What MLA Diagnostics does

MLA Diagnostics is a Dutch molecular diagnostics company founded in 2019 and headquartered at the Brightlands Maastricht Health Campus in Maastricht, Netherlands. The company is developing a prognostic test for early-stage (Stage I and Stage II) cutaneous melanoma, targeting the clinical gap that roughly 20–30% of early-stage melanoma patients classified as low-risk by classical indicators (tumor thickness, ulceration) subsequently develop recurrence or metastasis. The test detects methylation of the LY75 (lymphocyte antigen 75) gene promoter using methylation-specific PCR (msPCR) and integrates that epigenetic signal with patient clinical and pathological parameters into a multi-parameter risk assessment tool. The assay is designed to drop into existing PCR/qPCR-based workflows in clinical pathology laboratories, so it does not require new instrumentation at customer sites.

The company is pre-revenue and is pursuing CE mark certification and clinical trials as the gating milestones for commercialization. Its intended go-to-market is B2B enterprise field sales to clinical pathology labs and treating clinicians (dermatologists, pathologists, oncologists), with revenue expected to come from one-time licensing or sale of the molecular test/service once regulatory clearance is obtained. There is no publicly disclosed pricing. Ownership is private and venture-backed; MLA Diagnostics was co-founded by venture builder NLC Health Ventures, Brightlands Life Science Ventures, Maastricht University academic Prof. Dr. Manon van Engeland, and CEO Egbert Smit, PhD, alongside an in-house R&D, quality/regulatory, and fractional finance team of roughly 1–10 people.

MLA Diagnostics has assembled a layered financing stack combining non-dilutive Dutch and European grants (MIT Haalbaarheid, EIT Headstart, LIOF LBDF POP, Rabobank Innovation Loan, RVO VFF, KWF Kankerbestrijding) with equity from NLC Health Ventures (via the €2.2M Momentum fund in 2020 and a follow-on in 2023) and Brightlands Life Science Ventures, alongside co-investment from LIOF. A strategic seven-figure round closed in November 2023 explicitly to advance clinical trials. Scientific and commercial partnerships with Maastricht University (biomarker discovery), Pathologie DNA (methylation assay development), KEMTA and HI-NL (health technology assessment and reimbursement strategy), and MSD/UtrechtInc (early commercial coaching) further scaffold the technical and market-access development path.

Name

MLA Diagnostics

Legal name

MLA Diagnostics

Website

https://mladx.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

MLA Diagnostics is a Dutch molecular diagnostics startup developing a DNA methylation-based prognostic test for early-stage melanoma, targeting clinical pathology labs and treating clinicians with an LY75 biomarker assay designed to integrate into existing laboratory workflows.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Melanoma prognostic tests
• DNA methylation diagnostics
• Cancer biomarker assays
• Epigenetic molecular diagnostics
• Melanoma risk assessment

Headquarters

HQ city

Maastricht

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Molecular Diagnostic Test Sales: Pre-revenue company developing a DNA methylation-based diagnostic test for melanoma prognosis. Revenue model will likely involve selling diagnostic test kits/services to clinical pathology labs and healthcare institutions once CE mark is obtained and clinical trials are completed.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

MLA Diagnostics develops a DNA methylation-based molecular diagnostic test that detects methylation of the LY75 gene promoter to discriminate between low- and high-risk melanoma disease, predicting recurrence risk within 5 years. The test integrates into standard clinical pathology laboratory workflows and is enriched with patient clinical and pathological parameters to support clinicians in tailoring treatment intensity for early-stage melanoma patients.

Product overview

MLA Diagnostics offers a unified core product: a multi-parameter melanoma risk assessment tool that combines a DNA methylation-based molecular test (the LY75 Methylation Test) with clinical and pathological parameters. The LY75 Methylation Test serves as the epigenetic foundation of the tool, detecting methylation of the lymphocyte antigen 75 (LY75) gene promoter to predict poor clinical outcomes, while the integrated multi-parameter framework enriches this with patient clinical data for improved prognostic assessment of melanoma patients.

Differentiator

Problem solved

Functional benefit

Products and services

• Melanoma Risk Assessment Tool A multi-parameter non-invasive melanoma risk assessment tool that identifies individuals at high risk of metastasis or recurrence. Using epigenetic tumor information (DNA methylation of the LY75 gene promoter) enriched with patient clinical and pathological parameters, it provides a more accurate prognosis to guide clinicians in tailoring treatment intensity and ensuring precise, personalized patient care. Targeted at clinical pathology labs and healthcare providers (dermatologists, pathologists, oncologists) for early-stage (Stage I/II) melanoma patients.

