SelfDiagnostics
Selfdiagnostics is an innovative medical diagnostics company specializing in rapid, accurate, and easy-to-use testing solutions for infectious diseases, including COVID-19 and sexually transmitted infections. The company develops portable, pocket-sized, and instrument-free tests that combine laboratory-grade precision with the convenience of home or point-of-care testing. With a strong focus on research, development, and mass production, Selfdiagnostics aims to revolutionize diagnostics by making high-quality testing accessible, scalable, and affordable worldwide.
Industries
Nr. of Employees
small (1-50)
SelfDiagnostics
Veerenni 40a, 10138 Tallinn, Estonia
Products
Disposable instrument-free nucleic acid point-of-care test (single-use)
Single-use, pocket-sized molecular NAAT intended to detect pathogens at point of care without a dedicated instrument; described as ambient-stable with rapid turnaround (~45 minutes).
Multiplexed molecular home/point-of-care test for sexually transmitted infections
Multiplex nucleic-acid test for detection of common STIs (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae) designed for homecare and point-of-care use in a disposable format.
Lateral-flow serology rapid test (IgM/IgG)
Lateral-flow immunoassay for qualitative detection of IgM and IgG antibodies in capillary or venous blood with rapid turnaround for point-of-care use.
Lateral-flow antigen rapid test (professional use)
Antigen lateral-flow rapid test for detection of infectious individuals from nasal swab samples with short turnaround suitable for workplace and clinical screening.
Disposable instrument-free nucleic acid point-of-care test (single-use)
Single-use, pocket-sized molecular NAAT intended to detect pathogens at point of care without a dedicated instrument; described as ambient-stable with rapid turnaround (~45 minutes).
Multiplexed molecular home/point-of-care test for sexually transmitted infections
Multiplex nucleic-acid test for detection of common STIs (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae) designed for homecare and point-of-care use in a disposable format.
Lateral-flow serology rapid test (IgM/IgG)
Lateral-flow immunoassay for qualitative detection of IgM and IgG antibodies in capillary or venous blood with rapid turnaround for point-of-care use.
Lateral-flow antigen rapid test (professional use)
Antigen lateral-flow rapid test for detection of infectious individuals from nasal swab samples with short turnaround suitable for workplace and clinical screening.
Services
Set up and operation of automated pilot production lines for assembly of microfluidic cartridges, reagent integration and packaging aimed at cost-efficient high-volume output.
R&D services for assay design, microfluidic integration, reagent formulation, prototyping and preclinical testing for point-of-care molecular and lateral-flow assays.
Consultative support for analytical and clinical validation activities and device registration processes in European device registries and CE-marking pathways.
Establishment and management of regional distributor networks and channel partnerships to enable product roll-out across multiple regions.
Set up and operation of automated pilot production lines for assembly of microfluidic cartridges, reagent integration and packaging aimed at cost-efficient high-volume output.
R&D services for assay design, microfluidic integration, reagent formulation, prototyping and preclinical testing for point-of-care molecular and lateral-flow assays.
Consultative support for analytical and clinical validation activities and device registration processes in European device registries and CE-marking pathways.
Establishment and management of regional distributor networks and channel partnerships to enable product roll-out across multiple regions.
Expertise Areas
- Point-of-care molecular diagnostics
- Microfluidic cartridge and chip engineering
- Reagent formulation and stabilization for disposables
- Assay development for infectious diseases (multiplex molecular and lateral-flow)
Key Technologies
- Instrument-free nucleic acid amplification
- Isothermal and PCR-based amplification methods
- Microfluidics for sample handling and assay integration
- Reagent pellet/stabilized reagent formats
News & Updates
Selfdiagnostics will be presenting at Medica 2023 in Düsseldorf, Germany, from November 13-16, 2023, showcasing their latest point-of-care diagnostic tests.
Selfdiagnostics will present a poster session on rapid and precise RNA/DNA detection using their Multitest technology at the Medical Biodefense Conference 2023.
Selfdiagnostics has set up a production line in Germany to manufacture 1 million devices annually for COVID-19 testing.
Selfdiagnostics was recognized as a promising MedTech company at the Molecular Diagnostics Conference in San Francisco in 2017.
FIND, a partner of WHO, included Selfdiagnostics in their 2017-2020 pipeline for tuberculosis diagnostics, highlighting its potential for non-invasive, rapid TB detection.
The European Commission experts evaluated Selfdiagnostics' Horizon 2020 project positively, confirming progress towards bringing a non-instrumented nucleic acid amplification test device to the market.
Selfdiagnostics will be presenting at Medica 2023 in Düsseldorf, Germany, from November 13-16, 2023, showcasing their latest point-of-care diagnostic tests.
Selfdiagnostics will present a poster session on rapid and precise RNA/DNA detection using their Multitest technology at the Medical Biodefense Conference 2023.
Selfdiagnostics has set up a production line in Germany to manufacture 1 million devices annually for COVID-19 testing.
Selfdiagnostics was recognized as a promising MedTech company at the Molecular Diagnostics Conference in San Francisco in 2017.
FIND, a partner of WHO, included Selfdiagnostics in their 2017-2020 pipeline for tuberculosis diagnostics, highlighting its potential for non-invasive, rapid TB detection.
The European Commission experts evaluated Selfdiagnostics' Horizon 2020 project positively, confirming progress towards bringing a non-instrumented nucleic acid amplification test device to the market.