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IVD kits for oncology

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.

In the category of CE IVD kits for oncology we offer an NGS kit as well. It is intended for next generation sequencing based detection of specific gene aberrations playing an important role in therapy strategy for selected diagnoses.

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gb ONCO BCR-ABL MAJOR gb ONCO BCR-ABL MAJOR

gb ONCO BCR-ABL MAJOR gb ONCO BCR-ABL MAJOR

The CE IVD real-time PCR kit enables detection and quantification of the major transcripts of b2a2 and b3a2 of the abberant chromosome BCR-ABL1. The examination is based on one-step RT-qPCR using fluorescently labeled probes. Quantification of both fusion and reference transcript is processed in one tube.

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gb ONCO BCR-ABL MINOR / ABL gb ONCO BCR-ABL MINOR / ABL

gb ONCO BCR-ABL MINOR / ABL 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.

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New
gb ONCO BCR-ABL MICRO / ABL gb ONCO BCR-ABL MICRO / ABL

gb ONCO BCR-ABL MICRO / ABL 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.

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STANDARD MMR BCR-ABL MAJOR STANDARD MMR BCR-ABL MAJOR

STANDARD MMR BCR-ABL MAJOR STANDARD MMR BCR-ABL MAJOR

STANDARD MMR BCR-ABL MAJOR is an RNA standard representing a defined ratio of BCR-ABL1 in MAJOR (b3a2) on the background of the ABL1 and GUSB reference gene at the major molecular response level (MMR). To convert the BCR-ABL1 MAJOR results to IS, it is necessary to include the STANDARD in to the own analysis and the results analysis.

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gb ONCO JAK2 (V617F) gb ONCO JAK2 (V617F)

gb ONCO JAK2 (V617F) gb ONCO JAK2 (V617F)

The IVD 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.

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gb ONCO BRAF (V600E) gb ONCO BRAF (V600E)

gb ONCO BRAF (V600E) gb ONCO BRAF (V600E)

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

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gb ONCO CLL gb ONCO CLL

gb ONCO CLL 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.

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ngs ONCO anti-EGFR ngs ONCO anti-EGFR

ngs ONCO anti-EGFR ngs ONCO anti-EGFR

This kit is intended for target amplification of hot-spot areas in selected oncogenes relevant for target therapy of oncological patients (colorectal cancer, non-small cell lung cancer). It is designed to prepare a library of samples for sequencing on the Illumina MiSeq® platform. The kit includes free use of the very user-friendly ERMI evaluation software.

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gb ONCO BCR-ABL DETECT gb ONCO BCR-ABL DETECT

gb ONCO BCR-ABL DETECT 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.

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gb ONCO EGFR T790M gb ONCO EGFR T790M

gb ONCO EGFR T790M gb ONCO EGFR T790M

The CE IVD real-time PCR kit gb ONCO EGFR T790M enables detection and quantitation of the EGFR T790M (2369C> T, rs121434569) somatic mutation in human DNA. The epidermal growth factor receptor (EGFR) belongs to the tyrosine kinase receptor family.

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