What Nonagen Bioscience does

Nonagen Bioscience Corporation is a clinical-stage diagnostics company developing the Oncuria multiplex protein immunoassay platform for bladder cancer detection, recurrence monitoring, and treatment response prediction. The company serves urologists and clinics evaluating patients presenting with hematuria (blood in urine), patients under surveillance for prior bladder cancer, and patients with non-muscle invasive bladder cancer being considered for BCG therapy. Headquartered in Irvine, California, Nonagen operates its own CAP-accredited, CLIA-certified clinical laboratory (CLIA 05D2051927, CAP 8862074) where it processes specimens shipped from healthcare providers, supported by California and Rhode Island state certifications.

The Oncuria platform is built on xMAP Luminex multiplex bead-based immunoassay technology, quantifying 10 proprietary protein biomarkers (APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGF) from a single voided urine sample using as little as 150 microliters in under 5 hours. A proprietary multivariate classifier algorithm combines biomarker concentrations and clinical inputs into a single risk score delivered via HIPAA-compliant cloud infrastructure. The marketed suite includes Oncuria-Detect (CPT 0365U) as a diagnostic aid, Oncuria-Monitor (CPT 0366U) for recurrence surveillance, and Oncuria-Predict (CPT 0367U) for BCG therapy response prediction. Pipeline additions include Nexus-Dx (neoadjuvant chemotherapy response) and FibraChek (non-invasive liver fibrosis), the latter licensed from Human Metabolomics Institute in August 2023.

Nonagen commercializes Oncuria as a laboratory-developed test (LDT) processed exclusively in its own lab, generating per-test transaction revenue from ordering healthcare providers. The company secured CMS Medicare payment rates for all three variants effective January 1, 2024, and dedicated CPT PLA codes effective January 1, 2023, establishing reimbursement infrastructure. Commercial scaling is executed through a multiyear, multimillion-dollar agreement with Peregrine Market Access as contract commercialization organization, complemented by direct laboratory services and an exclusive manufacturing partnership with Bio-Techne's R&D Systems unit. International revenue potential exists via the June 2022 CE marking for the European market, and future revenue may be supplemented by the HMI-licensed liver fibrosis franchise.

Name

Nonagen Bioscience

Legal name

Nonagen Bioscience Corporation

Website

https://nonagen.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

Nonagen Bioscience is a clinical-stage diagnostics company that develops the Oncuria multiplex protein immunoassay for bladder cancer detection, monitoring, and BCG therapy response prediction, serving urologists and clinics through its CLIA-certified laboratory and contract commercialization partner.

Ownership category

akta.pro rank

Headquarters

HQ city

Los Angeles

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Diagnostic Testing (LDT): Nonagen offers Oncuria as a laboratory-developed test (LDT) processed in their own CLIA-certified clinical laboratory. Healthcare professionals order the test, collect urine specimens, and ship to Nonagen's lab for processing. Results are reported to the ordering provider. The company has received Medicare payment rates established by CMS effective January 1, 2024 for Oncuria-Detect, Oncuria-Monitor, and Oncuria-Predict tests. CPT Proprietary Laboratory Analyses (PLA) codes have been assigned: Oncuria-Detect 0365U, Oncuria-Monitor 0366U, and Oncuria-Predict 0367U.
2. Licensing Royalties (Liver Fibrosis Test): Through an exclusive licensing agreement with Human Metabolomics Institute, Inc. (HMI), Nonagen has rights to develop and commercialize HMI's liver fibrosis/cancer detection technology in the US market and select countries abroad. This represents a potential future revenue stream through licensing arrangements.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Nonagen Bioscience develops and commercializes the Oncuria suite of urine-based multiplex protein immunoassay tests for bladder cancer detection, monitoring, and BCG therapy response prediction. The company operates its own CLIA-certified, CAP-accredited clinical laboratory in Irvine, California where it processes urine specimens sent by healthcare professionals and reports quantitative diagnostic results. The proprietary test measures 10 protein biomarkers combined into a single risk score using Luminex xMAP technology.

Product overview

Nonagen Bioscience offers the Oncuria suite of urine-based multiplex immunoassay tests for bladder cancer. The core Oncuria platform detects 10 protein biomarkers (APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1, VEGF) using Luminex xMAP technology. The platform comprises three distinct sub-products: Oncuria-Detect (aids in diagnosis for patients with hematuria), Oncuria-Monitor (monitors for tumor recurrence in patients with bladder cancer history), and Oncuria-Predict (predicts BCG therapy response). The tests use proprietary multivariate classifier algorithms within a HIPAA-compliant cloud-based system. Additionally, the company is developing pipeline products including Nexus-Dx for chemotherapy response prediction and FibraChek for liver fibrosis assessment.

Differentiator

Problem solved

Functional benefit

Brands

• Oncuria: First-of-its-kind multiplex protein immunoassay for bladder cancer detection, monitoring, and prediction of BCG therapy response. Includes Oncuria-Detect, Oncuria-Monitor, and Oncuria-Predict variants.
• Nexus-Dx
• FibraChek

Products and services

• Oncuria-Detect In vitro multiplex immunoassay for the quantitative detection of 10 bladder cancer-associated proteins in urine. Intended as an aid in evaluating patients with hematuria or upper urinary tract abnormalities for the presence of urothelial cancer, used in conjunction with cystoscopy. Processed as a laboratory-developed test in Nonagen's CLIA-certified laboratory.
• Oncuria-Monitor In vitro multiplex immunoassay for monitoring tumor recurrence in patients previously diagnosed with bladder cancer, used in conjunction with cystoscopy. Detects the same 10 bladder cancer-associated protein biomarkers and is processed as a laboratory-developed test in Nonagen's CLIA-certified laboratory.
• Oncuria-Predict In vitro multiplex immunoassay for predicting rapid failure (recurrence or persistence) in patients with non-muscle invasive bladder cancer who have had tumor transurethral resection and are beginning intravesical BCG therapy. Uses proprietary multivariate algorithms to assess BCG response. Processed as a laboratory-developed test in Nonagen's CLIA-certified laboratory.

