SelfDiagnostics
SelfDiagnostics is an Estonian-founded molecular diagnostics company that develops single-use, instrument-free PCR-grade point-of-care tests based on proprietary NINAAT technology, serving healthcare professionals, individual consumers, institutions, and defense end-markets across Europe, the US, and Asia.
- Company typePrivate
- Founded2008
- HeadquartersTallinn, Estonia
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What SelfDiagnostics does
SelfDiagnostics is an Estonian-founded (2008) and German-manufactured point-of-care molecular diagnostics company developing rapid, instrument-free PCR-grade tests for infectious diseases. The company is built around its proprietary NINAAT (Non-Instrument Nucleic Acid Amplification) platform, which combines isothermal amplification (LAMP), a proprietary microfluidic core chip, and immunochromatographic detection into a single-use device slightly larger than a credit card that delivers laboratory-grade accuracy in approximately 45 minutes without requiring instruments, maintenance, calibration, or skilled personnel. The product portfolio spans the Multitest COVID-19 test (CE marked September 2022), the Multitest CT/NG STD test, a Universal Multitest platform for customizable pathogen and biothreat detection, and the Credo Diagnostics VitaPCR and VitaSIRO solo cartridge-based PCR systems launched in January 2025.
SelfDiagnostics firmographics
Firmographics- Name
- SelfDiagnostics
- Legal name
- SelfDiagnostics OÜ
- Website
- https://selfdiagnostics.eu
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- SelfDiagnostics is an Estonian-founded molecular diagnostics company that develops single-use, instrument-free PCR-grade point-of-care tests based on proprietary NINAAT technology, serving healthcare professionals, individual consumers, institutions, and defense end-markets across Europe, the US, and Asia.
- Ownership category
- akta.pro rank
SelfDiagnostics industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges) (HLAHAOAI)
- akta.pro secondary industries
- Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
Keywords
Where SelfDiagnostics is headquartered
LocationHeadquarters
- HQ city
- Tallinn
- HQ country
- Estonia
- HQ region
- Europe
Offices2 records
Markets served
SelfDiagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Test Devices Sales: Sale of single-use rapid molecular diagnostic test devices including Multitest COVID-19, STD Multitest CT/NG, and Universal Multitest platform. Each test runs independently with no instrument investment required.
- Medical Devices and Consumables: Distribution and sale of third-party medical diagnostic products and devices including INSTI HIV/Syphilis/HCV tests, inhalators, and rapid test strips.
- Research and Development Services: Collaborative R&D projects with academic and industrial partners funded through grants from European Commission (Horizon 2020), Enterprise Estonia, and Saxony Development Bank.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Contact-based pricing for rapid molecular diagnostic tests |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels5 records
SelfDiagnostics product offering
Product offeringCore offering
SelfDiagnostics develops and manufactures portable, pocket-sized molecular diagnostic test devices based on its proprietary NINAAT (Non-Instrument Nucleic Acid Amplification) technology, combining isothermal amplification (LAMP), a microfluidic core chip, and immunochromatographic detection. The company produces single-use rapid tests such as Multitest COVID-19, Multitest CT/NG (STD Multitest), and a Universal Multitest platform, delivering PCR-grade accuracy in approximately 45 minutes without laboratory instruments or trained personnel. Manufacturing is conducted at its Leipzig, Germany facility with a target capacity of one million devices annually.
Product overview
SelfDiagnostics is a molecular diagnostics company offering point-of-care rapid tests based on proprietary NINAAT technology. The core product portfolio consists of the Multitest platform family including Multitest COVID-19 (portable PCR-grade test for SARS-CoV-2), Multitest CT/NG (STD rapid test for Chlamydia and Gonorrhea), and Universal Multitest (customizable platform for RNA/DNA detection of various pathogens). The company also distributes third-party diagnostic products including INSTI® brand HIV, HCV, and Syphilis tests, and medical devices such as inhalers and nebulizers. Additional products include the VitaPCR™ and VitaSIRO solo™ platforms from Credo Diagnostics for real-time PCR testing. The technology is protected by 7 patent families globally and is engineered and manufactured in Germany.
Differentiator
Problem solved
Functional benefit
Brands
- Multitest: A portable and pocket-sized PCR-grade rapid molecular test platform for detection of various pathogens including SARS-CoV-2 and STDs.
