Ability to serially monitor treatment response, identify key biomarkers and customize assay aids clinical research efforts to improve treatment for metastatic cancers involving brain and spinal cord

Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, highlighted the ability of its CNSide™ cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting. The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego.

During the presentation, Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director, discussed the growing interest in improving the diagnosis and treatment of leptomeningeal disease (LMD), a devastating complication in which metastatic cancer spreads to the membrane surrounding the brain and spinal cord. Newer targeted therapies can often reduce or resolve debilitating symptoms of LMD and extend life expectancy. However, the current standards of care, CSF cytology and radiological imaging, have limited sensitivity for detecting central nervous system metastasis, and do not identify molecular treatment targets or quantify tumor cell counts.

“A key to precision medicine is identifying molecular targets for therapy,” Dr. Dugan said. “Relying on the primary tumor is not sufficient because biomarker status often differs between the primary and metastatic tumors. With CNSide, we have the first commercially available method to measure biomarker status in real-time during therapy and quantify changes in tumor cell counts to really understand how patients are responding to therapy—as opposed to waiting months for radiologic changes or another surgical biopsy.”

“Companies developing novel therapies for metastatic brain cancers face significant challenges in determining treatment response with traditional methods,” said Samuel D. Riccitelli, Biocept’s Chairman, and Interim President and CEO. “We believe that serial quantitative monitoring with our CNSide assay can have a tremendous impact on the success of many therapeutic clinical trials, and we are pleased to support these important research efforts aimed at providing new treatments for patients with limited time and options.”

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. The assay answers three key questions that may help inform treatment decisions: Is there tumor? Is there a target for treatment? Is there a trend to treatment response? Because genetic changes can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic breast, lung, and other cancers, to help guide therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to more effectively monitor the response to therapy than other current methods.

A recording of the presentation, titled “A Novel CSF Assay to Help Diagnose, Manage, and Follow Response to Therapy in Patients with Leptomeningeal Metastasis,” will be available on the Biocept website after the conference concludes.

About Biocept

Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers. In addition to its broad portfolio of blood-based liquid biopsy assays, Biocept has developed the CNSide™ cerebrospinal fluid assay that detects cancer that has metastasized to the central nervous system. Biocept’s patented Target Selector™ technology captures and quantitatively analyzes cerebrospinal fluid tumor cells for tumor-associated molecular markers, using technology first developed for use in blood. Biocept also is leveraging its molecular diagnostic capabilities to offer nationwide COVID-19 RT-PCR testing 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 news 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 be correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend" or "project," or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements as to the ability of CNSide to impact life expectancy and quality of life, our ability to establish CNSide as the new standard of care for the diagnosis of patients with suspected cancer metastasis to the CNS, our ability to expand our CSF testing menu for additional tumor types and biomarkers in the future, and our ability to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers, 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 risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news 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 at http://www.sec.gov/.

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