Biocept’s CNSide Assay Identifies Tumor Cells and Actionable Treatment Biomarkers from Cerebrospinal Fluid in Patients with Metastatic Non-Small Cell Lung Cancer

Study to be presented at the Society for Neuro-Oncology Third Annual Conference on Brain Metastases, Aug. 19-20

Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, today announced that new data show the company’s cerebrospinal fluid assay, CNSide™, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy. The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021.

More than 198,000 patients are diagnosed with non-small cell lung cancer (NSCLC) each year. An estimated 3-9% of those patients will develop leptomeningeal carcinomatosis (LMC), a complication in which the cancer spreads to the membranes surrounding the brain and spinal cord. LMC is typically diagnosed through clinical evaluation, imaging and cytology, which have limited sensitivity. When left untreated, the average patient life expectancy is just four to six weeks.

The retrospective study, conducted at the University of Utah Huntsman Cancer Institute, used Biocept’s CNSide assay to detect and analyze tumor cells in the cerebrospinal fluid of 15 unique patients. Of the samples analyzed, CNSide detected tumor cells in 100% of samples with LMC, while cytology detected tumor cells in just 40% of the samples. CNSide also identified actionable biomarkers in tumor cells, which allowed oncologists to make targeted treatment decisions that reduced debilitating symptoms and extended patient lives by more than three years in some cases. The study results suggest that CNSide is more sensitive than cytology, and survival of patients with LMC can be prolonged if an actionable target is identified and treated.

“LMC is a devastating diagnosis for patients and, quite often, hospice is the only recommended course of action,” said Wallace Akerley, M.D., University of Utah Huntsman Cancer Institute, and lead study investigator. “However, we now have targeted therapies that can improve and dramatically extend the lives of patients with LMC who have a treatable mutation. This study shows that using CNSide to interrogate the cerebrospinal fluid for actionable mutations provides the information needed to determine the appropriate treatment for patients with LMC. With the right therapy, we have the ability to restore quality of life and extend life expectancy for many patients.”

“Identifying actionable mutations is critical for treating patients with LMC,” said Michael C. Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. “CNSide has demonstrated the ability to reliably detect and analyze tumor cells in the cerebrospinal fluid that may not be found in blood or tissue samples. The specific molecular targets identified in these tumor cells can help guide a physician's choice of newer, more effective therapies and inform the response to therapy in a way that can really help these patients see an improvement of symptoms and live significantly longer lives."

The study, titled “Beyond Cytology – A Single Institution Experience Using CNSide™ for Diagnosing and Monitoring Treatment Response in Non-Small Cell Lung Cancer Patients with Leptomeningeal Carcinomatosis (LMC),” can be accessed 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," "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 CNSide to identify actionable mutations in lung cancer patients with LMC that allow for targeted treatment decisions that may improve outcomes and extend life expectancy, 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210819005178/en/