategicTechnology or Integration · 7 November 2023BioReference became first laboratory to use MSK-ACCESS powered with SOPHiA DDM, offering world-class liquid biopsy testing commercially across the country through collaboration with Memorial Sloan Kettering Cancer Center technology
• Aspira Women's HealthcoreGTM or Marketing Partner · 5 October 2022Co-marketing and distribution collaboration for OVA1Plus blood tests to detect risk of ovarian malignancy; expanded network of physicians supporting patients nationwide with Aspira's FDA-cleared tests
• Sema4minorChannel Partner/ Reseller/ Distributor · 2 May 2022GeneDx, formerly a BioReference subsidiary, was acquired by Sema4; BioReference continues commitment to genomic testing through remaining operations
• Teal HealthminorGTM or Marketing Partner · 25 January 2022Collaboration supporting cervical cancer awareness month with Teal Health's groundbreaking cervical cancer screening solutions; joint educational and marketing efforts
• Roche (U.S. Ariosa)strategicOEM/ Whitelabel/ Licensing Partner · 16 August 2021BioReference acquired U.S. Ariosa's centralized laboratory prenatal testing business from Roche, expanding non-invasive prenatal screening (NIPS) offerings and enhancing focus on women's health
• Reef TechnologyminorGTM or Marketing Partner · 21 May 2020Partnership to launch pop-up COVID-19 antibody testing sites across the nation starting at Miami International Mall; Reef Technology provided venue and logistics while BioReference provided testing services

Scale indicators11 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• NeoGenomics: Specialty oncology-focused clinical laboratory offering comprehensive cancer testing including liquid biopsy, molecular diagnostics, and pathology services. Closely comparable to BioReference's pre-divestiture GenPath Oncology division and still competitive in retained oncology-adjacent testing.
• Labcorp: Major U.S. clinical laboratory network and the acquirer of BioReference's oncology, clinical diagnostics, and women's health assets. Operates a near-identical full-service clinical lab and specialty testing model and is the most direct competitor and counterparty in the market.
• Natera: Specialty clinical laboratory focused on women's health (non-invasive prenatal screening), oncology liquid biopsy, and urology (including prostate cancer testing). Directly overlaps BioReference's GenPath Women's Health, MSK-ACCESS liquid biopsy, and 4Kscore product lines.
• Quest Diagnostics: Largest U.S. clinical diagnostic laboratory offering a comprehensive test menu to providers, hospitals, and patients with national scale, in-network payer contracts, and specialty testing capabilities. Directly comparable to BioReference's full-service clinical lab model and competing head-to-head in routine diagnostics, women's health, and specialty testing.

Regional players

• ARUP Laboratories: National reference and specialty clinical laboratory affiliated with the University of Utah, offering esoteric and routine testing to hospitals and health systems. Comparable to BioReference's clinical reference testing and specialty diagnostics offerings.
• Sema4 / GeneDx (Sema4 Holdings): Genomic and clinical diagnostics laboratory originally spun out of BioReference (GeneDx). Operates in women's health, reproductive, and rare disease genomics, directly overlapping BioReference's GenPath specialty offerings.

Emerging players

• Guardant Health: Specialty liquid biopsy laboratory offering comprehensive genomic profiling for oncology. Overlaps with BioReference's MSK-ACCESS/SOPHiA DDM liquid biopsy offering in the precision oncology segment and represents a high-growth competitor.
• Invitae (now Labcorp Genetics): Genetic testing laboratory offering hereditary cancer, reproductive health, and clinical genomics services. Comparable to BioReference's GenPath genetics, women's health, and NIPS testing offerings following Roche Ariosa acquisition.

Broad incumbents

• Sonic Healthcare USA: Global diagnostics operator with U.S. clinical laboratory footprint providing routine and specialty testing to providers and health systems. Comparable in offering full-service clinical diagnostics with national reach and similar payer and hospital contracting model.
• Eurofins Clinical Diagnostics (Eurofins Scientific): Global laboratory testing group with U.S. clinical diagnostics operations offering routine and specialty testing. Comparable to BioReference's full-service clinical lab model at the multi-national scale.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/bioreference
• Facebookfacebook.com/Bioreference
• LinkedInlinkedin.com/company/bioreference-laboratories

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Bio-Reference Laboratories