What altona Diagnostics GmbH does

altona Diagnostics GmbH is a privately held German molecular diagnostics company headquartered in Hamburg that develops and manufactures real-time PCR-based in vitro diagnostic test kits for the detection of viruses, bacteria, and parasites. Founded around 1998 and operating for over 25 years in the molecular diagnostics business, the company offers a catalog of more than 50 CE-IVD marked kits organized across the RealStar, AltoStar, ExtraStar, and FlexStar sub-brands and six pathogen panels (Bloodborne, Fever/Tropical/Emerging, Gastrointestinal, Respiratory, STI, Transplant and immunocompromised). Its flagship integrated offering is the AltoStar Molecular Diagnostic Workflow, which bundles proprietary instrumentation (Automation System AM16), nucleic acid extraction chemistry, and AltoStar Connect software into an automated end-to-end solution compatible with multiple open real-time PCR platforms from Roche, Bio-Rad, Applied Biosystems, QIAGEN, and Siemens.

Revenue is generated through one-time sales of diagnostic kits to clinical and medical laboratories worldwide, using a hybrid go-to-market model that combines 10 wholly-owned subsidiaries in Argentina, Brazil, Canada, France, India, Italy, Mexico, Poland, the United Kingdom and the USA with more than 40 distribution partners and regional sales representatives covering Africa, Asia-Pacific, Europe (East/North/West), Latin America, the Middle East, and North America. The company additionally supplies filovirus assays directly to international organizations (WHO, ASLM) and government health agencies in outbreak-affected regions, including the DRC and Uganda, using temperature-controlled logistics. It is ISO 13485 certified and its AltoStar line is prepared under the new EU IVDR; the company is privately owned by its General Managers Dr. Sönke Friedrichsen and Hans Kuhn, is profitable, and is self-funded with no disclosed venture capital or private equity backing.

Name

altona Diagnostics GmbH

Legal name

altona Diagnostics GmbH

Website

https://altona-diagnostics.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

altona Diagnostics GmbH is a privately held Hamburg-based molecular diagnostics company that develops and sells CE-IVD marked real-time PCR test kits and the AltoStar automated workflow to clinical laboratories, reference labs, and outbreak-response agencies in over 40 countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

akta.pro secondary industries

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Molecular diagnostics kits
• Real-time PCR assays
• In vitro diagnostics
• Pathogen detection kits
• Automated PCR workflow

Headquarters

HQ city

Hamburg

HQ country

Germany

HQ region

Europe

Offices11 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. PCR Diagnostic Kit Sales: altona Diagnostics generates revenue through the sale of in vitro diagnostic PCR test kits. The company manufactures and sells ready-to-use molecular diagnostic test kits based on real-time PCR technology to medical laboratories globally through subsidiaries and distribution partners. Products include CE-IVD marked kits for clinical use and RUO (research use only) kits for research applications.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

altona Diagnostics GmbH develops, manufactures, and commercializes real-time PCR-based in vitro diagnostic test kits for the detection of pathogens including viruses, bacteria, and parasites. The company sells CE-IVD marked and RUO (research use only) reagent kits under the RealStar, ExtraStar, and FlexStar brands, complemented by the AltoStar Molecular Diagnostic Workflow—an automated solution combining instrumentation, nucleic acid extraction chemistry, and dedicated software.

Product overview

altona Diagnostics develops and manufactures in vitro diagnostic tests for PCR-based detection of pathogens including viruses, bacteria, and parasites. The company's product portfolio consists of the AltoStar® Molecular Diagnostic Workflow (automated solution with instrumentation, reagents, consumables, and software) and three reagent brands (RealStar®, ExtraStar®, and FlexStar®). RealStar® offers over 50 CE-IVD marked kits and RUO reagents across pathogen panels including Bloodborne, Fever/Tropical/Emerging (FTE), Gastrointestinal, Respiratory, STI, and Transplant/Immunocompromised. ExtraStar® and FlexStar® provide additional PCR-based diagnostic reagents. Products are compatible with open real-time PCR platforms and the proprietary AltoStar® automated workflow. The company sells globally through subsidiaries and over 40 distribution partners.

Differentiator

Problem solved

Functional benefit

Brands

• AltoStar®: Automated molecular diagnostic workflow solution including instrumentation, reagents, consumables, and software
• ExtraStar®
• FlexStar®
• RealStar®

