Pre Diagnostics
Pre Diagnostics AS is a Norwegian diagnostics company developing CE-marked blood-based biomarker tests for early detection of Alzheimer's disease and pipeline products for Parkinson's disease and ARIA monitoring, serving pharmaceutical companies, research institutions, and hospitals via its proprietary intracellular Aβ clearance platform and Pre Neurolab service laboratory.
- Company typePrivate
- Founded2013
- HeadquartersOslo, Norway
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Pre Diagnostics does
Pre Diagnostics AS is a privately held Norwegian diagnostic company founded in 2013 in Oslo, developing biomarker-based blood tests for early detection and management of neurodegenerative diseases, primarily Alzheimer's and Parkinson's. The company's core technology is a proprietary two-step platform that measures beta-amyloid (Aβ) clearance efficiency inside blood monocytes using positive isolation with paramagnetic beads followed by proprietary monoclonal antibody detection of specific Aβ cut-point fragments (aa-34, 20-aa, aa-40/42). Its lead commercial product, PreADx, is the first CE-marked in-vitro diagnostic blood test using intracellular peptide quantitation for early Alzheimer's disease detection, and it has also CE-marked the Plasma Aβx-34 biomarker for monitoring Amyloid-Related Imaging Abnormalities (ARIA) during anti-amyloid immunotherapy, with BloodCellDx-AD in development for ARIA risk prediction.
Pre Diagnostics operates three revenue streams: (i) professional biomarker services through its wholly owned subsidiary Pre Neurolab, a service laboratory established in 2022 and expanded in February 2026 with MSD and Kleeya immunoassay platforms supporting studies from 50 to several thousand samples; (ii) licensing and royalty arrangements under active dialogue with pharmaceutical companies for clinical research, patient monitoring, and diagnostic applications; and (iii) one-time license sales of CE-marked diagnostic tests. The company sells primarily to pharmaceutical companies conducting neurodegenerative clinical trials and to academic research institutions and hospitals, with secondary outreach to clinicians via the PreADx test. The commercial footprint is currently European, anchored by participation in the €7.7 million Horizon Europe-funded FluiDx-AD consortium led by Oslo University Hospital, alongside the Norwegian Research Council-funded Parkinson's program. The company is small (1-10 employees), ISO 13485 certified, and has historically been financed primarily through EU and Norwegian research grants rather than commercial revenue.
Pre Diagnostics firmographics
Firmographics- Name
- Pre Diagnostics
- Legal name
- Pre Diagnostics AS
- Website
- https://pre-diagnostics.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Pre Diagnostics AS is a Norwegian diagnostics company developing CE-marked blood-based biomarker tests for early detection of Alzheimer's disease and pipeline products for Parkinson's disease and ARIA monitoring, serving pharmaceutical companies, research institutions, and hospitals via its proprietary intracellular Aβ clearance platform and Pre Neurolab service laboratory.
- Ownership category
- akta.pro rank
Pre Diagnostics industry classification
Industry- Product category
- Neurodegenerative Disease Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)
- akta.pro secondary industries
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Proteomics & Biomarker Analytical Testing (HLAGADAG)
Keywords
Where Pre Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Oslo
- HQ country
- Norway
- HQ region
- Europe
Offices2 records
Markets served
Pre Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Biomarker Services (Pre Neurolab): Pre Neurolab provides analytical biomarker services for neurodegenerative diseases, supporting research biomarker studies using advanced immunoassay platforms. Services accommodate sample sizes ranging from 50 to several thousands. Supports standard biomarker panels and custom assay development.
- Pharma Clinical Research Partnerships: The company is in active dialogue with pharmaceutical companies to commercialize biomarkers for clinical research, patient monitoring/screening, and diagnostics for neurodegenerative diseases.
- Diagnostic Test Sales: PreADx blood test (CE-marked) for early detection of Alzheimer's disease through measurement of Aβ clearance efficiency. Additional diagnostic products in development for Alzheimer's and Parkinson's disease.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
Pre Diagnostics product offering
Product offeringCore offering
Pre Diagnostics develops and commercializes proprietary blood-based biomarker diagnostics for neurodegenerative diseases. Its core offering is the PreADx CE-marked in-vitro diagnostic blood test, which uses an intracellular monocyte-based two-step platform with proprietary monoclonal antibodies to detect early Alzheimer's disease by measuring ongoing Aβ clearance. The company also operates Pre Neurolab, a service laboratory providing analytical biomarker services using advanced immunoassay platforms (MSD and Kleeya) supporting neurodegenerative disease research studies of 50 to several thousand samples.
