Prometheus Laboratories Inc.

What Prometheus Laboratories Inc. does

Prometheus Laboratories Inc. is a privately held specialty clinical laboratory founded in 1995 and headquartered in San Diego, California, focused on diagnostic testing for gastroenterology and hepatology. The company's core technology platform spans proprietary serologic, genetic, pharmacokinetic, and biomarker assays that address the full inflammatory bowel disease (IBD) and liver disorder patient journey — from disease interception (IBD Precis), through therapy selection (Respondr TNF) and precision-guided dosing (PredictrPK), to therapeutic drug monitoring (Anser platform covering infliximab, adalimumab, vedolizumab, ustekinumab, and risankizumab). The Anser platform relies on a proprietary drug-tolerant Homogeneous Mobility Shift Assay (HMSA) validated against WHO standards, enabling simultaneous quantification of drug and anti-drug antibody levels without interference from circulating drug — a methodological advantage over ELISA-based competitors.

The company monetizes through fee-for-service clinical laboratory testing billed to commercial insurance and Medicare (as a participating provider), supplemented by direct patient self-pay and a financial assistance program. Go-to-market is a hybrid enterprise field-sales motion — a dedicated Technical Specialists team engages gastroenterologists, hepatologists, health systems, and integrated delivery networks — combined with a direct-to-patient support layer covering billing navigation, Good Faith Estimates, and patient advocates. Distribution is increasingly bolstered by channel partnerships such as MultiPlan, while co-development alliances with biopharma (e.g., Celltrion) extend the platform's reach into therapeutic franchises. Operations are anchored in a CLIA-certified (05D0917432), CAP-accredited (6805501) facility running more than 1 million tests annually, with the Anser platform alone having processed nearly 480,000 tests for over 220,000 patients across more than 100 published clinical studies.

The customer base is horizontal across U.S. GI and hepatology providers, with no apparent enterprise concentration. Recent strategic activity — including the 2025–2026 launches of IBD Precis, Respondr TNF, Anser RZB, and PredictrPK VDZ/UST, the Celltrion collaboration, and the MultiPlan network agreement — indicates a company expanding its biologic-coverage footprint and channel reach while transitioning from legacy IBD sgi Diagnostic to the next-generation IBD Precis platform. Pipeline activity (MASH Precis, planned for 2026) extends the franchise from IBD into metabolic liver disease, signaling continued product-led expansion within the specialty diagnostics niche.

Name

Prometheus Laboratories Inc.

Legal name

Prometheus Laboratories Inc.

Website

https://www.prometheuslabs.com/

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

251–500 employees

Short description

Prometheus Laboratories is a privately held specialty clinical laboratory in San Diego providing proprietary serologic, genetic, pharmacokinetic, and biomarker diagnostics for gastroenterology and hepatology, serving gastroenterologists, hepatologists, and health systems across the United States.

Ownership category

akta.pro rank

Product category

Specialty Clinical Laboratory Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN)

akta.pro secondary industry

Reference & Esoteric Testing Laboratories (HLAFAMAJ)

Keywords

• Specialty clinical laboratory
• Gastroenterology diagnostics
• Therapeutic drug monitoring
• Inflammatory bowel disease testing
• Liver fibrosis diagnostics

Headquarters

HQ city

San Diego

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. Clinical Laboratory Testing Services: Prometheus generates revenue through providing specialty diagnostic testing services to healthcare providers and patients. The company bills insurance companies and Medicare directly for testing services performed in its CLIA-certified laboratory. As a Medicare participating provider, the company has established relationships with federal healthcare programs in addition to commercial insurers.
2. Patient Self-Pay and Financial Assistance: For uninsured or self-pay patients, Prometheus provides Good Faith Estimates and accepts payment through credit cards, check, or money order. The company also offers a Financial Assistance Program for eligible patients.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Prometheus Laboratories Inc. operates a CLIA-certified specialty clinical laboratory providing proprietary diagnostic testing services for gastroenterology and hepatology. The company offers a portfolio of serologic, genetic, pharmacokinetic, and biomarker-based tests supporting inflammatory bowel disease (IBD) diagnosis, therapy selection, precision-guided dosing, therapeutic drug monitoring, liver fibrosis assessment, and celiac disease evaluation, processing over 1 million tests annually.

