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 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).

gb SARS-CoV-2 Variant E484K, L452R

Multiplex CE IVD kit enables detection of SARS-CoV-2 virus RNA and simultaneously the detection of mutations E484K and L452R 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).

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 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 JAK2 (V617F)

The real-time PCR kit is used for detection and quantification of somatic mutation V617F JAK2 gene in human genomic DNA. The detection principle is based on real-time PCR using fluorescently labeled probes and allele specific primers.

STANDARD MMR BCR-ABL MAJOR

STANDARD MMR BCR-ABL MAJOR represents RNA with the precisely defined copy number ratio of BCR-ABL1 MAJOR (b3a2) and reference genes ABL1 and GUSB transcripts. Major molecular response (MMR) corresponds to BCR-ABL1 0.1% International Scale (IS) transcript levels. STANDARD MMR BCR-ABL MAJOR is used to convert BCR-ABL1 values to IS.

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 ONCO BCR-ABL DETECT

The CE IVD real-time PCR kit is intended for a qualitative determination of a type of the BCR-ABL1 fusion gene alteration. Apart from commonly occurring fusions the kit detects rare alterations as well. Detection method based on one-step RT-qPCR ensures quick, less laborious and, above all, semiquantitative determination of the fusion type, while sophisticated system of controls ensures validity of the result and its adequate interpretation.