What Devyser does

Devyser Diagnostics AB (publ) is a Stockholm-based molecular diagnostics company founded in 2004 that develops, manufactures, and commercializes DNA diagnostic test kits for clinical laboratories across more than 65 countries. Its portfolio spans next-generation sequencing (NGS) assays and multiplex PCR-based kits organized around five diagnostic areas: post-transplantation monitoring (donor-derived cell-free DNA, chimerism, HLA loss), reproductive health (prenatal aneuploidy, fetal RHD screening, male infertility), hereditary disease testing (cystic fibrosis CFTR, thalassemia), hereditary oncology (BRCA, HBOC, Lynch syndrome), and cardiovascular genetics (thrombophilia, familial hypercholesterolemia). The company's core technical differentiator is a patented single-tube technology that compresses complex multi-step workflows into a single reaction, reducing hands-on time from 1-2 days to approximately 45 minutes and delivering results in 1-2 days versus traditional 4-14 day turnarounds, with chimerism detection sensitivity down to 0.05%.

Devyser generates revenue through three primary streams: direct kit sales via in-house sales offices in Europe and the US (8 offices), exclusive global distribution of transplant products through Thermo Fisher Scientific, and clinical laboratory services from its CLIA-certified Devyser Genomic Laboratories in Roswell, Georgia. A January 2026 strategic supply agreement with Illumina positions Devyser as a systems integrator enabling reagent rental models for sequencing instruments in Europe, creating a recurring revenue stream alongside consumable kit sales. The company complements its kit business with proprietary software products (Advyser Solid Organs, Advyser Chimerism, Amplicon Suite) and follows a tender-and-quote pricing model, with notable contract wins including a five-year SEK 8.9 million regional tender in Italy and a SEK 25 million two-year service agreement with Cyted.

In FY2025, Devyser achieved revenue of SEK 250.5 million with its first positive full-year operating result of SEK 10.1 million, reversing a SEK 62 million loss in 2024, and maintained four consecutive quarters of profitability into Q1 2026 with an 81.6% gross margin. The company is listed on Nasdaq First North Premier Growth Market Stockholm under ticker DVYSR following a December 2021 IPO that raised approximately SEK 300 million. Recent strategic activity includes the April 2026 acquisition of CyberGene AB for SEK 12.2 million, multiple IVDR Class C certifications including the first IVDR-compliant NGS thalassemia assay, and leadership transitions with Jan Wahlström appointed CEO in August 2025.

Name

Devyser

Legal name

Devyser Diagnostics AB (publ)

Website

https://devyser.com

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

101–250 employees

Short description

Devyser Diagnostics AB is a Stockholm-based molecular diagnostics company that develops and sells NGS and PCR-based DNA test kits to clinical laboratories in 65+ countries, with primary focus on post-transplantation monitoring, reproductive health, hereditary disease, and oncology testing. The company also operates a CLIA-certified laboratory in the US and is listed on Nasdaq First North Stockholm under ticker DVYSR.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

akta.pro secondary industries

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ)

Keywords

• Genetic diagnostic kits
• NGS clinical assays
• Molecular diagnostics
• Transplant monitoring tests
• Prenatal genetic testing

Headquarters

HQ city

Hägersten

HQ country

Sweden

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic kit sales: Devyser develops, manufactures, and sells DNA diagnostic test kits to clinical laboratories. Products include NGS assays, fragment analysis kits, and related reagents. Revenue is generated through direct sales and distributor relationships across 65+ countries.
2. Sequencing instruments and products: Through strategic agreement with Illumina, Devyser provides sequencing instruments and related products to customers, enabling reagent rental models rather than traditional capital purchases.
3. Laboratory services: Devyser Genomic Laboratories, a CLIA-certified laboratory in Atlanta, offers clinical testing services to hospitals, laboratories, and pharmaceutical partners. Revenue from service agreements with partners like Cyted (estimated SEK 25 million over 2 years).

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels6 records

Core offering

Devyser develops, manufactures, and sells DNA diagnostic test kits based on next-generation sequencing (NGS) and multiplex PCR technologies for clinical laboratories worldwide. Its portfolio covers post-transplantation monitoring (dd-cfDNA, chimerism, HLA loss), hereditary cancer screening (BRCA, Lynch syndrome), prenatal diagnostics (aneuploidy, fetal RHD), cystic fibrosis, thalassemia, cardiovascular diseases, and male infertility. The company also operates a CLIA-certified laboratory in Atlanta offering clinical testing services and proprietary analysis software (Advyser, Amplicon Suite).

