BCRABL gene fusion detection probe (BCR/ABL)

BCR/ABL Gene Fusion Probe Detection Kit

BCR-ABL is a mutation that is formed by the combination of two genes, known as BCR and ABL. It's sometimes called a fusion gene. The BCR gene is normally on chromosome number 22. The ABL gene is normally on chromosome number 9. The BCR-ABL mutation happens when pieces of BCR and ABL genes break off and switch places. The piece of chromosome 9 that breaks off includes part of the ABL gene. When this piece moves over to chromosome 22, part of the ABL gene attaches to the BCR gene. The merged gene is called the BCR-ABL fusion gene.  The changed chromosome 22, which contains the BCR-ABL gene, is called the Philadelphia chromosome because it is the city where researchers first discovered it. The BCR-ABL gene is not the type of mutation that is inherited from one parents. It is a type of somatic mutation, which means one is not born with it but can get it later in life.

The BCR-ABL gene shows up in patients with certain types of leukemia, a cancer of the bone marrow and white blood cells. BCR-ABL is found in almost all patients with a type of leukemia called chronic myeloid leukemia (CML). Another name for CML is chronic myelogenous leukemia. Both names refer to the same disease.

The BCR-ABL gene is also found in some patients with a form of acute lymphoblastic leukemia (ALL) and rarely in patients with acute myelogenous leukemia (AML).

Product Main Components

The kit consists of ABL orange probe and BCR green probe

Intended Usage

 This kit is mainly used for the detection of BCR/ABL gene fusion in vitro. The test samples are bone marrow cells suspected or diagnosed with leukemia patients (clinical or post-treatment patients) by clinical routine examination and used only for auxiliary diagnosis of the patient’s molecular typing. Leukemia is a kind of malignant clonal disease of hematopoietic stem cells. Clonal leukemic cells proliferate and accumulate in bone marrow and other hematopoietic tissues, and infiltrate other non-hematopoietic tissues and organs, because of an uncontrolled proliferation, differentiation and apoptosis, and inhibition of the normal hematopoietic function. BCR/ABL gene is a common cytogenetic anomaly in patients with chronic myelocytic leukemia (CML). The BCR/ABL fusion gene can be found in 90% of CML patients, and the prognosis of the patients with BCR/ABL gene is poor. This kit was validated against the BCR/ABL gene fusion detection performance only, and was not combined with the drug for clinical validation. This kit is only suitable for the detection of BCR/ABL gene fusion status, the test results are for clinical reference only and should not be used as the only basis for diagnosis. The clinician should make comprehensive judgment on the test results in combination with other clinical indicators.

Detection Principle

Fluorescence in situ hybridization is a technique for direct detection in vitro of specific nucleic acids in cells. According to the principle of complementary bases pairing, a specific probe is complementary to a target sequence within the cell. The probe and target sequence can be clearly observed under fluorescence microscope and under appropriate excitation light, due to the probe fluorescence. The kit uses orange fluorescein-labeled ABL probe and green fluorescein-labeled BCR probe. By in situ hybridization technique, the two probes bind to the target detection site. Normally (if BCR/ABL gene have not fused), two orange red signals and two green signals are shown under fluorescence microscope. When there is fusion, green and orange signals form by recombination a yellow fusion signal.

Certain cancer medicines are especially effective in treating leukemia patients with the BCR-ABL gene mutation. These medicines also have fewer side effects than other cancer treatments. The same medicines are not effective in treating different types of leukemia or other cancers.