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
Tallinn, Harjumaa, Estonia, Europe
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
Pilot production and scale-up for diagnostic devices
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.
Assay development and prototyping (molecular and lateral flow)
R&D services for assay design, microfluidic integration, reagent formulation, prototyping and preclinical testing for point-of-care molecular and lateral-flow assays.
Regulatory and validation support
Consultative support for analytical and clinical validation activities and device registration processes in European device registries and CE-marking pathways.
Distribution and partnership management
Establishment and management of regional distributor networks and channel partnerships to enable product roll-out across multiple regions.
Pilot production and scale-up for diagnostic devices
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.
Assay development and prototyping (molecular and lateral flow)
R&D services for assay design, microfluidic integration, reagent formulation, prototyping and preclinical testing for point-of-care molecular and lateral-flow assays.
Regulatory and validation support
Consultative support for analytical and clinical validation activities and device registration processes in European device registries and CE-marking pathways.
Distribution and partnership management
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