What Diadem does

Diadem is a biotechnology company developing a blood-based diagnostic test for the early prediction and differential diagnosis of Alzheimer's disease (AD). The company's core technology exploits a proprietary antibody that targets a specific conformation of the p53 protein, enabling a non-invasive blood-based alternative to current diagnostic methods such as cerebrospinal fluid (CSF) analysis and amyloid PET imaging. The test is currently in the validation phase, leveraging data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study to demonstrate clinical efficacy in differentiating AD from other dementias.

The company serves healthcare providers, including neurology practices, memory clinics, hospitals, and healthcare systems, addressing the need for accessible, non-invasive early diagnostic tools. Diadem is pre-revenue; its commercial model is expected to rely on clinical laboratory testing services once the diagnostic is validated and cleared. The go-to-market approach is healthcare-focused, targeting medical providers for early AD diagnosis and intervention.

Founded in 2012 and headquartered in Brescia, Italy, with a US-registered entity (Diadem U.S., Inc.), the company has raised approximately $21.6 million across three 2022 funding events: a $10.99 million round co-led by CDP Venture Capital and Panakes Partners, an $8.15 million investment from the European Investment Bank, and a $2.5 million SBIR Phase II grant from the National Institute on Aging (NIH). Leadership includes CEO Michael Rasche and founders Prof. Memo Maurizio and Daniela Uberti. The company operates with a headcount of 1-10 employees.

Name

Diadem

Legal name

Diadem U.S., Inc.

Website

https://diademdx.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Diadem is a pre-revenue Italian biotechnology company developing a proprietary antibody-based blood test for the early detection and differential diagnosis of Alzheimer's disease, targeting healthcare providers including neurologists, memory clinics, and hospitals.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Proteomics & Biomarker Analytical Testing (HLAGADAG)

akta.pro secondary industries

Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN), Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

Keywords

• Blood-based diagnostics
• Alzheimer's biomarkers
• Neurodegenerative testing
• Clinical diagnostics
• Dementia prediction

Headquarters

HQ city

Brescia

HQ country

Italy

HQ region

Europe

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Blood-based Diagnostic Testing: The company is developing a blood test for Alzheimer's disease diagnosis. As the product is still in the validation phase with NIH funding, revenue generation has not yet commenced. Once validated and FDA cleared, the diagnostic test is expected to generate revenue through clinical laboratory testing services.

Go-to-market motion1 record

Core offering

Diadem is developing an innovative blood-based diagnostic test that exploits a proprietary antibody targeting a specific conformation of the p53 protein to enable early prediction of Alzheimer's disease and differentiation from other dementias. The test is designed as a non-invasive alternative to cerebrospinal fluid analysis and amyloid PET imaging, and is currently being validated using data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study.

Differentiator

Problem solved

Functional benefit

Products and services

• Blood Test for Alzheimer's Disease Prediction A blood-based biomarker test designed for early prediction of Alzheimer's disease and differentiation from other dementias, currently in validation stages using data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study. The test exploits a proprietary antibody targeting a specific conformation of the p53 protein and is intended as a non-invasive alternative to cerebrospinal fluid analysis and amyloid PET imaging for use by healthcare providers diagnosing dementia.

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• ADNI (Alzheimer's Disease Neuroimaging Initiative)coreStrategic or Co-development PartnerDiadem's blood test validation leverages data from the ADNI study, a major longitudinal research initiative designed to validate biomarkers for Alzheimer's disease detection and progression monitoring.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Emerging players

• Quanterix: Quanterix provides ultra-sensitive Simoa biomarker detection technology used by researchers developing blood-based neurodegenerative diagnostics, making it both a potential enabler and competitor to Diadem's assay platform.
• SomaLogic: SomaLogic operates a large-scale proteomics platform (SomaScan) that has been used in Alzheimer's biomarker discovery studies — an emerging peer with overlapping protein-biomarker diagnostic ambitions.
• ADx NeuroSciences: ADx NeuroSciences specializes in biomarker assays for neurodegenerative diseases, including Alzheimer's, and is a focused emerging peer in the same diagnostic biomarker category.

Direct peers

• ALZpath: ALZpath developed a proprietary pTau217 blood biomarker assay for Alzheimer's detection and has secured commercialization partnerships with major diagnostics players — a direct functional peer in blood-based AD diagnostics.
• Fujirebio: Fujirebio (H.U. Group) offers both CSF and blood-based Alzheimer's biomarker assays (e.g., Lumipulse pTau217/β-Amyloid 1-42) and is a leading established diagnostics peer in the same neurodegenerative biomarker category.
• C2N Diagnostics: C2N Diagnostics developed PrecivityAD, the first commercially available blood test for Alzheimer's disease, making it the most direct competitor to Diadem's blood-based AD diagnostic approach.
• Araclon Biotech (Grifols): Araclon Biotech, owned by Grifols, develops the ABtest amyloid blood-based assay for early Alzheimer's detection — a direct functional peer in blood-based AD diagnostics.

Broad incumbents

• Bio-Techne: Bio-Techne supplies proteomic reagents and biomarker assay kits (including for neurodegeneration research) used by academic and commercial labs developing diagnostics, making it an adjacent incumbent in the biomarker tools supply chain.
• Roche Diagnostics: Roche offers the Elecsys Alzheimer's CSF assays and has launched pTau217 blood-based testing, leveraging its global IVD installed base — a broad incumbent that competes across the same Alzheimer's diagnostic workflow.
• Sysmex: Sysmex is a global IVD/hematology incumbent expanding into neurodegenerative biomarkers through partnerships and assay development — a broad incumbent operating in the same clinical diagnostics infrastructure that would distribute Alzheimer's blood tests.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds3 records

Investors4 records

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 Diadem