Company’s ultra-sensitive and quantitative assays support efforts to develop targeted therapies for cancers driven by a variety of genetic mutations

Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, 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. 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.

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.

About Biocept

Biocept, Inc., develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information to aid in the diagnosis, treatment and monitoring of patients with cancer. In addition to its broad portfolio of blood-based liquid biopsy tests, the company has developed the CNSide™ cerebrospinal fluid assay, designed to diagnose cancer that has metastasized to the central nervous system. Biocept also is leveraging its molecular diagnostic capabilities to offer nationwide RT-PCR-based COVID-19 testing and services to support public health efforts during this unprecedented pandemic. For more information, visit www.biocept.com. Follow Biocept on Facebook, LinkedIn and Twitter.

Forward-Looking Statements Disclaimer

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” "will," “could,” "designed," and "potential" or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements regarding the ability of Biocept’s patented Switch-Blocker technology to identify selected mutations down to a very small mutant frequency and the potential benefits thereof, Biocept’s ability to quickly and cost-effectively develop and build custom assays with high sensitivity and specificity, the potential of those assays to become companion diagnostics, the ability of CNSide cerebrospinal fluid assay to diagnose cancer that has metastasized to the central nervous system and the ability of Biocept’s molecular diagnostic assays to provide physicians with clinically actionable information to aid in the diagnosis, treatment and monitoring of patients with cancer, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including the risk that supply disruptions may impact our ability to quickly and cost-effectively build custom assays, risks associated with the development and approval of a companion diagnostic test, and the risk that our products and services may not perform as expected. These and other risks are described in greater detail under the "Risk Factors" heading of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as filed with the Securities and Exchange Commission (SEC) on August 16, 2021. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

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