Proteomedix
Proteomedix AG is a Swiss diagnostics company that develops and commercializes Proclarix, a CE-IVD blood-based biomarker test for clinically significant prostate cancer, serving urologists and diagnostic laboratories across Europe and via an exclusive U.S. license to Labcorp.
- Company typePrivate
- Founded2010
- HeadquartersSchlieren, Switzerland
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Proteomedix does
Proteomedix AG is a Swiss diagnostics company founded in 2010 as an ETH Zurich spin-off, focused exclusively on prostate cancer diagnosis. Its lead product, Proclarix®, is a CE-IVD certified blood-based protein biomarker test that combines two quantitative ELISA assays measuring thrombospondin 1 (THBS1) and cathepsin D (CTSD) with a proprietary risk score algorithm integrating patient age, total PSA, and free PSA. The test is designed for men in the diagnostic 'grey zone' (PSA 2-10 ng/mL), where standard PSA testing produces inconclusive results and over 50% of biopsies are negative or clinically insignificant. Proclarix delivers 90% sensitivity, 95% negative predictive value, and 43% specificity (vs. 18% for %fPSA), reducing unnecessary biopsies by an estimated 22-41%.
The company operates a multi-channel commercialization model: direct European sales to clinical diagnostic laboratories via instrument-reagent pairings with Dynex Technologies; an exclusive U.S. license to Labcorp for development of a laboratory developed test; and co-development agreements with Zhengzhou University Henan Cancer Hospital for Chinese market validation. Proclarix is included in both the 2023 EAU and 2023 AUA/SUO clinical practice guidelines, holds patents across the U.S., Europe, China, Japan, and South Korea, and is manufactured under ISO 13485 quality systems. Additional revenue is generated through a 2025 licensing agreement with Immunovia AB covering manufacturing IP for three pancreatic cancer biomarkers (PancreaSure), yielding $700,000 in milestone payments plus a 3% royalty on net sales through 2032.
Proteomedix was acquired in December 2023 by NASDAQ-listed Blue Water Biotech Inc., with the merged entity rebranded as Onconetix Inc. (NASDAQ: ONCO). Proteomedix operates as a wholly-owned Swiss subsidiary, retaining its lean team of 1-10 staff and Zurich-Schlieren headquarters at the Bio-Technopark. Following the acquisition, the company combines Proclarix with Entadfi (BPH treatment) within the Onconetix men's health portfolio. Founders Ralph Schiess and Christian Brühlmann continue in leadership and scientific advisory roles.
Proteomedix firmographics
Firmographics- Name
- Proteomedix
- Legal name
- Proteomedix AG
- Website
- https://proteomedix.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Proteomedix AG is a Swiss diagnostics company that develops and commercializes Proclarix, a CE-IVD blood-based biomarker test for clinically significant prostate cancer, serving urologists and diagnostic laboratories across Europe and via an exclusive U.S. license to Labcorp.
- Ownership category
- akta.pro rank
Proteomedix industry classification
Industry- Product category
- Prostate Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
- akta.pro secondary industries
- Proteomics & Mass Spectrometry Services (HLAGANAB), Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA)
Keywords
Where Proteomedix is headquartered
LocationHeadquarters
- HQ city
- Schlieren
- HQ country
- Switzerland
- HQ region
- Europe
Offices1 record
Markets served
Proteomedix business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Test Sales: Proclarix is sold to diagnostic laboratories across Europe. Laboratories perform the test using their own infrastructure with Proclarix reagent kits, generating recurring revenue per test performed. Tests are ordered by urologists and physicians for patients with elevated PSA (2-10 ng/ml) to assess risk of clinically significant prostate cancer.
- Licensing Royalties (Immunovia): Licensed manufacturing IP for key reagents to Immunovia for their PancreaSure pancreatic cancer test. Received $700,000 in payments in 2025-2026 plus 3% royalty on net sales from 2026-2032.
- Labcorp U.S. License: Exclusive license granted to Labcorp for U.S. development and commercialization of Proclarix. Terms include upfront payments, development milestones, and commercialization royalties (specific financial terms not disclosed).
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Proclarix laboratory test - price determined by individual laboratories |
Go-to-market motion4 records
Distribution channels4 records
Marketing channels6 records
Proteomedix product offering
Product offeringCore offering
Proteomedix develops and commercializes Proclarix, a CE-IVD certified blood-based diagnostic test for prostate cancer. The test combines two quantitative ELISA assays measuring THBS1 and CTSD biomarkers with a proprietary risk score algorithm, designed to identify clinically significant prostate cancer in men with elevated PSA (2-10 ng/ml) and reduce unnecessary biopsies. The company also licenses biomarker manufacturing IP to third parties such as Immunovia for pancreatic cancer diagnostics.
