IVD

We are an EN ISO 13485 certified EU-located company developing and producing CE IVD real-time PCR kits.

Our in vitro diagnostics fall into five categories: clinical genetics, hematology, pharmacogenetics, oncology and microbiology.

Our typical partners are end-users of the RT-PCR kits (mostly in CZ and SK), business partners and distributors. We are looking for business partners and/or distributors worldwide who can fit the portfolio of our products, either the whole or a part of it, to their sales strategy (see here).

Tiles List

gb ONCO BCR-ABL MAJOR / ABL

CE IVD diagnostic kit enables detection and quantification of b2a2 (e13a2) and b3a2 (e14a2) BCR-ABL1 MAJOR fusion gene transcript variants. The detection is based on one-step RT-qPCR using fluorescently labelled probes.

gb ONCO BRAF (V600E)

The CE IVD real-time PCR kit is used to detect and quantify the BRAF V600E, E2, D and D2 somatic mutations in human genomic DNA. The detection principle is based on real-time polymerase chain reaction (qPCR) using fluorescently labelled probes and allele specific primers.

gb ONCO CLL

The CE IVD real-time PCR kit is intended for prognosis assessment in CLL patients by analysis of cDNA (reverse transcribed RNA) samples of human B lymphocytes obtained from peripheral blood. The kit is based on reverse transcription together with quantitative real-time polymerase chain reaction (qRT-PCR) using fluorescently labelled probes.

gb ONCO BCR-ABL MICRO / ABL

The CE IVD real-time PCR kit enables the quantitative determination of the copy number ratio of the e19a2 (c3a2) transcript of the BCR-ABL1 fusion gene to the copy number of the ABL1 reference gene transcript.

gb ONCO BCR-ABL MINOR / ABL

The CE IVD real-time PCR kit enables the quantitative determination of the copy number ratio of the e1a2 transcript of the BCR-ABL1 fusion gene to the copy number of the ABL1 reference gene transcript.

gb GENETIC HLA-B*27

The kit enables the detection of HLA-B*27 allele in genomic DNA. Presence of the allele coding the HLA-B*27 anti-gene is strongly associated with ankylosing spondylitis (Bechterew's disease) and other inflammatory diseases. The HLA-B*27 allele is detected in the FAM channel and human genomic DNA, as an internal positive control, in the HEX channel.

gb Human B2M mRNA

The gb Human B2M mRNA kit enables the detection of human mRNA. Detection is based on the B2M gene (Gene ID 567). This gene encodes beta-2-microglobulin. It is a serum protein found in association with the major histocompatibility complex (MHC) class I heavy chain on the surface of nearly all nucleated cells (excludes red blood cells). The kit is intended to monitor the quality of RNA isolates from human biological material.

gb SARS-CoV-2 Multiplex

Multiplex CE IVD kit for detection of SARS-CoV-2 virus is based on one-step RT-qPCR using fluorescently labelled probes (FAM and HEX channels) and exogenous positive control (Cy5 channel). The detection method is based on officially recommended WHO and Institut Pasteur designs for detection of SARS-CoV-2 and usage of our proprietary GEMINI™ probe technology.

gb SARS-CoV-2 Combi

Combi CE IVD kit for detection of SARS-CoV-2 virus is based on one-step RT-qPCR using fluorescently labelled probes which allow the detection of viral genes E and RdRP in FAM channel and exogenous positive control in HEX channel. The detection method is based on officially recommended WHO and Institute Pasteur designs for detection of SARS-CoV-2 and usage of our proprietary GEMINI™ probe technology.

gb SARS-CoV-2 Influenza A/B

gb SARS-CoV-2 Influenza A/B CE IVD kit is based on one-step RT-qPCR using fluorescently labelled probes enabling a multiplex detection of viral genes of SARS-CoV-2, Influenza A and Influenza B. The detection method is based on officially recommended WHO and Institut Pasteur designs for detection of SARS-CoV-2 and on usage of our proprietary GEMINI™ probe technology.

gb SARS-CoV-2 Variant SA/BR, UK

Multiplex CE IVD kit for detection of SARS-CoV-2 virus and identification of its British (Alpha), South African (Beta) and Brazilian (Gamma) variants in one reaction. The kit is based on one-step RT-qPCR using fluorescently labelled probes (FAM, HEX, ROX channels) and exogenous positive control (Cy5 channel).