Product overview
Pre Diagnostics offers a portfolio of biomarker-based diagnostic products for neurodegenerative diseases centered on its proprietary Two-Step Platform Technology. The core platform enables measurement of Aβ clearance efficiency through monocyte isolation and proprietary antibody detection. Key products include PreADx (CE-marked Alzheimer's diagnostic), Plasma Aβx-34 CE-Marked Biomarker (ARIA monitoring), BloodCellDx-AD (ARIA risk prediction, in development), and a Parkinson's disease blood test (in development). The company also operates Pre Neurolab, a dedicated service laboratory offering analytical biomarker services using advanced immunoassay platforms including MSD and Kleeya, supporting studies from 50 to several thousand samples. The FluiDx-AD consortium project is developing additional saliva and blood-based diagnostic tests.
Differentiator
Problem solved
Functional benefit
Brands
- Pre Neurolab: Service laboratory providing analytical biomarker services for neurodegenerative diseases using advanced immunoassay platforms. Supports studies from 50 to several thousand samples.
- PreADx
- BloodCellDx-AD
- Plasma Aβx-34
Products and services
- PreADx First CE-marked in-vitro diagnostic blood test using intracellular peptide quantitation for accurate Alzheimer's disease diagnosis. Measures ongoing clearance of beta amyloid (Abeta) via a two-step process involving monocyte isolation and proprietary monoclonal antibody detection.
- Pre Neurolab Specialized service laboratory providing analytical biomarker services for neurodegenerative diseases using advanced immunoassay platforms (MSD digital immunoassay and Kleeya). Supports studies ranging from 50 to several thousand samples with ISO 13485-compliant SOP-based analytical methods.
- Plasma Aβx-34 CE-Marked Biomarker CE-marked plasma biomarker assay used to monitor Amyloid-Related Imaging Abnormalities (ARIA) during the course of Alzheimer's disease immunotherapy treatment.
Quantifiable outcome
- Reduces Alzheimer's disease diagnosis time from years to months through early detection
- +2 more outcomes
Companies that use Pre Diagnostics
Customer profileSegments3 records
Ideal customer profiles3 records
Pre Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Pre Diagnostics partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- Oslo University HospitalcoreLeading the FluiDx-AD consortium. Pre Diagnostics AS is a key partner in this Horizon Europe-funded initiative bringing together experts across Europe to advance precision diagnostics for Alzheimer's disease. The consortium includes leading hospitals, patient organisations, and SMEs.
- FluiDx-AD Consortium PartnerscoreHorizon Europe-funded initiative including leading hospitals, patient organisations, and SMEs across Europe. Consortium aims to improve early diagnosis and management of Alzheimer's disease through development of three complementary diagnostic tests based on saliva, plasma, and whole blood.
- Norway Health TechminorHelped find and adapt the FluiDx-AD project to the RIA programme within Horizon Europe.
- InnovaytminorHelped find and adapt the FluiDx-AD project to the RIA programme within Horizon Europe.
- Innovation NorwayminorContributed to creating a broader EU funding strategy for the FluiDx-AD project.
Scale indicators5 records
Recent moves7 records
Expansion highlights6 records
Pre Diagnostics competitors and assessment
Company assessmentDirect peers
- ALZpath: ALZpath develops the ALZpathDx pTau217 blood test for Alzheimer's detection and is a direct peer in the blood-based AD biomarker space. Both companies target the same clinical and pharma trial customer base with non-invasive AD diagnostics, though ALZpath uses a plasma pTau mechanism versus Pre Diagnostics' intracellular approach.
- Fujirebio: Fujirebio is a specialty IVD company focused on neurodegenerative disease diagnostics, including CSF and blood-based assays for Alzheimer's (Lumipulse). It is a direct peer competing for the same clinical laboratory customers and pharma clinical trial biomarker contracts in the AD diagnostic category.
- ADx NeuroSciences: ADx NeuroSciences is a Belgian biotech developing proprietary antibodies and biomarker assays for neurodegenerative diseases including Alzheimer's. It is a direct peer in the AD biomarker development space and a potential collaborator or competitor for pharma pharma pharma trial biomarker supply.
