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IVD kits for oncology

In the category of CE IVD kits for oncology, we present our comprehensive portfolio of products for one-step real-time RT-PCR detection and quantification of BCR-ABL1 fusion transcripts.

The BCR-ABL1 hybrid gene is the main product of the t(9;22)(q34;q11) translocation. Depending on the breakpoint in the BCR gene, three variants of the fusion gene have been characterized: MAJOR (M-bcr, e14a2, e13a2, also known as b3a2, b2a2), MINOR (m-bcr, e1a2), and MICRO (mu-bcr, e19a2, also known as c3a2). BCR-ABL1 transcripts are translated to the corresponding proteins: p210 (major), p190 (minor), and p230 (micro).

The MAJOR variant of BCR-ABL1 gene is found in more than 90 % of patients suffering from chronic myelogenous leukemia (CML). To monitor minimal residual disease (MMR), BCR-ABL1 transcripts are quantified to the copy number of the reference gene transcript (ABL1, GUSB). Efforts to standardize molecular monitoring of BCR-ABL1 MAJOR led to introduction of the laboratory recommendations (Cross at al., 2015) and to development of the international reporting scale (IS) which allows accurate comparison of results obtained by different laboratories.

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 BCR-ABL MAJOR / GUSB

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 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.

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 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 ONCO EGFR T790M

gb ONCO EGFR (T790M) kit enables the detection and quantification of the EGFR T790M (2369C>T, rs121434569) somatic mutation in the human genomic DNA. The detection principle is based on real-time PCR methodology with the use of fluorescently labeled probes and allele-specific primers. The kit contains all components necessary to perform the analysis.

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.

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 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.