Biocept Reports Revenue-producing Sample Volume During 2015 Up by 30%+ Each Consecutive Quarter to 1,800+ for the Year

Biocept, Inc. BIOC, a molecular diagnostics company commercializing and developing blood-based biomarkers to improve the detection and treatment of cancer, announces that President and CEO Michael W. Nall has issued the following letter to stockholders: To Our Stockholders and Friends: This year is off to a solid start and we anticipate it to be highly productive as we build on our position as a commercial leader in the fast-developing field of liquid biopsy. Key to success in this emerging industry is test adoption by the medical community, and I'm proud to report that our revenue-producing sample volume exceeded 1,800 for 2015 with each quarter showing sequential growth of more than 30%. I'm excited to share some of the initiatives we have planned for 2016 as we seek to grow our customer base and advance our business strategy with the goal of driving test volume. These include: expanding our test menu with new biomarkers, including the anticipated introduction of a test with direct relevance to many of the new cancer immunotherapies in clinical development; initiating new clinical validation and utility studies, many of which we believe will be in collaboration with well-recognized, leading oncology institutions; establishing a Clinical Advisory Board with key opinion leaders to guide us in expanding our physician customer base; developing additional contracts with health plans to support reimbursement of our tests; and partnering with pharmaceutical companies to assist them in developing therapies, which could provide us with future opportunities to develop assays, or companion diagnostics, that help qualify patients for emerging targeted therapies in early-stage clinical trials. We look forward to providing some detail around our initiatives during our year-end investment community conference call on March 9 and subsequently reporting on our progress throughout the year. The field of liquid biopsy is a multifaceted one and many of you have asked about where Biocept fits. We focus on two segments: the profiling and the monitoring of specific biomarkers in the blood of patients who have been diagnosed with cancer. We currently have commercialized assays based on our patented and proprietary technology for lung, breast, gastric and colorectal cancers, melanoma and, most recently, prostate cancer – all of which have been validated by our onsite CLIA-certified, CAP-accredited laboratory. Our tests provide physicians with important information in making treatment decisions at the time of diagnosis, at disease recurrence and during treatment. These are significant markets with one industry report projecting worldwide sales from liquid biopsy profiling at $7 billion and monitoring at $5 billion by 2020.* An obstacle to developing liquid biopsy tests for cancer is achieving sufficient sensitivity to detect very small amounts of tumor material in bodily fluids. We chose to base our tests on blood because a higher concentration of tumor cells and cancer DNA fragments are found in blood for most solid tumor cancers compared with other fluids, including urine. I'm delighted to report that our tests are showing high specificity (i.e., true negative readings) and sensitivities (i.e., true positive readings) with strong correlations with tissue biopsies. In fact, we recently demonstrated a 93% correlation with tissue biopsies in patients with lung cancer, with that data presented both at the Association for Molecular Pathology meeting in November and just last week at the UCSD Moores Cancer Center Translational Oncology Symposium. We also believe that no single approach can produce the best results for a variety of biomarkers. To that end, we offer several methods of detecting tumor cells through our highly versatile, patented platform utilizing both circulating tumor cells (CTCs) from blood and circulating tumor DNA (ctDNA) from plasma. Importantly, the number of physicians using our tests is increasing. Physicians make decisions and change behavior based on scientific evidence. The uptake in our test volume reflects our ability to accumulate clinical evidence from collaborations with highly reputable institutions that validate our approach. The past year has not been without its challenges. Notable among these has been revenue collection for tests we have performed. We attribute our collection difficulties mainly to new and changed medical billing codes that caused confusion among payers, as well as our need to improve billing processes and procedures. We have been highly focused on resolving these issues and we believe that we are making good progress that we expect will improve timely collections and generate more revenues per test. We also are developing relationships with medical plans to support reimbursement. As a result, the number of patients with access to our liquid biopsy assays through their healthcare insurance plans has now reached approximately 140 million. We are excited to build on our momentum in 2015 and to deliver on the value-creating goals planned for this year. On behalf of my colleagues, our Board and our advisors, thank you for your continued support of Biocept. Sincerely, Michael W. Nall President and Chief Executive Officer
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