On November 9, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the publication of a study showing that the addition of Switch-Blocker technology to common PCR-based liquid biopsy assays significantly increased sensitivity in detecting rare cancer mutations (Press release, Biocept, NOV 9, 2021, View Source [SID1234594947]). The abstract was published in the November 2021 issue of the Journal of Molecular Diagnostics.
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Biocept’s proprietary Switch-Blocker technology enriches oncogenic mutations of interest while suppressing wild-type (normal) DNA, resulting in ultra-high sensitivity, specificity and accuracy. In this study, Switch-Blockers were combined with conventional real-time PCR and droplet digital PCR (ddPCR) assays.
"Our quantitative Switch-Blocker technology demonstrates an unprecedented ability to find and distinguish extremely rare genetic events—even in blood that contains mostly DNA from normal white blood cells," said Michael Dugan, Chief Medical Officer and Medical Director of Biocept. "This can greatly enhance the clinical sensitivity of our cell-free tumor DNA assays and has broad application in the continued development of highly sensitive and quantitative molecular diagnostic assays used to evaluate cerebrospinal fluid or blood from patients with cancer. Switch-Blocker-based assays can help detect cancer biomarkers that otherwise might be missed, improving treatment selection. They can also be used to evaluate treatment-related changes, find minimal residual disease or identify early disease recurrence."
Results showed that the addition of Switch-Blockers increased the sensitivity of allele-specific primer assays by more than 200 times, from about 1% minor allele frequency (MAF) to better than 0.01%. The sensitivity of multiplex competitive allele-specific TaqMan assays, commonly used with PCR amplification, were increased greater than 1,000 times, from about 10% MAF to 0.01% or better. The ability to significantly increase the sensitivity of conventional mutation assays using Switch-Blocker technology is critical for helping to find rare genetic events in a wide range of applications, including solid tumor cancers, where a majority of biomarkers in blood occur at less than 1% MAF.
The abstract (#TT33), titled "The Use of Switch-Blocker Probes for the Ultra-High Sensitivity of Detection of Rare Genetic Events Using Conventional Real-Time and Droplet Digital PCR Assays," can be accessed here.
About Switch-Blocker Technology
Biocept’s proprietary Switch-Blocker platform is the basis for the company’s Target Selector assays and can be used with tissue, blood and cerebrospinal fluid (CSF) samples. The technology enables industry-leading sensitivity for the detection of mutations/variants from circulating tumor DNA (ctDNA). It has been validated to 0.05% minor allele frequency in blood, which provides significant advantages for identifying actionable cancer biomarkers and assessing therapeutic tumor response. Switch-Blockers enhance the performance and specificity of the PCR method, the most widely used amplification approach for clinical diagnostic applications and can be customized to aid in biopharmaceutical research for the development of targeted therapies for cancer. Switch-Blocker technology also has been validated and found to be highly sensitive, quantitative and reproducible in detecting the presence of the SARS-CoV-2 virus that causes COVID-19 infections.