Quantifiable outcome

• Identifies high-risk patients among early-stage melanoma patients who may not present with high-risk classical indicators

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Maastricht UniversitycoreStrategic or Co-development Partner · 31 January 2022Teaming up with Maastricht University in a TKI academic project for discovery of clinically relevant methylation markers. Prof. Manon van Engeland is Professor of Pathobiology of Cancer at Maastricht University Medical Center.
• Pathologie DNAcoreStrategic or Co-development Partner · 23 December 2020Top-level diagnostics specialists collaborating with MLA Diagnostics in a MIT R&D samenwerkings research project to improve melanoma diagnostics and prognostics using methylation-based assays.
• KEMTA (Clinical Epidemiology & Medical Technology Assessment)minorStrategic or Co-development Partner · 30 October 2019Collaboration partner in LBDF POP Health Technology Assessment project consisting of patient journey inventory, health economic modelling, and expert round table sessions.
• HI-NL (Health Innovation Netherlands)minorStrategic or Co-development Partner · 30 October 2019Health innovation network partner in LBDF POP Health Technology Assessment project supporting health economic modelling and reimbursement strategy.
• MSD LAB1891 / UtrechtIncminorGTM or Marketing Partner · 16 August 2019MSD LAB1891 and UtrechtInc partnered to support 3 early stage startups selected by MSD. MLA Diagnostics gained valuable clinical insights into pharma drivers and interests in biomarker applications, companion diagnostics, predictive biomarkers, and personalized medicine through coaching, workshops, and access to global network.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NeraCare: NeraCare is a German-European molecular diagnostics company developing the DecisionDx-Melanoma-related prognostic assays (MelaGenix) for early-stage melanoma, serving the same European dermatology/pathology customer base with a similar prognostic positioning to MLA Diagnostics.
• Epigenomics AG: Epigenomics AG is a German molecular diagnostics company specializing in DNA methylation-based cancer detection (Epi proColon for colorectal cancer), directly comparable to MLA on platform technology (DNA methylation biomarkers), workflow integration into clinical labs, and oncology focus.
• SkylineDx: SkylineDx is a Dutch molecular diagnostics company developing prognostic gene-expression tests for melanoma (e.g., DecisionDx-Melanoma via CP-GEP), directly competing with MLA Diagnostics in early-stage melanoma recurrence risk assessment for dermatology and pathology labs in Europe.
• Castle Biosciences: Castle Biosciences is a US-based molecular diagnostics company whose lead product DecisionDx-Melanoma is a gene-expression test predicting metastasis risk in early-stage melanoma patients, making it the most established direct competitor to MLA's LY75 methylation prognostic test.
• DermTech: DermTech is a US-based molecular diagnostics company offering non-invasive genomic skin tests, including melanoma detection from adhesive skin samples - adjacent to MLA's melanoma prognostic space with overlap in dermatology lab adoption channels and epigenetic/molecular skin cancer diagnostics.

Emerging players

• VolitionRx: VolitionRx is a US-based epigenetics diagnostics company developing Nu.Q blood-based cancer detection tests using nucleosome methylation biomarkers - comparable to MLA as an emerging methylation-based diagnostics developer operating in oncology, though broader than the melanoma niche.
• MdxHealth: MdxHealth is a Belgium/US molecular diagnostics company offering methylation-based urology and oncology tests (SelectMDx, ConfirmMDx), comparable to MLA as an emerging European molecular diagnostics player using epigenetic biomarkers targeting specialized oncology indications.

Broad incumbents

• Exact Sciences: Exact Sciences (COLOGUARD) commercializes Prof. van Engeland's NDRG4 methylation biomarker for colorectal cancer screening and has built a global footprint in methylation-based IVD - relevant to MLA via shared scientific lineage of its co-founder and as a benchmark for methylation-biomarker commercial scale.
• NeoGenomics: NeoGenomics is a US-based oncology-focused clinical lab and molecular diagnostics services provider with broad cancer genetic and methylation test offerings - comparable as an incumbent cancer diagnostics player whose footprint and payer contracts could compete with MLA's pathology-lab channel.
• Myriad Genetics: Myriad Genetics is an established molecular diagnostics company with oncology genetic tests (including melanoma risk/gene panels) and broad lab infrastructure - representative of larger incumbents that could enter or displace targeted melanoma prognostic tests like MLA's.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds2 records

Investors3 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 MLA Diagnostics