Product overview

Prometheus Laboratories is a specialty clinical laboratory providing a comprehensive portfolio of diagnostic testing services for gastroenterology and hepatology conditions, with primary focus on inflammatory bowel disease (IBD) and liver disorders. The company offers a platform-based approach organized across the patient journey: disease interception (IBD Precis, IBD sgi Diagnostic), precision-guided therapy selection (Respondr TNF), therapeutic drug monitoring (Anser platform for IFX, ADA, VDZ, UST, RZB), and precision-guided dosing (PredictrPK platform for IFX, ADA, VDZ, UST). Additional products support IBD management (RiskImmune, TPMT tests, Thiopurine Metabolites), liver fibrosis assessment (FIBRO*Spect HCV/NASH), and celiac disease testing (Celiac Plus, Celiac Genetics, Celiac Serology). The company performs over 1 million tests annually from its CLIA-certified laboratory in San Diego.

Differentiator

Problem solved

Functional benefit

Brands

• Anser: Therapeutic drug monitoring (TDM) platform for biologic therapies including infliximab, adalimumab, vedolizumab, ustekinumab, and risankizumab
• PredictrPK
• Respondr
• IBD Precis
• RiskImmune
• FibroSpect
• Celiac Plus

Products and services

• IBD Precis Next-generation serologic test for inflammatory bowel disease using a nine-antibody panel with proprietary algorithm to identify IBD patterns, differentiate Crohn's disease from ulcerative colitis, assess colonic/ileal involvement, and risk stratify for complications. Demonstrates 80% sensitivity and 79% specificity for IBD rule-out in adults.
• Respondr TNF Pre-therapy test assessing patient pharmacokinetics and genetics to predict likelihood of response to infliximab, adalimumab or their biosimilars before initiating anti-TNF therapy.
• PredictrPK IFX (Infliximab) Precision-guided dosing test for infliximab during induction and maintenance phases, assessing unique pharmacokinetic profiles to guide optimal timing and administration of IFX infusions.
• PredictrPK ADA (Adalimumab) Precision-guided dosing test for adalimumab during maintenance, providing personalized PK dosing guidance and individual drug clearance to optimize ADA therapy.
• PredictrPK VDZ (Vedolizumab) Precision-guided dosing test for vedolizumab during maintenance, personalizing VDZ maintenance dosing by fine-tuning 300mg infusion frequency based on predicted trough levels and patient-specific clearance.
• PredictrPK UST (Ustekinumab) Precision-guided dosing test for ustekinumab, leveraging current dosing, serology and proprietary population-pharmacokinetic Bayesian algorithm to deliver individualized actionable insights for dose optimization.
• Anser Therapeutic Drug Monitoring Platform Therapeutic drug monitoring platform providing simultaneous quantification of drug and anti-drug antibody levels using proprietary drug-tolerant HMSA methods. Tests available for IFX, ADA, VDZ, UST, and RZB, validated against WHO standards.
• RiskImmune Blood-based genetic test identifying variant carriers of HLA-DQA1*05 (rs2097432) associated with 2-fold increased risk of anti-TNF antibody formation and 7-fold increased risk of antibodies to infliximab specifically.
• TPMT Genetics Genetic test genotyping patients to identify TPMT genotypes affecting thiopurine metabolism, aiding in individualizing starting dose to achieve maximum efficacy with minimized toxicity.
• TPMT Enzyme Phenotyping test for TPMT enzyme activity to aid in individualizing thiopurine dosing, achieving maximum efficacy with minimized toxicity.
• Thiopurine Metabolites Test measuring thiopurine metabolite levels to aid in optimization of ongoing thiopurine dosing to achieve and maintain desired clinical response.
• FIBRO*Spect HCV Non-invasive blood test aiding in detection, staging, and monitoring of liver fibrosis severity for hepatitis C patients, providing quantitative fibrosis score to differentiate F0-F1 from F2-F4.
• FIBRO*Spect NASH Non-invasive blood test using a proprietary algorithm based on three clinically relevant biomarkers (TIMP-1, alpha-2-macroglobulin, and hyaluronic acid) to differentiate F0-F2 from F3-F4 liver fibrosis in NASH patients.
• Celiac Plus Combined serologic and genetic celiac test detecting DQ2/DQ8 genes with 95-100% negative predictive value to rule out celiac disease for life, plus relative risk estimates based on genetic makeup.
• Celiac Genetics Genetic test analyzing patient genetic profile for celiac disease risk stratification through DQ2/DQ8 gene detection.
• Celiac Serology Comprehensive serum antibody profile combining five serological markers (DGP IgA, DGP IgG, tTG IgA, EMA IgA, and total serum IgA) as aid in celiac disease diagnosis.

