Kit for detecting HER2 gene amplification

Abstract

The invention relates to a kit for detecting breast cancer HER2 gene amplification, especially to a kit for detecting HER2 gene real-time fluorescence polymerase chain reaction. By the utilization of the real time fluorescence PCR technology, the kit provided by the invention detects the amplification level of the HER2 gene in a breast cancer tissue specimen by calculating Delta Ct value, and canbe applied in a plurality of research fields such as the auxiliary diagnosis, clinic and prognosis of breast cancer.

Description

technical field [0001] The invention relates to a breast cancer HER2 gene amplification detection kit, in particular to a HER2 gene real-time fluorescent polymerase chain reaction detection kit. This kit can detect the level of HER2 gene amplification, and can be widely used in auxiliary diagnosis of breast cancer caused by HER2 gene amplification, guidance of clinical medication, prognosis and other research fields. Background technique [0002] Breast cancer is the most common cancer in women worldwide, with 1 million new cases and nearly 400,000 deaths from breast cancer each year worldwide. According to the 2006 cancer incidence and top ten malignant tumor incidence rankings in my country provided by the Cancer Prevention and Control Office of the Ministry of Health, breast cancer ranks first among female malignant tumors, and the age of onset tends to be younger. Although the current breast cancer treatment has been developed by leaps and bounds, most of the treatment ...

AI Technical Summary

Problems solved by technology

The current immunohistochemical (IHC) detection method widely carried out in hospitals cannot completely and correctly judge the status of HER2 in patients

Because even about 10% of IHC (3+) patients do not have HER2 gene amplification, and these patients cannot benefit from the treatment of Herceptin, which not only causes high economic losses, but also delays the application of other programs Opportunity

In IHC (0) and (1+), there are nearly 10% false negatives, and for these patients, the opportunity to obtain an effective treatment plan will be lost.

In the 2007 first edition of the "Breast Cancer Clinical Practice Guidelines (China Edition)", the HER2 detection principles pointed out that IHC method or FISH technology can be used for the first assessment of tumor HER2 gene amplification status, and the IHC detection results are borderline samples (such as IHC++) should be re-tested by other methods that have been verified (such as FISH), but only a few hospitals in China are capable of carrying out this test, and FISH testing reagents are monopolized by foreign companies, the price is very expensive, and most patients cannot Bear such a high cost of testing, and lose the opportunity to obtain accurate and standardized test results

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