Description

TestGene’s kits for mutation in EGFR&KRAS genes detection serve a part of all such tests which are implemented in Russia. Those kits have successfully passed prequalification in European Molecular Genetics Quality Network (EGFR) and Pathologisches Institute (KRAS). Quality control was carried out on the basis of molecular diagnostic laboratory “Republican Clinical Oncology Center” of the Ministry of Health Care of the Republic of Tatarstan.

It is extremely important to detect mutation status of EGFR and KRAS while selecting a medication to be sure that patients are treated in accordance with the molecular features of the disease. The kits are completely free from disadvantages of other approaches, such as: the need for quantitative calibration of DNA sample, the presence of non-specific signal in the absence of mutation, subjectivity analysis of results, false positive results in cases of excess of the recommended amounts of test material.

The type of TaqMan technology used in the kits (based on destructible oligonucleotide probes with chemical modifications of locked nucleic acids) has a high sensitivity and specificity. Depending on the total amount of DNA in the sample, there is up to 1% of mutant against a background of wild DNA determined with an accuracy of at least 99,9%.

The features of the kits allow detecting reproducibly mutations presented even in low concentration and minimizing the probability of false-negative results. The kits are compatible with all common real-time PCR thermocyclers ABI 7300/7500/StepOne, Bio-Rad iQ5/CFX, Rotor-Gene 3000/6000, DT-prime and etc.

The kits allow implementing detection directly from tumor tissue of biopsied material. Version of kits for circulating tumor DNA detection allows testing of patient’s plasma or serum.