Published Case Study Demonstrates the Clinical Utility of Biocept's Liquid Biopsy Test for ALK Rearrangements

SAN DIEGO, April 27, 2018 /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 case report demonstrating the clinical utility of its Target Selector™ ALK gene rearrangement test. The circulating tumor cell (CTC)-based assay detected the ALK gene translocation in a patient diagnosed with non-small cell lung cancer who subsequently received sequential ALK inhibitor therapies and exhibited excellent clinical response to treatment. The article, "Detecting an ALK Rearrangement via Liquid Biopsy Enabled a Targeted Therapy-Based Approach for Treating a Patient with Advanced NSCLC," was published in the Spring 2018 issue of the journal Oncology & Hematology Review.

"Identifying clinically actionable biomarkers is critical for selecting appropriate therapy aimed at improving outcomes for patients with cancer," said Alejandro R. Calvo, MD, FACP, Associate Professor of Medicine, Loma Linda University School of Medicine - KMC Campus, and Medical Oncologist at Kettering Cancer Center in Southwest Ohio. "In this case study, tissue biopsy proved insufficient for providing this information. Biocept's assay, using a blood sample, identified rearrangements of the ALK gene, which enabled the use of targeted therapy and extended this patient's life."

"We believe that demonstrating clinical utility in clinical settings is important for enhancing further adoption of our Target Selector™ assays," said Biocept's President and CEO Michael Nall. "This peer-reviewed article is the first of several clinical case studies that we expect to be published this year as we continue to expand the body of evidence supporting the use of our industry-leading liquid biopsy platform."

About Oncology & Hematology Review

Oncology & Hematology Review is a peer-reviewed, open-access, bi-annual journal comprised of review articles, case reports, practice guides and theoretical discussions. Published each Spring and Fall, the journal aims to help time-pressured physicians to stay abreast of key advances and opinions in oncology practice.

About Biocept's Target Selector™ ALK test

ALK gene rearrangements are found in 2-7% of non-small cell lung cancer (NSCLC) cases, and detection is used to qualify patients for possible therapeutic intervention. Detection of an ALK fusion is used to determine the likelihood of response to crizotinib (Xalkori®) or ceritinib (Zykadia®), two commercially available tyrosine kinase inhibitors. Additionally, alectinib (Alecensa®) and brigatinib (Alunbrig®) are approved for patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. Biocept's Target Selector™ methodology identifies ALK gene translocations in circulating tumor cells (CTCs) by fluorescence in situ hybridization (FISH) with the Vysis ALK Break Apart FISH Probe Kit from Abbott Laboratories (Abbott Park, Illinois, USA); this FISH kit is used routinely by major reference laboratories for the qualitative detection of ALK gene rearrangements in formalin-fixed paraffin-embedded (FFPE) tissue. Biocept's Target Selector™ liquid biopsy platform has the ability to identify ALK gene translocations in patients using a simple blood sample.

For more information on Biocept's ALK test or to order a test from Biocept please go to www.Biocept.com or click on the following link: https://biocept.com/technology/biomarker-index/#alk

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 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 plasma (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 further adoption of our Target Selector assays, and whether additional clinical case studies will be published this year 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.

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