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 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.

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 ONCO BRAF (V600)

The kit is used to detect and quantify the BRAF V600E, E2, D, D2, K, R and M somatic mutations in human genomic DNA. The principle of detection is based on real-time PCR methodology with the use of fluorescently labelled probes and allele-specific primers. The kit contains all components necessary to perform the analysis.

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.