Biocept (BIOC) is an early stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or “liquid biopsy.” its current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic mutations that may qualify a subset of cancer patients for targeted therapy. Often, traditional methodologies such as tissue biopsies are insufficient or unavailable to provide the molecular subtype information necessary for clinical decisions. Biocept assays have the potential to provide more contemporaneous information on the characteristics of a patient’s disease compared with traditional methodologies such as tissue biopsy and radiographic imaging.

Biocept current assays and planned future assays focus on key solid tumor indications utilizing its Target-Selectors liquid biopsy technology platform for the biomarker analysis of CTCs and ctDNA from a standard blood sample. Biocept patented Target-Selector CTC offering is based on an internally developed microfluidics-based cell capture and analysis platform, with enabling features that change how CTC testing is used by clinicians. Biocept patent pending Target-Selector ctDNA technology enables mutation detection with enhanced sensitivity and specificity, and is applicable to nucleic acid from ctDNA or other sample types, such as CTCs, bone marrow, or cerebrospinal fluid. Biocept Target-Selector platforms provide both biomarker detection as well as monitoring capabilities, and require only a patient blood sample. Biocept believe that its Target-Selector platform technology has the potential to be developed and commercialized as in vitro diagnostic (IVD) test kits, and the company is currently pursuing this option.

Biocept corporate headquarters facility located in San Diego, California, it operate a clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and accredited by the College of American Pathologists, or CAP. Biocept also performed all research and development that led to its current assays, and the company also intend to perform all research and development for its planned assays, at this facility. In addition, the company manufacture its microfluidic channels, related equipment and certain reagents. The assays the company offer and intend to offer are classified as laboratory developed tests, or LDTs, under CLIA regulations. CLIA certification is required before any clinical laboratory, including own, may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of health. In addition, the company also participate in and have received CAP accreditation, which includes rigorous bi-annual laboratory inspections and an adherence to specific quality standards.

Biocept has commercialized its Target-Selector assays for a number of solid tumor indications such as: breast cancer, non-small cell lung cancer, or NSCLC, small cell lung cancer, or SCLC, gastric cancer, colorectal cancer, prostate cancer, and melanoma. These assays utilize its dual CTC and ctDNA technology platforms and provide biomarker analysis from a patient’s blood sample. In the case of its breast and gastric cancer offerings, biomarker analysis involves fluorescence in situ hybridization, or FISH, for the detection and quantitation of the human epidermal growth factor receptor 2, or HER2, gene copy number as well as immunocytochemical, or ICC, analysis of estrogen receptor, or ER, protein, as well as androgen receptor, or AR, protein, which are currently commercially available. The company plan to include ICC analysis of progesterone receptor, or PR, proteins as part of the Target-Selector CTC menu in 2017. A patient’s HER2 status provides the physician with information about the appropriateness of therapies such as Herceptin® or Tykerb®. ER and PR status provides the physician with information about the appropriateness of endocrine therapies such as tamoxifen and aromatase inhibitors.

Biocept lung cancer biomarker analysis offering currently includes FISH testing for ALK, ROS1, RET, MET and FGFR1 gene rearrangements, as well as analysis for the T790M, Deletion 19, and L858R mutations of the epidermal growth factor receptor, or EGFR gene, as well as BRAF and KRAS. The L858R mutation of the EGFR gene and Exon 19 deletions as activators of EGFR kinase activity are associated with the use of the drugs Tarceva®, Gilotrif® and Iressa®. For lung cancer, the company also offer a resistance profile assay consisting of the biomarkers MET, HER2 (both of which the company perform using its technology for CTCs), KRAS, and T790M (both of which are performed using ctDNA in plasma). These assays can be used by physicians to identify the mechanism causing disease progression for patients with NSCLC who are being treated with tyrosine kinase inhibitor, or TKI, therapy and therefore may qualify patients for inclusion in a clinical trial. In November 2015, Tagrisso® was approved by the U.S. Food and Drug Administration, providing another biomarker-based therapy for the treatment of patients with EGFR related lung cancer. Tagrisso® is indicated for the treatment of patients with metastatic disease, who have progressed on or after EGFR TKI therapy, and who have acquired a T790M resistance mutation.

Fibroblast growth receptor 1, or FGFR1, amplification is offered using its CTC technology. FGFR1 is present in several tumor types, including both NSCLC and SCLC and has been shown to be a prognostic indicator of progression. FGFR1 is also a key target for several drugs undergoing clinical development. Mutations of the BRAF gene are associated with Zelboraf® and Tafinlar® treatment, as these therapies are both approved for the treatment of patients with melanoma and are in clinical trials for lung cancer. Biocept offer testing for BRAF on blood using its ctDNA offering.

