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Feb 5, 2019

Published Case Series Indicates the Ability of Biocept's Liquid Biopsy Testing to Identify Actionable Biomarkers When Tissue Biopsy Is Unsuccessful

Peer-reviewed article in journal, Clinics in Oncology, further supports the clinical utility of Biocept's Target Selector™ platform to aid physicians in the selection of targeted therapy for patients with lung cancer

SAN DIEGO, Feb. 5, 2019 /PRNewswire/ -- Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the publication of a peer-reviewed article featuring a case series of three patients indicating the clinical utility of Biocept's Target Selector™ circulating tumor DNA (ctDNA) testing in the management of patients with advanced non-small cell lung cancer (NSCLC). In each of the three patient cases, Biocept's liquid biopsy testing detected activating EGFR mutations where tissue biopsy was inadequate, and targeted EGFR-directed therapy was subsequently administered. One patient had a complete response to therapy for approximately two years, and two of the three patients received third-generation tyrosine kinase inhibitor (TKI) treatment with osimertinib (Tagrisso®) after their disease had progressed and the resistance mutation, EGFR T790M, was identified in their blood.

Biocept Logo (PRNewsFoto/Biocept, Inc.)

The article, "Demonstrated Clinical Utility of Target Selector™ ctDNA testing: Liquid Biopsy EGFR mutation Detection Enabled Targeted Therapy Selection for Three Advanced NSCLC patients," was published in the January 2019 issue of the medical journal Clinics in Oncology.

"Biocept's highly sensitive liquid biopsy testing was able to identify positive EGFR activating mutation biomarker status in all three patients at diagnosis when tissue biopsy was insufficient. Furthermore, emergence of the EGFR T790M resistance mutation was detected in two of these patients upon disease progression," said Rodrigo Erlich, MD, who treated these patients at Bay Oncology, Easton, Maryland. Dr. Erlich is presently a Medical Oncologist at the Memorial Sloan Kettering Cancer Center, New York, NY. "Liquid biopsy is proving to be a viable alternative method to tissue biopsy for obtaining actionable biomarker information that can enable oncologists to select appropriate targeted therapy and improve treatment outcomes."

"With our first peer-reviewed publication of the new year, we continue to expand the clinical evidence supporting the use of our Target Selector™ platform," said Biocept's President and CEO Michael Nall. "These case reports further demonstrate how liquid biopsy testing can play a critical role in identifying biomarkers to help physicians make informed treatment decisions, particularly when tissue biopsy has failed to do so. We believe that demonstrating clinical utility in real-world settings is important to increase physician adoption of our Target Selector™ assays, and we expect to submit additional case studies to prominent medical journals in 2019."

About Biocept's Target Selector™ Testing for Lung Cancer

Non-small cell lung cancer (NSCLC) is not a single disease, but a collection of cancer types whose pathology is classified by histology (cells) and molecular profiling (genetic and protein biomarkers). The discovery of molecular alterations in genes, such as EGFR, ALK, and ROS1, have improved physicians' ability to manage advanced lung cancer. Identifying these markers is crucial to offering patients the most advanced treatments available. The NCCN, ASCO, and The College of American Pathology (CAP) all provide guidelines regarding which patients should receive molecular profiling, when they should be profiled, and what tests should be ordered. Biocept has developed advanced methods for finding cancer cells and DNA fragments in a blood sample. Biocept's CLIA-certified and CAP-accredited laboratory provides tests that can establish up-to-date clinically actionable biomarker status. Liquid biopsies can often provide the same type of information obtained from a tissue biopsy—but from a non-invasive simple blood test. And because Biocept uses blood, real-time information about a patient's cancer and how they are responding to treatment may be determined.

For more information on Biocept's Lung Cancer test offering or to order a test from Biocept please go to www.Biocept.com or click on the following link: https://biocept.com/lung-cancer/  

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for biomarker analysis for lung, breast, gastric, colorectal and prostate cancers, and melanoma.  The Company uses its proprietary liquid biopsy technology to provide physicians with information to help treat and monitor 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 plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to help 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, our ability to increase physician adoption of our Target Selector assays, and whether additional case studies will be published in the future supporting the use of our liquid biopsy platform, 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:
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Jody Cain


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