Quantifiable outcome

• 93% sensitivity and 93% specificity for detecting bladder cancer in clinical studies
• +4 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Luminex CorporationminorGTM or Marketing Partner · 28 October 2024CEO Dr. Charles Rosser was invited to present at Luminex's prestigious xMAP Conference in Houston, TX. Presentation covered the genesis and current state of Oncuria tests designed to revolutionize early detection and management of bladder cancer using xMAP technology platform.
• Human Metabolomics Institute, Inc. (HMI)minorOEM/ Whitelabel/ Licensing Partner · 14 August 2023Exclusive licensing agreement for HMI's liver fibrosis/cancer detection technology. Nonagen will seek clinical partners to enable widespread healthcare provider access to a noninvasive liver fibrosis detection test throughout the United States and select countries abroad. With liver disease incidence increasing 50% (NAFLD) and 200% (hepatitis C) over past 2 decades, liver fibrosis is a major unmet clinical need.
• DiaCartacoreStrategic or Co-development Partner · 5 January 2023Successful completion of validation study of Oncuria as a laboratory developed test (LDT). DiaCarta received patient urine samples for testing in its CLIA certified lab in Pleasanton, California. Oncuria demonstrated 93% sensitivity and 93% specificity for detecting bladder cancer with consistent performance across tumor grades and stages.
• Bio-Techne Corporation (R&D Systems brand)coreTechnology or Integration · 12 May 2022Exclusive supply agreement for R&D Systems, a Bio-Techne brand, to manufacture Nonagen's Oncuria bladder cancer diagnostic panel using xMAP Luminex technology. Bio-Techne provides high-quality reagents and over 40 years of immunoassay experience combined with Nonagen's diagnostic expertise to create a multiplex protein-based urine test for early detection, therapy choice, and disease monitoring of bladder cancer.
• Peregrine Market AccesscoreGTM or Marketing Partner · 28 January 2022Multiyear, multimillion dollar agreement for Peregrine Market Access to serve as contract commercialization organization and lead the United States launch of Oncuria. Peregrine's team has experience and expertise navigating novel device launch complexities in the United States with shared passion for improving lives of people with chronic, life-threatening conditions.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Guardant Health: Liquid biopsy company offering blood-based cancer diagnostics including Guardant360 for oncology treatment selection. Comparable business model (LDT-processed molecular diagnostics with Medicare reimbursement) and broader oncology footprint, though different specimen type (blood vs. urine) and clinical use cases.
• Natera: Commercial-stage diagnostics company offering Signatera (tumor-informed MRD test) and other oncology and urology-focused tests. Comparable in LDT business model, direct-to-provider sales motion, and pursuit of Medicare reimbursement, with broader indication portfolio and larger commercial organization.
• Foundation Medicine (Roche): Roche subsidiary offering comprehensive genomic profiling tests (FoundationOne CDx, FoundationOne Liquid CDx) for oncology treatment selection. Comparable as an FDA-approved/CLIA-certified oncology diagnostics laboratory serving urology and oncology practices, with significantly broader test menu and global scale.
• Exact Sciences: Commercial-stage cancer diagnostics company with Cologuard (stool-based colorectal cancer screening) and Oncotype products. Highly comparable business model: LDT-processed cancer screening/monitoring test with Medicare reimbursement, direct-to-provider sales motion, and similar regulatory pathway. Significantly larger scale and broader indication portfolio.
• Cepheid (Danaher): Operates within Danaher's Diagnostics Platform offering the GeneXpert molecular diagnostic systems used in clinical laboratories globally. Competes in the clinical diagnostics instrument and reagent space that Nonagen's lab customers use; broader portfolio but provides a comparison point for CLIA-certified laboratory operations and instrument-based diagnostic workflows.

Direct peers

• Veracyte: Offers Decipher Bladder, a genomic test for bladder cancer treatment decision support. Comparable as a molecular diagnostics company serving urology practices with LDT-processed cancer tests, though using tissue-based rather than urine-based methodology.
• MDxHealth: Direct competitor in urologic cancer diagnostics with SelectMDx, AssureMDx, and Navigator urine-based tests for prostate and bladder cancer detection. Comparable in clinical workflow (urine biomarker tests for urologists), LDT business model, and European/US commercial footprint.
• Nucleix: Direct competitor offering Bladder EpiCheck, a urine-based molecular test for bladder cancer recurrence surveillance. Competes head-to-head with Oncuria-Monitor in the surveillance use case and shares the non-invasive urine-based LDT commercial model.
• Pacific Edge Diagnostics: Direct competitor offering Cxbladder, a urine-based molecular diagnostic for bladder cancer detection and recurrence monitoring. Closest comparable in product category (urine-based bladder cancer test), clinical use case (hematuria evaluation, surveillance), and commercial model (LDT processed in own lab).

Others

• Bio-Techne: Exclusive manufacturing partner for Oncuria via the R&D Systems brand, supplying reagents and immunoassay expertise. While not a direct competitor, Bio-Techne's ProteinSimple and ExoDx franchises overlap adjacently in the protein biomarker diagnostics space and they have an intimate view of Nonagen's commercial trajectory.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/nonagen-bioscience-corporation
• Xx.com/NonagenB

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 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 Nonagen Bioscience