Biocept analytically validated PD-L1 testing utilizing its CTC technology in 2016. PD-L1 is a biomarker that is informative for immuno-oncology therapies currently marketed for lung cancer and melanoma, as well as therapies in development for multiple tumor types. Biocept collaborated with David Rimm, M.D., Ph.D., a pathologist at Yale Medical School, on the analytical development of this assay. Biocept plan to release additional biomarker assays, such as those that test for ESR1 and NRAS, using blood samples to its current menu of biomarker assays. In addition, the company plan to complete the development and offer multiplexed biomarker tests, which will allow the detection and quantitative monitoring of multiple biomarkers in a single assay.

Biocept continue to execute on its strategies intended to expand its business globally, as well as engaging with pharmaceutical companies on clinical trials and assay development. The company has distribution agreements in place in Mexico with Quest Diagnostics to support testing for a large pharmaceutical company partner, as well as an agreement with Progenetics to market its assays in Israel for clinical testing. In addition, the company has distribution agreements in place in Turkey, the Czech Republic, the Philippines, Lebanon, Columbia and Canada.

During 2016, Biocept announced three pharmaceutical collaborations. The first agreement is to provide testing for a clinical trial that includes patients who have leptomeningeal disease or metastatic lung cancer in the brain. In this exploratory trial, the company is testing both cerebral spinal fluid and blood for molecular alterations that could be impacted by treatment. The second agreement is a milestone-based assay development project focused on hepatocellular carcinoma, or liver cancer, whereby the company intend to develop assays utilizing both its CTC and ctDNA technologies for clinical trials. The third collaboration involves a study presented at the European Society for Medical Oncology, or ESMO, Annual Congress in October 2016, whereby collaborators from a large pharmaceutical company, and academic investigators, demonstrated a high concordance between its Target-Selector liquid biopsy and tissue biopsy. Subsequent to this study, the company has earned business in both Mexico and Columbia for EGFR testing in blood to qualify patients for a pharmaceutical company’s targeted therapy.

In January 2017, Biocept announced that the company had secured an in-network provider agreement with Blue Cross Blue Shield of Texas, the largest provider of health benefits in Texas.

In March 2017, Biocept announced a collaboration with Catalyst Pharmaceuticals for the provision of its Target-Selector platform to screen patients diagnosed with Lambert Eaton Myasthenic Syndrome, or LEMS, for early onset or recurrence of SCLC. Under this agreement, its liquid biopsy tests will be offered by Catalyst Pharmaceuticals at no cost to all patients enrolled in its ongoing Phase III clinical trial designed to demonstrate the safety and efficacy of Firdapse® (amifampridine phsophate) for the treatment of LEMS. Catalyst Pharmaceuticals will pay us for tests ordered and utilized as part of the agreement. Patients in the Phase III clinical trial will also have access to its liquid biopsy testing in the long-term extension study phase of the trial allowing for testing every six months for up to two years to monitor for early signals of SCLC.

In April 2017, Biocept announced its entry into a Preferred Provider Collaboration and Services Agreement with Oregon Health & Sciences University on behalf of the OHSU Knight Cancer Institute, or collectively OHSU. The multiphase agreement grants OHSU the rights to commercially offer its Target-Selector liquid biopsy testing services exclusively throughout the state of Oregon. Additionally, the company and OHSU plan to engage in technology transfer, whereby OHSU will have the ability to use Target-Selector assays in-house, and act as a secondary laboratory for its research and testing activities. Biocept and OHSU also plan to co-develop additional liquid biopsy assay technologies and platform capabilities including highly sensitive, multiplexed assay panels for molecular biomarker detection and assessment. Additional R&D and commercial pilot projects are anticipated under the agreement.

In May 2017, Biocept announced jointly with the Addario Lung Cancer Medical Institute, or ALCMI, entry into a clinical collaboration and initiation of the ALCMI-009 liquid biopsy clinical trial. This large-scale trial was developed, and will be conducted, by ALCMI and its consortium of leading U.S. and international oncology centers. The prospective, multi-center study, which plans to enroll 400 patients, will utilize its Target-Selector testing platform and services to detect and assess cancer biomarkers found in both CTCs and ctDNA from the blood of patients with lung cancer.

Revenue generating efforts are focused in three areas:

• providing clinical testing that oncologists use in order to determine the best treatment plan for their patients;
• providing clinical trial, research and development services to biopharmaceutial companies developing drug candidates to treat cancer; and
• licensing its proprietary testing and/or technologies to partners in the United States and abroad.