Product overview
Proteomedix is a diagnostics company focused on prostate cancer diagnostics, operating as a Swiss subsidiary of Onconetix Inc. The company's primary offering is Proclarix, a CE-IVD certified blood-based biomarker test designed to improve prostate cancer diagnosis by identifying patients with elevated PSA levels who actually require further investigation. Proclarix is indicated for men with PSA levels between 2-10 ng/ml and enlarged prostate volume, and uses a proprietary algorithm combining thrombospondin 1 and cathepsin D measurements with PSA values to generate a risk score. The company also licensed manufacturing IP to Immunovia for their PancreaSure pancreatic cancer test.
Differentiator
Problem solved
Functional benefit
Products and services
- Proclarix CE-IVD certified blood-based diagnostic test for prostate cancer that combines two quantitative ELISA assays measuring thrombospondin 1 (THBS1) and cathepsin D (CTSD) biomarkers with a proprietary risk score algorithm to assess patient risk for clinically significant prostate cancer (Gleason Score ≥7). Indicated for men with elevated PSA levels between 2-10 ng/ml in the diagnostic grey zone to reduce unnecessary biopsies.
Quantifiable outcome
- 95% negative predictive value for detecting clinically significant prostate cancer (Gleason Score ≥7) at 90% sensitivity
- +5 more outcomes
Companies that use Proteomedix
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles3 records
Proteomedix technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability2 records
Feature4 records
Proteomedix partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered minor, core and strategic.
- Immunovia ABminorLicensing agreement where Proteomedix provides master cells for antibody production related to three of five biomarkers in Immunovia's PancreaSure pancreatic cancer test, plus license for key manufacturing IP. Immunovia to pay $700,000 in 2025-2026 plus 3% royalty on net sales from 2026-2032.
- Onconetix Inc. (formerly Blue Water Biotech)coreProteomedix acquired by Blue Water Biotech Inc. (NASDAQ: BWV) in share exchange transaction. Merged entity renamed Onconetix Inc. combines Proclarix diagnostic with Entadfi BPH treatment product. Proteomedix founders Ralph Schiess (as CSO) and Christian Brühlmann join Onconetix executive team.
- LabcorpcoreProteomedix granted Labcorp exclusive license to develop and commercialize Proclarix as a laboratory developed test (LDT) in the United States. Labcorp plans to conduct the PRIME study, a multi-center clinical validation study including up to 500 men across various ethnicities for U.S. market evaluation. Financial terms not disclosed.
- Biodiagnostica Montevergine Malzoni NetworkcoreFirst commercial laboratory in Italy to include Proclarix in routine testing. Part of Neuromed Group operating in laboratory diagnostics, microbiology, cytohistopathology, virology and genetics for over 30 years.
- New Horizon Health LimitedstrategicR&D partnership with Hong Kong-listed cancer screening company (stock code 6606.HK). New Horizon Health invested CHF 3.0 million in convertible loan to support joint program. Partnership builds on complimentary platform and biomarker developments for cancer patient management.
- University of Naples Federico IIstrategicUniversity of Naples Federico II implementing and evaluating Proclarix to make it routinely available in Italy. First clinical partner in Italy to locally implement and evaluate the test for prostate cancer patient management.
- Zhengzhou University Henan Cancer Hospital (ZUHCH)strategicCooperation to clinically validate Proclarix biomarker tests and bioinformatics for prostate cancer diagnostics in the Chinese population. Prospective study to assess biomarker-based triage of patients with elevated PSA suspicious for clinically significant prostate cancer.
- University Hospital Frankfurt MVZcoreFirst laboratory in Germany to offer Proclarix routinely. University Hospital Frankfurt MVZ provides comprehensive portfolio of histological, immunohistochemical and molecular analysis tools. Certified according to DIN EN ISO 9001:2008.
- Dynex TechnologiescoreStrategic partnership enabling Proteomedix to establish automated workflows for Proclarix and sell Dynex instruments to the global clinical market. Proclarix was clinically validated on Dynex DSX platform with protocols for DS2 and Agility platforms. Dynex has over 7,500 instrument systems globally.
- Center for Laboratory Medicine St. GallencoreFirst laboratory worldwide to offer Proclarix. ISO/IEC17025 accredited clinical laboratory delivering diagnostic services to Cantonal Hospital St. Gallen, public hospitals, and general practitioners/urologists in Eastern Switzerland. Over 200 staff, menu of more than 1500 tests.