- Multitest COVID-19
- Multitest CT/NG
- Universal Multitest
- VitaPCR
- VitaSIRO solo
- Credo Diagnostics
Products and services
- Selfdiagnostics Multitest COVID-19 A portable, pocket-sized rapid molecular NAAT test that detects SARS-CoV-2 with PCR-grade accuracy in 45 minutes. Combines ease of use of rapid tests with diagnostic accuracy of laboratory PCR, with 97% sensitivity and 100% specificity compared to FDA EUA approved PCR tests.
- Multitest CT/NG (STD Multitest) A painless molecular rapid test for men and women to simultaneously detect Chlamydia Trachomatis and Neisseria Gonorrhoeae using NINAAT technology. Provides results in less than an hour from urine sample without laboratory equipment.
- Universal Multitest An open, customizable testing platform for detection of any RNA/DNA targets from infections to biothreat agents. Uses LAMP and immunochromatographic detection. Instrument-free, no external power needed. Detects targets including Chlamydia trachomatis, Neisseria gonorrhoeae, SARS-CoV-2, and Yersinia pestis.
- SARS-CoV-2 IgM/IgG Antibody Assay Kit A rapid point-of-care test kit that qualitatively detects IgM and IgG antibodies against SARS-CoV-2 from finger-stick blood, venipuncture whole blood, plasma, or serum. Results in 15 minutes with 99% specificity.
- VitaPCR Real-time PCR diagnostic tool delivering results in 20 minutes from sample to result at point of care. Based on polymerase chain reaction technology with higher accuracy than conventional rapid tests.
- VitaSIRO solo Standalone platform integrating nucleic acid extraction and real-time PCR in a cartridge-based design. Features extended multiplex capability detecting up to 6 targets from various sample types.
- Tuberculosis Test Lab-level accurate and fully disposable rapid self-test for tuberculosis detection using molecular diagnostics technology. Acknowledged by FIND (WHO co-op partner) as a key solution in TB fighting, included in their 2017-2020 project pipeline.
Quantifiable outcome
- 97% Sensitivity and 100% Specificity compared to FDA EUA approved PCR tests for SARS-CoV-2 detection
- +4 more outcomes
Companies that use SelfDiagnostics
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles4 records
SelfDiagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
SelfDiagnostics partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered minor and core.
- ELIKO Competence CenterminorPartnering on Internet of Things driven industrial R&D programme (EU48693) for prototyping NINAAT-based point-of-care device for detection of infectious diseases.
- University of TartucoreCollaborative R&D partnership for development of inhibitor tolerant DNA polymerase for application in isothermal amplification. Applied research in smart specialisation growth areas enabling long-term collaboration with academic institutions.
- Fraunhofer Institute for Cell Therapy and Immunology (IZI)corePartnership for continuous R&D and validation with access to top European virology labs. Collaboration on development and manufacture of innovative testing technologies.
- Dresden University of TechnologyminorAcademic partnership for R&D and validation of diagnostic technologies.
- Tallinn University of Technology (TalTech)minorAcademic partnership for R&D and validation of diagnostic technologies.
Scale indicators6 records
Recent moves9 records
Expansion highlights5 records
SelfDiagnostics competitors and assessment
Company assessmentBroad incumbents
- QIAGEN (QIAstat-Dx): QIAGEN's QIAstat-Dx delivers multiplex syndromic molecular testing for respiratory and GI pathogens at the point of care. A broad incumbent in molecular diagnostics with global distribution; competes in the multiplex molecular panel space where SelfDiagnostics also positions.
- bioMérieux (BioFire): BioFire FilmArray and SpotFire systems deliver multiplex syndromic molecular testing (respiratory, GI, meningitis/encephalitis panels) at the point of care. A direct comparable on multiplex molecular capability, though BioFire requires an instrument and targets hospital labs more than decentralized/home use.
- Abbott (ID NOW): Abbott's ID NOW platform is a rapid molecular POC system delivering influenza, strep A, and SARS-CoV-2 results in minutes. A broad incumbent in rapid molecular diagnostics with global reach; SelfDiagnostics competes on PCR-grade accuracy at lower price points in similar use cases (clinics, urgent care, mass events).