- C2N Diagnostics: C2N Diagnostics is the most direct comparable peer, offering the PrecivityAD blood test for Alzheimer's disease detection using mass spectrometry-based Aβ42/40 ratio measurement. Both companies compete for pharma clinical trial biomarker budgets and clinical AD diagnostic adoption in the same blood-based AD biomarker category.
Broad incumbents
- Quanterix: Quanterix provides the Simoa ultra-sensitive single-molecule array immunoassay platform used widely in neurodegenerative disease biomarker research, including by pharma for AD clinical trials. It is a broad incumbent whose technology underpins competing blood-based AD assays, and overlaps with Pre Diagnostics' immunoassay-based biomarker service offerings.
- Roche Diagnostics: Roche Diagnostics offers the Elecsys Amyloid plasma panel (pTau181, Aβ42/40) for AD diagnostics and is the largest commercial IVD competitor in the blood-based AD space. As a broad incumbent with global commercial reach and FDA-cleared assays, Roche represents both a competitive threat and potential partnership channel for Pre Diagnostics.
- Bio-Techne: Bio-Techne provides proteomic biomarker tools, antibodies, and assay kits used in neurodegenerative disease research, including the ProteinSimple platform. It is a broad incumbent in life science tools whose products and services overlap with Pre Neurolab's immunoassay service offerings and whose research reagents compete with Pre Diagnostics' proprietary antibodies.
- Euroimmun (PerkinElmer): Euroimmun, now part of Revvity/PerkinElmer, is a major specialty diagnostics company offering a broad portfolio of immunoassays for neurodegenerative and autoimmune diseases. As a broad incumbent with established pharma and clinical lab relationships, it overlaps with Pre Diagnostics' immunoassay-based biomarker service business.
- Sysmex: Sysmex is a major in-vitro diagnostics company with expanding presence in neurodegenerative disease biomarkers, including partnerships for blood-based AD assays in Japan and Europe. It is a broad incumbent whose established global clinical lab distribution network represents both competition and a potential commercialization channel for Pre Diagnostics.
Emerging players
- Biogen: Biogen is a major Alzheimer's therapeutics company (lecanemab co-developer with Eisai) that is increasingly developing in-house and partnered companion diagnostics for AD, including blood-based screening tools. It is an emerging player in the AD biomarker space with strong pharma trial pull-through demand that aligns with Pre Diagnostics' pharma partnership target customer.
Market position
Strengths1 record
Weaknesses1 record
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Pre Diagnostics social profiles
Digital presencePre Diagnostics compliance and trust
Trust signalCompliance1 record
Pre Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pre Diagnostics leadership team
Management profileNumber of profiles
Profiles4 records
Pre Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries1 record
Pre Diagnostics funding detail
Funding detailFunding overview
Funding rounds2 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pre Diagnostics 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 Pre Diagnostics
What does Pre Diagnostics do?
Pre Diagnostics develops and commercializes proprietary blood-based biomarker diagnostics for neurodegenerative diseases. Its core offering is the PreADx CE-marked in-vitro diagnostic blood test, which uses an intracellular monocyte-based two-step platform with proprietary monoclonal antibodies to detect early Alzheimer's disease by measuring ongoing Aβ clearance. The company also operates Pre Neurolab, a service laboratory providing analytical biomarker services using advanced immunoassay platforms (MSD and Kleeya) supporting neurodegenerative disease research studies of 50 to several thousand samples.
Is Pre Diagnostics a public or private company?
Pre Diagnostics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Pre Diagnostics founded?
Pre Diagnostics was founded in 2013. It employs 1 to 10 people.
Where is Pre Diagnostics based?
Pre Diagnostics is headquartered in Oslo, Norway, in the Europe region.
How does Pre Diagnostics make money?
Three revenue lines are on record. Biomarker Services (Pre Neurolab) is the primary driver. The others are pharma Clinical Research Partnerships and diagnostic Test Sales.
Who are Pre Diagnostics's main competitors?
Direct peers on record are ALZpath, Fujirebio, ADx NeuroSciences and C2N Diagnostics. Broad incumbents are Quanterix, Roche Diagnostics, Bio-Techne, Euroimmun (PerkinElmer) and Sysmex. Biogen is listed as an emerging player.
Does Pre Diagnostics have an API?
No public API is recorded for Pre Diagnostics.
What industry is Pre Diagnostics in?
Pre Diagnostics's product category is Neurodegenerative Disease Diagnostics. Its primary akta.pro industry code is HLAGAEAB, Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry), with a secondary code of HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays). Its NAICS code is 325413 and its SIC code is 2835.