Mutations in the BRCA1 and BRCA2 genes are the two most common genetic alterations in the high-penetrance form of hereditary breast and ovarian cancer. BRCA1 and BRCA2 genes produce tumour suppressor proteins, and any changes or mutations in these genes can lead to significantly increased risk of developing breast, ovarian, and prostate cancer. Approximately 55 to 72% of women who inherit a harmful BRCA1 variant and 45 to 69% of women who inherit a harmful BRCA2 variant will develop breast cancer by 70 to 80 years of age. Early and precise detection of these mutations is essential not only for confirming diagnosis but also for identifying at-risk individuals, guiding preventive strategies, facilitating family counselling, and enabling targeted therapy selection.
To meet this critical need, Genes2Me introduces the BRCA-Q Real-Time PCR Kit — an advanced in vitro diagnostic solution designed for the qualitative detection of BRCA1 and BRCA2 mutations in genomic DNA extracted from blood (EDTA) and formalin-fixed paraffin-embedded (FFPE) tissue. The kit detects and differentiates eight genetic polymorphisms associated with breast and ovarian cancer across seven BRCA1 variants and one BRCA2 variant, empowering laboratories with accurate, fast, and reproducible results for cancer risk assessment, diagnosis, and treatment planning.
The BRCA-Q Kit uses a real-time PCR protocol based on amplification of specific target DNA sequences, followed by detection using melting curve analysis. The assay employs fluorescent, allele-specific probes — each designed to selectively bind one of the two alleles of the target gene. Three distinguishably labelled probes carry different reporter dyes: FAM for the wild-type (WT) allele, HEX for the mutant (MT) allele, and Cy5 for the internal control (IC).
Following amplification, melting curve analysis of the amplicon-probe complexes is performed. During melting, changes in fluorescence are continuously monitored by the real-time thermal cycler. When a probe is perfectly complementary to the target DNA, it exhibits a higher melting temperature (Tm), whereas partial complementarity results in a lower Tm. Result interpretation is based on observed melting temperatures, allowing accurate discrimination between wild-type and mutant allelic variants. The Cy5-labelled internal control validates DNA input, reagent integrity, and PCR performance in every run, with a Ct value cut-off of 32 for differentiating valid from invalid results.
BRCA1 and BRCA2 mutation testing is central to hereditary cancer risk assessment and the clinical management of breast, ovarian, and prostate cancers. Comprehensive detection and allelic differentiation of seven BRCA1 mutations and one BRCA2 mutation provides oncologists and genetic counsellors with actionable insights to stratify patient risk, guide preventive care, and tailor targeted therapies. With 99% clinical sensitivity and 99% clinical specificity, and a limit of detection of 1 genome equivalent per 1.0 ng of human DNA per reaction, the BRCA-Q Real-Time PCR Kit enables early identification of mutation carriers and plays a crucial role in reducing cancer mortality and improving patient outcomes.
Detects and discriminates eight clinically significant genetic polymorphisms — seven BRCA1 mutations (185delAG, 4153delA, 5382insC, 3819delGTAAA, 3875delGTCT, 300T>G [Cys61Gly], 2080delA) and one BRCA2 mutation (6174delT) — providing a complete mutation profile for cancer risk assessment and therapy guidance.
Allele-specific probes with three reporter dyes — FAM for wild-type alleles, HEX for mutant alleles, and Cy5 for the internal control — enable simultaneous detection and accurate discrimination of normal and mutant allelic variants in a single reaction.
Post-amplification melting curve analysis enables precise differentiation of wild-type and mutant alleles based on distinct melting temperatures, allowing confident allelic discrimination even in heterozygous samples.
Built-in Cy5-labelled internal control validates DNA input, reagent integrity, and PCR performance in every run; a Ct value cut-off of 32 differentiates valid from invalid results.
Delivers 100% analytical sensitivity and specificity, 99% accuracy, and 99% clinical sensitivity and specificity, with a limit of detection of 1 genome equivalent per 1.0 ng of human DNA per reaction.
Validated on leading real-time PCR platforms including Thermo Fisher QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and Genes2Me RapiCycler 96.
With the BRCA-Q Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection and allelic differentiation of BRCA1 and BRCA2 mutations. By supporting comprehensive profiling across eight high-risk variants through a validated melting curve analysis workflow, the kit helps clinicians and genetic counsellors make informed decisions for cancer risk stratification, preventive care, and targeted therapy selection. Empower your laboratory with the BRCA-Q Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.
When the Ct value of the sample to be tested is outside the reference range and there is a typical S-shaped amplification curve, the test result is positive; When the Ct value of the sample to be tested is within the reference range, or the Ct value is outside the reference range but there is no typical S-shaped amplification curve, the test result is negative.
Channel 1 Slope: -3.392 Intercept: 39.372 Correlation: -0.998 Efficiency 3: 97.1430 Channel 3 Slope: -3.240 Intercept: 38.672 Correlation: -0.999 Efficiency 2: 103.52
| Commercial Name | Old Cat No. | New Cat No. | Pack Size |
|---|---|---|---|
| BRCA-Q Real-Time PCR Kit | G2M802521 | G610043-1 | 50 Tests |
Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.
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