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Proteomedix competitors and assessment
Company assessmentDirect peers
- OPKO Health: OPKO Health commercializes the 4Kscore test, a blood-based biomarker test for prostate cancer risk assessment. Directly comparable as both companies offer blood-based reflex tests to reduce unnecessary biopsies in men with elevated PSA.
- MdxHealth: MdxHealth offers SelectMDx and ConfirmMDx, urine and tissue-based molecular diagnostic tests for prostate cancer. Direct competitor in the prostate cancer diagnostic decision-support market with similar target customer segments (urologists and patients with elevated PSA).
- Myriad Genetics: Myriad Genetics offers Prolaris, a molecular diagnostic test for prostate cancer that assesses disease aggressiveness. Direct competitor in prostate cancer biomarker testing with established U.S. market presence and reimbursement.
Broad incumbents
- Beckman Coulter (Danaher): Beckman Coulter commercializes the Prostate Health Index (phi), a major competing prostate cancer biomarker test. Larger diagnostics incumbent with established laboratory channels and direct comparison data showed Proclarix outperforming phi in specificity.
- Exact Sciences: Exact Sciences (formerly Genomic Health) offers Oncotype DX Prostate and is a major player in cancer molecular diagnostics. Comparable as a broader cancer diagnostics platform with established laboratory infrastructure and reimbursement capabilities.
- QIAGEN: QIAGEN is a major molecular diagnostics company offering sample technologies and assays for prostate cancer testing including the PIA test. Comparable as a broader IVD/molecular diagnostics company with global laboratory partnerships.
- DiaSorin: DiaSorin is an IVD company specializing in immunoassays with a global presence in clinical diagnostics. Comparable as a larger IVD player offering automated immunoassay platforms to clinical laboratories.
- Bio-Techne: Bio-Techne (including Exosome Diagnostics) offers diagnostic and research tools in proteomics. Comparable as a broader proteomics-based diagnostics and life science tools company with biomarker discovery capabilities.
- Roche Diagnostics: Roche Diagnostics is the global leader in IVD with extensive immunoassay and clinical chemistry platforms. Comparable as the largest IVD incumbent with extensive laboratory partnerships, automated platforms, and broad biomarker testing menu.
Emerging players
- Olink Holding: Olink is a proteomics company providing high-multiplex immunoassay platforms for biomarker discovery. Comparable as a proteomics technology platform provider with overlapping biomarker discovery capabilities used in clinical research.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Proteomedix social profiles
Digital presenceProteomedix compliance and trust
Trust signalCompliance2 records
Proteomedix financial estimates
Financial estimateRevenue estimate
Valuation estimate
Proteomedix leadership team
Management profileNumber of profiles
Profiles12 records
Proteomedix funding detail
Funding detailFunding overview
Funding rounds9 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Proteomedix M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Proteomedix
What does Proteomedix do?
Proteomedix develops and commercializes Proclarix, a CE-IVD certified blood-based diagnostic test for prostate cancer. The test combines two quantitative ELISA assays measuring THBS1 and CTSD biomarkers with a proprietary risk score algorithm, designed to identify clinically significant prostate cancer in men with elevated PSA (2-10 ng/ml) and reduce unnecessary biopsies. The company also licenses biomarker manufacturing IP to third parties such as Immunovia for pancreatic cancer diagnostics.
Is Proteomedix a public or private company?
Proteomedix is a private company. It is classified as corporate owned and is currently operating.
When was Proteomedix founded?
Proteomedix was founded in 2010. It employs 1 to 10 people.
Where is Proteomedix based?
Proteomedix is headquartered in Schlieren, Switzerland, in the Europe region.
How does Proteomedix make money?
Three revenue lines are on record. Diagnostic Test Sales are the primary driver. The others are licensing Royalties (Immunovia) and labcorp U.S. License.
Who are Proteomedix's main competitors?
Direct peers on record are OPKO Health, MdxHealth and Myriad Genetics. Broad incumbents are Beckman Coulter (Danaher), Exact Sciences, QIAGEN, DiaSorin, Bio-Techne and Roche Diagnostics. Olink Holding is listed as an emerging player.
Does Proteomedix have an API?
No public API is recorded for Proteomedix.
What industry is Proteomedix in?
Proteomedix's product category is Prostate Cancer Diagnostics. Its primary akta.pro industry code is HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays), with a secondary code of HLAGANAB, Proteomics & Mass Spectrometry Services. Its NAICS code is 325413 and its SIC code is 2835.