- Cepheid (Danaher): Danaher-owned Cepheid is the dominant player in point-of-care molecular diagnostics with the GeneXpert system, running PCR tests for infectious diseases including CT/NG, SARS-CoV-2, and TB. Directly comparable as the instrument-based incumbent SelfDiagnostics competes against, though Cepheid requires a benchtop instrument while SelfDiagnostics is instrument-free.
Direct peers
- Cue Health: Cue Health developed a connected, cartridge-based molecular POC platform for at-home and professional SARS-CoV-2 and respiratory testing. Closely comparable as a portable molecular POC company pursuing both consumer and enterprise channels, though Cue relies on a connected reader versus SelfDiagnostics' instrument-free architecture.
- OraSure Technologies: OraSure Technologies develops and distributes rapid at-home and point-of-care diagnostic tests including HIV, HCV, and COVID-19 products. Comparable as a peer in decentralized infectious disease testing with overlapping home-test and POC channels, though OraSure's core menu is immunoassay-based rather than molecular.
- Credo Diagnostics: Credo Diagnostics (whose VitaPCR and VitaSIRO solo products SelfDiagnostics distributes) is a molecular POC company offering cartridge-based real-time PCR systems. Directly comparable as a peer whose products are integrated into SelfDiagnostics' own portfolio, serving overlapping customers with similar rapid molecular workflows.
Others
- Mesa Labs: Mesa Labs provides testing, calibration, and quality control services and products for the healthcare and life sciences industries. Adjacent to SelfDiagnostics as an instrument/device vendor serving diagnostics and clinical customers, though focused on QC/calibration rather than molecular assay development.
Emerging players
- Molecular Designs: Molecular Designs (a Hologic spinout partnership) develops rapid isothermal molecular diagnostics for respiratory and sexually transmitted infections. Comparable as an emerging molecular POC company with overlapping infectious disease menu and similar target customers.
- QuantuMDx: QuantuMDx develops the Q-POC portable molecular diagnostic platform targeting infectious disease and antimicrobial resistance testing at the point of care. Closely comparable as an emerging European player pursuing decentralized PCR-grade testing with similar use cases (clinical, field, biodefense).
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
SelfDiagnostics social profiles
Digital presenceSelfDiagnostics compliance and trust
Trust signalCompliance4 records
SelfDiagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
SelfDiagnostics leadership team
Management profileNumber of profiles
Profiles3 records
SelfDiagnostics subsidiaries and ownership
Company hierarchySubsidiaries1 record
SelfDiagnostics funding detail
Funding detailFunding overview
Funding rounds8 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SelfDiagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SelfDiagnostics
What does SelfDiagnostics do?
SelfDiagnostics develops and manufactures portable, pocket-sized molecular diagnostic test devices based on its proprietary NINAAT (Non-Instrument Nucleic Acid Amplification) technology, combining isothermal amplification (LAMP), a microfluidic core chip, and immunochromatographic detection. The company produces single-use rapid tests such as Multitest COVID-19, Multitest CT/NG (STD Multitest), and a Universal Multitest platform, delivering PCR-grade accuracy in approximately 45 minutes without laboratory instruments or trained personnel. Manufacturing is conducted at its Leipzig, Germany facility with a target capacity of one million devices annually.
Is SelfDiagnostics a public or private company?
SelfDiagnostics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was SelfDiagnostics founded?
SelfDiagnostics was founded in 2008. It employs 11 to 50 people.
Where is SelfDiagnostics based?
SelfDiagnostics is headquartered in Tallinn, Estonia, in the Europe region.
How does SelfDiagnostics make money?
Three revenue lines are on record. Diagnostic Test Devices Sales are the primary driver. The others are medical Devices and Consumables and research and Development Services.
Who are SelfDiagnostics's main competitors?
Broad incumbents on record are QIAGEN (QIAstat-Dx), bioMérieux (BioFire), Abbott (ID NOW) and Cepheid (Danaher). Direct peers are Cue Health, OraSure Technologies and Credo Diagnostics. Mesa Labs is listed as an others. Emerging players are Molecular Designs and QuantuMDx.
Does SelfDiagnostics have an API?
No public API is recorded for SelfDiagnostics.
What industry is SelfDiagnostics in?
SelfDiagnostics's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAHAOAI, Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges), with a secondary code of HLAAALAL, Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays). Its NAICS code is 325413 and its SIC code is 2835.