Product overview

Devyser is a pioneering provider of diagnostic DNA test kits and genetic testing solutions for clinical laboratories. The company offers a comprehensive portfolio of NGS-based and PCR-based diagnostic products organized across multiple diagnostic areas: post-transplantation monitoring (chimerism, cfDNA, HLA loss), oncology (hereditary cancer panels for BRCA, Lynch syndrome), reproductive health (prenatal aneuploidy detection, fetal RHD screening, male infertility), cystic fibrosis (CFTR testing), and cardiovascular diseases (thrombophilia, familial hypercholesterolemia). Devyser's products include rapid aneuploidy tests (Devyser Compact, Complete, Extend, Resolution series), comprehensive NGS assays (Thalassemia, CFTR, BRCA, HBOC, LynchFAP), and transplantation monitoring solutions (Accept cfDNA, Chimerism NGS, HLA Loss). The portfolio is complemented by software products (Advyser Solid organs, Advyser Chimerism, Amplicon Suite) for data analysis and interpretation. Following the 2026 acquisition of CyberGene, the portfolio expanded to include Cybergene ChromoQuant products for prenatal, pregnancy loss, and male infertility diagnostics. Devyser also operates Devyser Genomic Laboratories, a CLIA-certified service laboratory in Atlanta, and provides laboratory services to pharmaceutical companies. Products are distributed in 65+ countries through direct sales offices in Europe and the US, as well as distribution partnerships including Thermo Fisher Scientific for transplantation products globally and Illumina for MiSeqDx platform integration.

Differentiator

Problem solved

Functional benefit

Brands

• Cybergene ChromoQuant®: Product brand under CyberGene for prenatal, pregnancy loss, and male infertility diagnostics.
• Advyser Solid organs
• Advyser Chimerism
• Amplicon Suite
• Devyser Genomic Laboratories

Products and services

• One Lambda Devyser Accept cfDNA Single-tube NGS assay for detection of donor-derived cell-free DNA (dd-cfDNA) in blood samples from kidney transplant patients with high sensitivity for monitoring organ damage and rejection.
• One Lambda Devyser Chimerism NGS NGS assay for measuring chimerism accurately down to 0.05% minority fraction for screening and follow-up of stem cell transplanted patients.
• Devyser HLA Loss High-precision NGS assay for detecting HLA loss in mismatched transplant settings, designed exclusively for post-transplantation research use.
• Devyser Compact Rapid genetic test for prenatal chromosome testing using single-tube PCR for detecting fetal chromosomal abnormalities including Down syndrome and Turner syndrome.
• Devyser Complete
• Devyser RHD
• Devyser Thalassemia NGS
• Devyser Thalassemia v2 First IVDR-compliant NGS assay for genetic analysis of thalassemia and sickle cell disease in a single consolidated workflow, with Class C certification under EU IVDR.
• Devyser CFTR NGS Complete sequencing of CFTR gene to detect all mutations including the 100 variants from ACMG recommendations in a single assay for cystic fibrosis diagnosis.
• Devyser BRCA NGS NGS assay for detecting all mutations in BRCA1 and BRCA2 genes for hereditary breast cancer risk assessment.
• Devyser HBOC NGS NGS assay for hereditary breast and ovarian cancer gene panel testing.
• Devyser BRCA PALB2 NGS NGS assay for detection of sequence variants in BRCA1, BRCA2 and PALB2 genes associated with hereditary cancer risk.
• Devyser LynchFAP NGS solution for confident localization of variants in all exons of PMS2 gene for Lynch syndrome and FAP diagnostics.
• Devyser AZF Extension Y-chromosomal microdeletion test for male infertility diagnostics, updated to latest 2023 EQA guidelines.
• Devyser AZF v2 Updated Y-chromosomal microdeletion test for male infertility diagnostics.
• Devyser Thrombophilia Genetic test for thrombophilia risk assessment in cardiovascular diseases.
• Devyser FH NGS NGS assay for familial hypercholesterolemia diagnosis and cascade screening.
• Devyser CVD Cardiovascular disease genetic testing solution for monogenic and polygenic familial conditions.
• Devyser Genomic Blood Typing Genomic blood typing solution for transfusion medicine applications.
• Devyser CFTR Core Fragment analysis test for CFTR gene mutations used for screening and confirmation of cystic fibrosis.
• Cybergene ChromoQuant Product line from acquired CyberGene AB covering prenatal diagnostics, pregnancy loss diagnostics, and male infertility diagnostics using ChromoQuant technology.
• Advyser Solid Organs IVDR-certified software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation, intended for use with One Lambda Devyser Accept cfDNA.
• Advyser Chimerism Software for chimerism analysis data interpretation for stem cell transplantation monitoring.
• Amplicon Suite Software for genetic data analysis, acquired through SmartSeq S.r.l. acquisition, enabling Devyser to supply the software independently.
• Devyser Genomic Laboratories CLIA-certified and CAP-accredited laboratory in Atlanta, Georgia offering clinical test services for hereditary diseases, oncology, and post-transplant monitoring, and providing laboratory services to pharmaceutical companies for research support.

