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Company Description

Contact Info

5810 Nancy Ridge Drive

Suite 150

San Diego, CA 92121

United States

Phone: 858-320-8200

Fax: 858-320-8225

Biocept, Inc., a cancer diagnostics company, develops and commercializes proprietary circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) tests. The company’s tests provide information to oncologists that enable them to select the appropriate treatment for their patients based on detailed data on the characteristics of tumors. The company’s breast cancer test and its planned future tests utilize its Cell Enrichment and Extraction (CEE) technology for the detection and analysis of CTCs, and its CEE-Selector technology for the detection and analysis of ctDNA, each performed on a standard blood sample. Proprietary Tests and Services The company offers OncoCEE-BR, a breast cancer CTC test that allows physician to characterize the tumor to help define treatment options. The company offers this test to physicians through its Clinical Laboratory Improvement Amendments of 1988 (CLIA) laboratory. The test includes CTC enumeration and determination of human epidermal growth factor receptor 2 (HER2) status by fluorescence in situ hybridization (FISH) on the captured CTCs. Other OncoCEE CTC Tests in Development The company is developing additional OncoCEE CTC tests for cancer types other than breast cancer. These tests include OncoCEE-LU for lung cancer, OncoCEE-GA for gastric cancer, OncoCEE-CRTM for colorectal cancer, OncoCEE-PR for prostate cancer, and OncoCEE-ME for melanoma. OncoCEE-LU: The company’s OncoCEE-LU test would include various components: CTC enumeration, FISH analysis for echinoderm microtubule-associated protein-like 4/anaplastic lymphoma kinase (EML4/ALK) and ROS1 (c-ros oncogene 1, receptor tyrosine kinase), and potentially for ret proto-oncogene. OncoCEE-GA: The company is developing its OncoCEE-GA test for gastric cancer based on the identification of HER2 as a biomarker for this disease. Its OncoCEE-GA test would include CTC enumeration and HER2 analysis of CTCs by FISH. OncoCEE-CR: The company’s plan for its OncoCEE-CR test for colorectal cancer is to offer mutation testing analogous to that performed on lung cancer CTCs, namely detection of key mutations in the epidermal growth factor receptor (EGFR), K-ras and B-raf genes, along with CTC enumeration. OncoCEE-PR: The company’s OncoCEE-PR test for prostate cancer would be based on the analysis of CTCs found in a standard blood sample by FISH for key biomarkers: the androgen receptor, and phosphatase and tensin homolog. The test would also include CTC enumeration, and its CEE-Cap antibody capture cocktail would be modified from that used for breast and lung cancer to include prostate specific membrane antigen. OncoCEE-ME: The company’s OncoCEE-ME melanoma test, performed on a standard blood sample, would provide information on the presence or absence and specific nature of the V600 mutation in the B-raf gene, which indicates whether the B-raf inhibitors Xelboraf or Tafinlar are candidate therapies for the patient. CTC enumeration would also be a component of its test. ctDNA Tests The company plans to introduce ctDNA tests for mutation analysis performed on blood plasma isolated from a standard blood sample using the CEE-Selector technology, based on increasing interest in the research community in this type of analysis. The company plans to launch the first tests, for K-ras, B-raf and EGFR mutations, in conjunction with, or as a complement to, its OncoCEE-LU test. Laboratory Testing From its CLIA laboratory in San Diego, California, the company plans to provide test results from its proprietary CTC and ctDNA tests to oncologists in community hospitals, cancer centers, group practices, and offices. Clinical Trials Services The company, in addition to testing for oncologists and their patients, plans to offer clinical trials testing services to help increase the viability of clinical trials for pharmaceutical and biopharmaceutical companies and clinical research organizations. The company’s clinical trial services would be targeted at developing customizable tests and techniques utilizing its proprietary CTC and ctDNA technologies to provide sensitive, real-time characterization of individual patient’s tum

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