On September 21, 2021 Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that it will present data on its Target Selector assay formats for the ultra-sensitive detection of KRAS mutations using Switch-Blocker technology, which provides advantages for the assessment of therapeutic tumor response and is cost effective for serial monitoring (Press release, Biocept, SEP 21, 2021, View Source [SID1234590080]). Biocept’s presentation is on Sept. 23 at 2:00 p.m. EDT at the Third Annual RAS-Targeted Drug Development Summit, where the company will also host a virtual booth from Sept. 21-23, 2021.
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The Summit brings together academic and biopharmaceutical leaders to share insights and data to advance the successful development of targeted monotherapies and combination strategies for RAS-driven cancers. RAS proteins are frequently mutated in cancers. In particular, KRAS mutations are present in approximately 25% of tumors, making them one of the most common gene mutations linked to cancer. They are drivers of some of the deadliest cancers, including lung, colorectal and pancreatic. As a result, there is significant interest among the biopharmaceutical and medical communities to develop and study new, highly targeted therapies to treat such cancers.
To support these efforts, Biocept offers flexible molecular testing solutions based on advanced technology, including its proprietary Switch-Blocker technology. The company’s Target Selector assays and kits, combined with its Switch-Blocker technology, enables the development of superior assays to detect and characterize genetic alterations in patients with cancer. Switch-Blockers enrich for oncogenic mutations while suppressing wild-type (normal) DNA, resulting in ultra-high sensitivity and specificity.
Biocept’s assays can be used to detect circulating tumor DNA (ctDNA) in tissue, blood and cerebrospinal fluid. For liquid biopsy applications, Switch-Blocker technology offers a 50- to 100-fold increase in mutant allele frequency of detection compared to conventional next-generation sequencing (NGS) and has been validated to 0.02% in blood. The technology offers similar analytical advantages in tissue, with the additional benefit of potentially reducing the Quantity Not Sufficient (QNS) rate because of the assay’s low sample input requirement compared to NGS-based assays.
Biocept offers an expanded KRAS assay to detect a variety of KRAS mutations, as well as assays for a wide range of other mutations that are clinically actionable based on NCCN guidelines. It also can develop custom assays with high sensitivity and specificity based on the unique clinical trial needs of biopharmaceutical companies. These cost-effective assays are significantly less expensive than NGS-based tests, an important consideration for companies conducting clinical drug trials.
"As this emerging area of therapeutic development rapidly grows, more companies are targeting rare and specific mutations with their drug candidates," said Michael Dugan, M.D., Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "Our patented Switch-Blocker technology identifies those mutations down to a very small mutant allele frequency. This capability can help companies more accurately identify patients who meet clinical trial inclusion criteria and better stratify patients, with the potential to positively impact patient selection, trial size and duration, costs and results."
"Biopharmaceutical companies often require molecular assays that are customized to meet the specific needs of their trials," said Michael Nall, President and CEO of Biocept. "Whether they are interested in one or multiple variants, we have the ability to quickly and cost-effectively build assays that are specific to their mutations of interest—which could then become companion diagnostics for their therapeutics. We look forward to working with companies to help ensure the success of their clinical trial programs, while expanding the market for our test offerings."
The presentation, titled "The Ultra-Sensitive Detection of KRAS Mutations Using Switch-Blocker to Aid Therapeutic Decisions and Monitoring," can be accessed here. To learn more about how Switch-Blockers in combination with Biocept’s array of liquid biopsy capabilities can help support both prognostic and predictive clinical trial enrichment, visit the virtual booth here.