Quantifiable outcome

• Hands-on time reduced from 1-2 days to ~45 minutes
• +5 more outcomes

Named customers6 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature6 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• IlluminacoreTechnology or Integration · 28 January 2026Strategic supply agreement where Devyser provides Illumina sequencing instruments and related products to customers. Devyser acts as systems integrator for European reagent rental market. Also includes IVD development agreement for regulatory registrations of Devyser's NGS tests on MiSeqDx platform.
• Thermo Fisher ScientificcoreStrategic or Co-development Partner · 29 October 2024Collaboration with Thermo Fisher Scientific to obtain FDA approval for One Lambda Devyser Accept cfDNA, a cobranded NGS solution for detecting donor-derived cell-free DNA in kidney transplant patients. Thermo Fisher is exclusive global distributor of Devyser's transplantation products.
• University of ZurichminorStrategic or Co-development Partner · 29 February 2024Collaborative study with Departments of Immunology and Nephrology at University of Zurich, including Dr. Jakob Nilsson, using One Lambda Devyser Accept cfDNA assay. Published article demonstrating dd-cfDNA detection in dual donor kidney transplant patients.
• CytedminorStrategic or Co-development Partner · 17 January 2024First commercial agreement for Devyser Genomic Laboratories. Cyted will use Devyser's CLIA-certified laboratory services for their Heartburn Health Check using EndoSign test in US markets. Initial period of 2 years with estimated revenue of SEK 25 million.
• IlluminacoreTechnology or Integration · 8 January 2024IVD development agreement enabling Devyser to develop and offer its in vitro diagnostic tests on Illumina MiSeqDx NGS instrument in US and Europe. Allows regulatory registrations of Devyser's tests on FDA-regulated and CE-IVD-marked sequencing platform.
• Thermo Fisher ScientificminorStrategic or Co-development Partner · 13 September 2023Collaboration agreement to promote laboratory services. Goal is to partner with pharmaceutical companies to support their development projects using Devyser's assays at the CLIA-certified laboratory.
• Thermo Fisher ScientificcoreChannel Partner/ Reseller/ Distributor · 24 April 2023Exclusive collaboration and distribution agreement where Thermo Fisher markets and sells Devyser's post-transplant monitoring products (One Lambda Devyser Accept cfDNA and One Lambda Devyser Chimerism) under combined brands. Originally covered North America and Europe, expanded in September 2023 to include Brazil. This is a major channel partnership for Devyser's transplant diagnostics portfolio.

Scale indicators14 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• CareDx: CareDx is the US leader in transplant diagnostics with AlloSure dd-cfDNA and AlloMap. It is the closest direct competitor to Devyser's One Lambda Devyser Accept cfDNA and chimerism assays, targeting the same transplant nephrology and hematology customers with NGS-based surveillance.
• Eurofins Genomics: Eurofins Genomics operates genetic testing services and kit manufacturing across Europe, including prenatal, hereditary disease, and transplant-adjacent assays. It is a comparable European diagnostics platform with both kit and laboratory services offerings overlapping Devyser.
• Centogene: Centogene provides rare disease genetic diagnostics, including thalassemia, cystic fibrosis, and prenatal screening. It overlaps with Devyser on CFTR, thalassemia, and hereditary disease kit portfolios, particularly in EMEA markets.
• Invitae: Invitae is a genetic testing services and kit provider covering hereditary cancer, reproductive health, and rare disease panels. Although currently undergoing restructuring, its menu directly competes with Devyser's hereditary cancer, CFTR, and prenatal offerings to clinical labs.
• Myriad Genetics: Myriad offers hereditary cancer (BRCA, Lynch), prenatal (Prequel NIPT), and molecular diagnostics. It overlaps with Devyser on BRCA NGS, Lynch syndrome testing, and reproductive health screening sold to clinical labs and providers.
• Natera: Natera is a DNA-based testing company with Prospera dd-cfDNA for transplant monitoring, Vistara for NIPT, and Empower for hereditary cancer. It directly overlaps Devyser across transplant, reproductive health, and hereditary disease segments using cfDNA and NGS technologies.

Broad incumbents

• QIAGEN: QIAGEN is a global molecular diagnostics and sample-preparation technology company with broad IVD, PCR, and NGS-adjacent offerings. While not specialized in transplant, it serves the same clinical lab customers as Devyser with overlapping reagent and assay products.
• NeoGenomics: NeoGenomics is a US-based oncology and molecular diagnostics laboratory and kit provider. It overlaps with Devyser on hereditary cancer (BRCA, Lynch) NGS kits and on clinical testing services for transplant and oncology through its lab footprint.
• Revvity: Revvity (formerly PerkinElmer Life Sciences) provides genetic screening reagents, newborn screening platforms, and reproductive health diagnostics. Its maternal-fetal health and clinical lab reagent offerings overlap with Devyser's prenatal and hereditary disease kit portfolio.
• Bio-Techne: Bio-Techne's Diagnostics & Genomics segment sells molecular biology reagents, exo-RNA and protein assays, and diagnostic kits to clinical and research labs. Its reagent catalog and clinical lab partnerships overlap with Devyser's NGS-based diagnostic workflow offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/devyser
• Facebookfacebook.com/Devyser-105302922292797
• LinkedInlinkedin.com/company/devyser-ab
• Instagraminstagram.com/devyser

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Devyser