Products and services

• AltoStar Molecular Diagnostic Workflow Automated molecular diagnostic workflow solution combining instrumentation, nucleic acid extraction chemistry, dedicated software, and consumables for clinical and medical laboratories performing PCR-based pathogen detection.
• RealStar PCR Kits PCR-based in vitro diagnostic test reagent kits for detection of viruses, bacteria, and parasites, covering bloodborne, fever/tropical/emerging, gastrointestinal, respiratory, STI, and transplant pathogen panels. Over 50 CE-IVD marked kits and additional RUO kits.
• ExtraStar PCR Reagents PCR-based in vitro diagnostic reagent product line for laboratories performing pathogen detection testing.
• FlexStar Multiplex PCR Kits Multiplex PCR-based in vitro diagnostic test reagents enabling detection of multiple pathogens in a single test for clinical and medical laboratories.
• RealStar Bundibugyo Virus RT-PCR Kit 1.0 (RUO) Reagent system based on real-time PCR technology for qualitative detection of Bundibugyo ebolavirus (BDBV) specific RNA. 96 reactions, research use only, for reference laboratories and outbreak-response stakeholders.
• RealStar Filovirus Screen RT-PCR Kit 1.0 (RUO) Reagent system based on real-time PCR technology for qualitative detection and differentiation of Ebola- and Marburgvirus specific RNA. 96 reactions, research use only.
• RealStar Filovirus Type RT-PCR Kit 2.0 (RUO) Reagent system based on real-time PCR technology for qualitative detection and differentiation of filovirus RNA including five Ebolavirus species: Bundibugyo, Reston, Sudan, Tai Forest, and Zaire. Research use only.
• RealStar Hantavirus-HFRS RT-PCR Kit 1.0 (RUO) Reagent system based on real-time PCR technology for qualitative detection and differentiation of RNA specific for hantavirus causing hemorrhagic fever with renal syndrome (HFRS), including Dobrava-Belgrade, Seoul, Hantaan, and Puumala viruses.
• RealStar Hantavirus-HPS RT-PCR Kit 1.0 (RUO) Reagent system based on real-time PCR technology for qualitative detection of RNA specific for hantavirus causing pulmonary syndrome (HPS). Research use only.
• FlexStar Mp & CP Multiplex PCR kit for detection of pathogens causing non-specific pneumonia (Mycoplasma pneumoniae and Chlamydophila pneumoniae) for clinical laboratories.
• FlexStar Bordetella Multiplex PCR kit for detection of Bordetella pathogens causing whooping cough, for use in clinical and medical laboratories.
• AltoStar Automation System AM16 Automated instrument component of the AltoStar Molecular Diagnostic Workflow system used by laboratories to process PCR-based diagnostic tests.

Quantifiable outcome

• Development of dedicated Bundibugyo RT-PCR kit from internal project decision to first production lot completed in only six days
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration13 records

Feature7 records

Partnerships

Four partnerships are on record, tiered core and major.

• World Health Organization (WHO)coreStrategic or Co-development PartnerWHO declared the Ebola Bundibugyo outbreak a Public Health Emergency of International Concern (PHEIC). altona Diagnostics coordinates with WHO for supply of filovirus assays to outbreak-affected regions including DRC and Uganda.
• African Society for Laboratory Medicine (ASLM)coreStrategic or Co-development Partneraltona Diagnostics works with ASLM to coordinate supply of filovirus diagnostic products to laboratories across Africa during outbreak response efforts.
• Local African DistributorsmajorChannel Partner/ Reseller/ DistributorLocal African distribution partners have already ordered altona products and can supply laboratories in their markets directly, enabling rapid local access to diagnostic products.
• Institut National de la Recherche Biomédicale (INRB), KinshasacoreStrategic or Co-development PartnerINRB in Kinshasa, DRC used the RealStar Filovirus Screen RT-PCR Kit 1.0 to detect the currently circulating Bundibugyo virus variant in clinical samples during the May 2026 outbreak. Results were published in scientific literature confirming kit performance.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Others

• Roche Diagnostics:

Broad incumbents

• Cepheid (Danaher): Dan's GeneXpert closed-system molecular diagnostics platform dominates hospital-based PCR testing globally. Represents the integrated instrument-reagent model that altona's AltoStar workflow aspires to compete with; a key competitor for high-volume clinical lab accounts.
• Hologic: Diversified diagnostics and women's health company with a Panther/Panther Fusion molecular diagnostics system running a broad infectious-disease menu. Competes with altona for hospital and reference-laboratory molecular testing contracts in the US and Europe.
• Bio-Rad Laboratories: Major life-science instrument and reagent company whose CFX96 real-time PCR systems are listed as a validated platform for altona's kits. Bio-Rad also sells its own molecular diagnostic kits, making it both a partner (instrument platform) and competitor (reagent supplier) to altona.
• Becton Dickinson (BD): Global medical-technology company with the BD MAX and BD COR molecular diagnostic systems running open and closed PCR menus for clinical laboratories. A key competitor in hospital-based molecular diagnostics with broader scale than altona.

Direct peers

• Seegene: South Korea-based molecular diagnostics company specializing in multiplex real-time PCR reagents (Allplex assays) for syndromic pathogen panels. Comparable to altona's FlexStar multiplex franchise and broader RealStar menu, with similar clinical-laboratory customer base globally.
• QIAGEN: Global molecular diagnostics and sample-preparation company with a large real-time PCR reagent portfolio (e.g., QIAcuity digital PCR, QuantiFERON, artus PCR kits) and broad infectious-disease menu. Highly comparable to altona across PCR kit technology, customer base of clinical and reference labs, and global distribution.
• TIB Molbiol: Berlin-based specialist in PCR-based diagnostic kits with a deep menu of infectious-disease assays including filovirus, SARS-CoV-2, and tropical pathogens. Closest direct competitor to altona: same German origin, same PCR-only technology, same B2B clinical-laboratory channel.

Emerging players

• Genetic Signatures: Australian molecular diagnostics company with 3base technology for multiplexed PCR-based pathogen detection. Smaller and more specialized than altona but competes in similar clinical-laboratory molecular-diagnostic menus for infectious-disease testing.

Regional players

• Eurofins Scientific: Global laboratory testing services group that both runs PCR testing services and supplies diagnostic kits through subsidiaries. Eurofins is a potential altona customer (reference lab) in some markets and a competitor (in-house IVD reagent programs) in others, with strongest overlap in Europe.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UC54duPHV--Ir4F-UQosPozA
• LinkedInde.linkedin.com/company/altona-diagnostics

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries10 records

Funding overview

Funding rounds

Investors

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 altona Diagnostics GmbH