Quantifiable outcome

• 73% of patients who received infusion 4 were still on IFX at week 52 vs. approximately 30% in previous studies
• +10 more outcomes

Named customers4 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

Feature9 records

Partnerships

Two partnerships are on record, tiered core.

• MultiPlancoreChannel Partner/ Reseller/ Distributor · 16 October 2025Prometheus Laboratories announced new agreement with MultiPlan, a healthcare cost management company, expanding patient access to specialized GI testing services. MultiPlan provides network negotiation services connecting providers and payers.
• CelltrioncoreStrategic or Co-development Partner · 25 August 2025Prometheus Laboratories announced collaboration with Celltrion for Anser testing services. Celltrion is a biopharmaceutical company developing biologic therapies, and the collaboration enables Prometheus to provide therapeutic drug monitoring services supporting Celltrion's biologic therapy portfolio.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Quest Diagnostics: Largest US clinical reference laboratory with extensive serology, infectious disease, and esoteric testing menus. Comparable as a CLIA-certified clinical lab operator serving gastroenterologists and other specialty physicians, though Prometheus focuses narrowly on GI/hepatology serology and TDM where Quest lacks a differentiated niche offering.
• Laboratory Corporation of America (Labcorp): Major US clinical and specialty reference lab offering routine diagnostics, esoteric assays, and drug monitoring services. Overlaps with Prometheus in clinical lab services, specialty diagnostics, and therapeutic drug monitoring for gastroenterology, but at much broader scale across many therapeutic areas.
• ARUP Laboratories: University-affiliated national reference laboratory providing esoteric and specialty clinical lab testing across many therapeutic areas. Comparable as a reference/esoteric clinical laboratory with overlapping menu categories in serology, immunology, and TDM that compete in the same GI specialist test orders.
• Sonic Healthcare: International clinical pathology and reference laboratory group with extensive esoteric testing capabilities and a meaningful US specialty lab presence. Comparable as a large clinical lab operator offering reference/esoteric testing but with a much broader geography, test menu, and scale than Prometheus.

Direct peers

• Exact Sciences: Specialty diagnostic company operating Cologuard and Oncotype DX, with a primary care and gastroenterology sales channel that overlaps Prometheus's call point on GI specialists. Highly comparable business model of proprietary LDTs marketed via field specialists and billed through payors in GI disease management.
• Miraca Holdings / Inform Diagnostics: Specialty anatomic and clinical pathology reference lab serving gastroenterologists, dermatologists, and other specialists with biopsy-based and esoteric testing. Closely comparable to Prometheus in serving GI clinicians with reference-lab-style esoteric and specialty diagnostics.
• Eurofins Viracor: Specialty immunology and infectious disease reference lab offering transplant, immunology, and drug monitoring assays. Comparable to Prometheus's Anser TDM franchise in providing drug-tolerant antibody quantification and therapeutic drug monitoring for specialty drug classes.

Emerging players

• Myriad Genetics: Specialty molecular diagnostics company marketing proprietary tests through a dedicated specialty sales force to physicians and payors. Comparable business model of proprietary LDTs, direct specialty physician sales motion, and payor reimbursement-driven economics, though focused on oncology and women's health rather than GI.
• Castle Biosciences: Specialty diagnostic company commercializing proprietary molecular tests through a small specialty sales force into narrowly defined clinical workflows. Comparable go-to-market model of proprietary LDTs marketed to focused specialist audiences with similar reimbursement dynamics, though focused on dermatology and urology.
• Veracyte: Specialty diagnostics company selling proprietary genomic tests into focused clinical workflows in pulmonology, thyroid, and breast cancer. Comparable in operating a proprietary LDT portfolio sold to specialty physicians, with similar RWE-driven adoption and payor engagement strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/prometheuslab
• LinkedInlinkedin.com/company/prometheus-laboratories-inc

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A

Investments1 record

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

Frequently asked questions about Prometheus Laboratories Inc.