Biocept, Inc. (Nasdaq: BIOC) (“Biocept” or the “Company”), a leading provider of molecular diagnostic assays, products and services, announces that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12. The abstracts were presented by Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of California, San Diego. The conference, sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO), was held August 10-12 in San Francisco.

“While patients with leptomeningeal metastasis (LM) have limited treatment options, select patients may benefit from targeted therapies,” said Dr. Kumthekar. “Using CNSide in patients with solid tumors and LM to detect HER2 amplification could provide valuable information in treatment decision making.” Dr. Kumthekar is the principal investigator at Northwestern University of Biocept’s ongoing FORESEE clinical trial, which is evaluating the performance of CNSide in monitoring the response of LM to treatment and assessing the impact of CNSide on treatment decisions made by physicians.

“Patients with leptomeningeal carcinomatosis (LMC) have limited survival and early detection by traditional CSF cytology is poor,” said Dr. Piccioni. “From this study, we concluded that using CNSide was superior in detecting LMC, and its ability for molecular profiling on captured CSF tumor cells (CSF-TCs) could improve earlier detection and treatment outcomes.”

A summary of the abstracts is as follows:

• “The HER2 Flip: HER2 Amplification of Tumor Cells in the Cerebrospinal Fluid (CSF-TCs) of Patients with Leptomeningeal Metastasis having solid tumors; implications for treating the LM tumor with anti-HER2 therapy.”
  
  
  
  Results of this study indicated that HER2 amplification in the CSF can be detected in a substantial fraction of CSF-TCs from patients with LM having breast, upper GI and non-small cell lung cancer, and other solid tumors, and that an increased HER2 positivity in LM may imply HER2 as a driver for developing LM. The results suggest that prospective studies are needed to determine if evaluation of HER2 amplification in the CSF of patients with LM having solid tumors should be routinely considered, as it may offer viable treatment options otherwise not considered.
  
  

• “Circulating tumor cell analysis from the cerebrospinal fluid informs early diagnosis, treatment and prognosis in leptomeningeal carcinomatosis (LMC).”
  
  
  
  This study compared traditional CSF cytology and circulating tumor cell (CTC) analysis using CNSide to evaluate patients for presence of LMC. The results suggested that CTC provided superior sensitivity in detecting LMC compared with traditional cytology, and allowed for earlier detection and consequently earlier treatment. Molecular analysis of CTCs also allowed for identification of therapeutic targets specific to the CSF, which provides more information for treatment decision making and potentially improves survival versus historical controls.

The abstracts from both presentations are available on the Biocept website here.

About Biocept

Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample.

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," "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 release are not strictly historical, including without limitation statements regarding the potential benefits and capabilities of CNSide for use in patients with LM and LMC, 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, including that the results of the FORESEE clinical trial may not support the inclusion of CNSide in clinical care guidelines; risks related to our need for additional capital and the risk that our products and services may not perform as expected. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission (SEC), including under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. 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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