BIOPIX-T
Biopix-T is a molecular diagnostics company founded in December 2019, specializing in the development and manufacturing of portable and scalable diagnostic devices and assays for infectious diseases and companion diagnostics. The company aims to revolutionize point-of-care and home testing with innovative, affordable, and user-friendly solutions, and aspires to become a global leader in molecular diagnostics.
Industries
Nr. of Employees
small (1-50)
Products
Portable isothermal amplification instrument for point-of-care testing
Compact, low-power instrument that performs real-time colorimetric isothermal nucleic-acid amplification for decentralized diagnostic testing; smartphone-controlled and designed for field and home use.
Isothermal amplification test kits for infectious agents (IVD and research formats)
Diagnostic reagent kits for nucleic-acid detection of pathogens (examples include assays for SARS-CoV-2 and Influenza A and malaria agents) compatible with portable isothermal instruments and standard amplification platforms.
Research-use universal mastermix for LAMP
Pre-formulated mastermix containing polymerase, reverse transcriptase, dNTPs, buffers and colorimetric dye for LAMP assays; provided for research use and customizable to specific targets.
Portable isothermal amplification instrument for point-of-care testing
Compact, low-power instrument that performs real-time colorimetric isothermal nucleic-acid amplification for decentralized diagnostic testing; smartphone-controlled and designed for field and home use.
Isothermal amplification test kits for infectious agents (IVD and research formats)
Diagnostic reagent kits for nucleic-acid detection of pathogens (examples include assays for SARS-CoV-2 and Influenza A and malaria agents) compatible with portable isothermal instruments and standard amplification platforms.
Research-use universal mastermix for LAMP
Pre-formulated mastermix containing polymerase, reverse transcriptase, dNTPs, buffers and colorimetric dye for LAMP assays; provided for research use and customizable to specific targets.
Services
Clinical validation and study coordination
Planning and conducting sensitivity/specificity studies and multi-center clinical validations for diagnostic instruments and assays.
Technology transfer and manufacturing support
On-site training and transfer of production processes to local manufacturing partners to enable regional kit and device production.
Regulatory and quality management support
Implementation and maintenance of QMS/ISMS practices and support for IVD conformity (ISO 13485, ISO/IEC 27001, IVDR/CE notification) relevant to diagnostic devices and kits.
Distribution and commercialization partnerships
Establishment of regional distributor relationships and commercial partnerships to enable market entry and local sales channels.
Clinical validation and study coordination
Planning and conducting sensitivity/specificity studies and multi-center clinical validations for diagnostic instruments and assays.
Technology transfer and manufacturing support
On-site training and transfer of production processes to local manufacturing partners to enable regional kit and device production.
Regulatory and quality management support
Implementation and maintenance of QMS/ISMS practices and support for IVD conformity (ISO 13485, ISO/IEC 27001, IVDR/CE notification) relevant to diagnostic devices and kits.
Distribution and commercialization partnerships
Establishment of regional distributor relationships and commercial partnerships to enable market entry and local sales channels.
Expertise Areas
- Point-of-care molecular diagnostics
- Isothermal amplification assay development (LAMP/qcLAMP)
- Reagent formulation for nucleic-acid amplification
- Clinical validation and diagnostic performance studies
Key Technologies
- Loop-mediated isothermal amplification (LAMP)
- Real-time colorimetric quantitative detection
- Portable point-of-care diagnostic instruments
- Smartphone-controlled device interfaces (Android/iOS)