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May 29, 2020

Data Affirming Biocept's Target Selector™ Platform Identifies Cancer Mutations in Cerebrospinal Fluid Presented at ASCO 2020 Virtual Scientific Program

Target Selector™ platform shown to be potentially more sensitive than standard-of-care cytology in detecting mutations of brain metastases in cerebrospinal fluid

SAN DIEGO, May 29, 2020 /PRNewswire/ -- Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients with cancer, announces the presentation of data affirming the ability of its Target Selector™ platform to identify potentially actionable mutations in the cerebrospinal fluid of patients whose cancer has metastasized to the central nervous system.  The data were presented today by Kevin Kalinsky, MD, MS, associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, an oncologist at New York-Presbyterian/Columbia University Irving Medical Center, and the study's principal investigator, in a poster at the American Society for Clinical Oncology (ASCO) 2020 Virtual Scientific Program.  The abstract is available here.

The presence of tumor cells in cerebrospinal fluid may be an indicator of brain metastases, which occur when cancer has spread to the central nervous system.  Biocept's Target Selector™ assays can detect circulating tumor cells (CTCs) and circulating DNA (ctDNA) and identify cancer associated biomarkers in cerebrospinal fluid.  The Company can also identify biomarkers with testing CTCs and ctDNA in the blood of patients diagnosed with cancer.  Identifying biomarkers is necessary for physicians in selecting targeted therapies.  Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases during the course of treatment.  In January 2020, Biocept announced the commercial availability of its Target Selector™ cerebrospinal fluid assays for the rapid identification of molecular alterations in brain metastases in patients with primary breast or lung cancer.

The poster presentation today reported higher sensitivity with Target Selector™ in detecting cancer material and identifying leptomeningeal metastases (cancer in the thin layers of tissue that cover and protect the brain and spinal cord) in cerebrospinal fluid compared with cerebrospinal fluid cytology, the standard-of-care technology.

"Cerebrospinal fluid cytology for the detection of leptomeningeal metastases is the standard, but it often results in false negative results, and lacks sensitivity in detecting biomarkers.  These results show Biocept's Target Selector™ is a promising tool to meet an underserved need in providing this critical information," said Dr. Kalinsky.

"We are excited to share these data at ASCO as they support our belief that Target Selector™ has potential applicability for identifying actionable mutations in patients with brain metastases allowing physicians the choice to test cerebrospinal fluid, blood or both when looking for biomarker information in order to choose the most appropriate therapy," said Michael Nall, President and CEO of Biocept.  "We are planning a larger study to further validate the sensitivity of our Target Selector™ technology compared with cerebrospinal fluid cytology with the goal of making our platform the standard of care for leptomeningeal metastases testing.  

"We'd like to thank Dr. Kalinsky for his continued leadership of this study and others at Biocept who help further validate the use of our technology for the benefit of patients with devastating cancer metastases," he added.

Dr. Kalinsky reports no related financial or conflicts of interest with this study.

About Biocept's Cerebrospinal Fluid Testing
A medical procedure known as a spinal tap or lumbar puncture is typically performed to collect cerebrospinal fluid when cancer patients present with central nervous system symptoms, for example confusion or dementia.  More than 200,000 of these procedures are performed annually in the U.S.  Biocept's Target Selector™ testing provides an alternative and potentially more accurate means of detecting biomarkers from CTCs or ctDNA  of patients with cancer that has metastasized to the central nervous system compared with cerebrospinal fluid cytology.  For more information about Biocept's Target Selector™ testing, please contact Biocept Customer Services at 888-332-7729.

About Biocept
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement
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 as to our ability to improve the outcomes of patients diagnosed with cancer, the promise of Biocept's Target Selector™ as a tool to meet an underserved need, Target Selector™ being the best option for identifying actionable mutations in patients with brain metastases, plans for a larger study to further validate the sensitivity of Biocept's Target Selector™ technology compared with cerebrospinal fluid cytology, our ability to make Biocept's platform the standard of care for leptomeningeal metastases testing, and our ability to provide physicians with clinically actionable information for treating and monitoring patients diagnosed 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 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 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.

Investor Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
310-691-7100                                    

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SOURCE Biocept, Inc.