As of January 2018, Biocept’s liquid biopsy technologies are protected by 22 issued patents in the US, EU, Australia, China, Japan, South Korea, as well as other countries. This includes worldwide patent protection on our highly sensitive methods for detecting cancer biomarkers in circulating tumor DNA (ctDNA) and on circulating tumor cells (CTCs).
The Biocept CTC microfluidic channel is unique compared to other cell capture devices in that it uses a unique irregular arrangement of multiple sized posts that are designed to disrupt internal stream-lines for superior cell capture. Additionally, the interior of the microchannel is chemically derivatized to enable the capture of CTCs tagged with cancer specific antibodies. Furthermore, the microfluidic channel is clear glass on one side. This permits direct microscopic examination of captured cells using a combination of immunocytochemical and cytogenetic staining methods used directly within the microfluidic channel.
In addition to the microfluidic channel, Biocept has issued and pending patents world-wide on the use of cocktails of antibodies for the capture and enrichment of cells of interest. This differentiates Biocept from similar companies and allows Biocept to capture a broader array of CTCs. The Biocept antibody capture cocktail, includes antibodies to a number of tumor-associated antigens from cancer cells of both epithelial and mesenchymal phenotype, as well as cancer stem cells. In addition to the sets of specific antigens targeted by the antibody cocktail, this intellectual property also covers the binding of the antibodies to the target CTCs in solution, which we have shown greatly improves the capture efficiency because of superior binding kinetics and the lack of spatial constraints imposed by attachment of the antibodies to a solid surface. While Biocept’s use of this intellectual property is directed primarily to the capture and detection of CTCs, it is also applicable to, and covers, other rare cells and targets of interest such as circulating fetal cells.
Furthermore, our blood collection tube, which contains reagents designed to prevent clumping of blood cells and CTCs that could clog the microfluidic channels and disrupt our assays, are the subject of an issued U.S. Patent. These reagents also provide stability to the sample for shipping and transport, enabling blood samples to be shipped at ambient temperature from anywhere in the world to our laboratory in San Diego, California. We have validated the transport of CTCs at room temperature for any period of time up to 96 hours after collection. When used to transport blood for ctDNA analysis, our proprietary blood collection tubes are validated to preserve specimens for up to 8 days.
Lastly, our patented Target-Selector™ Assays for ctDNA use real-time PCR, Sanger sequencing and next generation sequencing (NGS). The patent encompasses Biocept’s proprietary “switch-blocker” technology, which enriches patient specimens for oncogene mutations of interest, resulting in ultra-high sensitivity and specificity for the detection of cancer-associated mutations. The switch blocker technology is designed to improve detection rates for these oncogenes, allowing physicians to make informed decisions for the selection of therapy and monitoring of treatment response over time for patients with cancer.
Our intellectual property enables Biocept to develop and commercialize its technologies and testing services in a highly differentiated and sustainable manner. The development effort around our intellectual property aims to increase the adoption of blood-based liquid biopsies to test for biomarkers associated with cancer, and to help inform physicians when making treatment decisions for their patients.
Through our CLIA-certified and CAP-accredited clinical laboratory, we provide diagnostic testing and clinical services that utilize our proprietary technology and trade secrets. In particular, we maintain trade secrets with respect to specimen accessioning, sample preparation, and certain aspects of cytogenetic analysis. All of our trade secrets are kept in confidence and we take steps to ensure that our confidential information is not disseminated, including the use of non-disclosure agreements and confidentiality agreements.