Aegea Biotechnologies, a biotechnology company, announces the issuance of a collection of patents including US Patent 9,428,747 entitled methods for amplification of nucleic acids utilising hairpin loop or duplex primers, the issuance of US patent 9,738,925 entitled methods for immobilising target nucleic acids utilising combinatorial capture probes, and the issuance of US patent 9,834,817 as well as Australian patent 2012250516 and Chinese patent zl201280032293.0, all entitled methods for detecting nucleic acid sequence variants. these patents collectively enable the capture, amplification and precise detection of nucleic acid sequences.

US Patent 9,834,817 and its Australian and Chinese counterparts encompass the “switch-blocker” technology and are jointly assigned to Aegea and Biocept, Inc. This switch-blocker technology is core to Biocept’s Target Selector assays for circulating tumor DNA (ctDNA) analysis, using real-time PCR, Sanger sequencing and next generation sequencing (NGS). When used with ctDNA, the switch-blocker technology has ultra-high sensitivity and specificity for the detection of rare mutations associated with cancer and can also be used to enrich patient specimens for oncogene mutations of interest.

“We are very pleased by the issuance of this initial series of Aegea patents and expect many more patent allowances both in the US and worldwide,” said Lyle Arnold, Ph.D., Aegea’s President and Founder. “Our goal is to leverage Aegea technology to advance biotechnology, particularly in the area of clinical diagnostics, and improve the lives of patients suffering from a wide variety of diseases, including genetic and infectious disease, as well as patients with cancer.”

Michael Dunn, a board member at Aegea and its acting business development head, added, "We are quite excited about the issuance of these patents, especially the 9,834,817 patent and its foreign counterparts, covering the switch-blocker technology. The fact that this technology has already been commercialised by Biocept, Inc. through its CLIA testing laboratory in the form of laboratory developed tests (LDTs) as Target Selector assays is indicative of the advanced stage of the technology, and its broad potential in many different applications. It is relatively straightforward to design new switch-blocker assays for mutations and rare genetic variants of interest.”

Mr. Dunn continued, “Importantly, Aegea and Biocept have divided commercial rights to the switch-blocker technology, but not the capture and amplification intellectual property, which are solely owned by Aegea. Biocept has rights to commercialise the switch blocker technology in its LDTs and in in vitro diagnostic (IVD) kits in oncology for certain specific sample types (blood, tissue, bone marrow and CSF). Aegea has all other commercial rights, including rights for research applications, such as research use only (RUO) reagents and kits in all areas including oncology, as well as LDTs and IVDs in all areas outside of oncology and all sample types within oncology other than blood, tissue, bone marrow, and CSF. Aegea plans to build a business around products employing the switch blocker technology and its other technologies, and looks forward to discussions with groups that have an interest in applying AEGEA’s intellectual property to their challenges and opportunities.”

US Patent No. 9,834,817 and its Australian and Chinese equivalents cover the switch-blocker technology, which is applicable to a broad range of molecular genomic platforms, including real-time polymerase chain reaction (PCR), digital PCR, mass-spec, arrays, capillary detection systems, Sanger sequencing, and Next Generation Sequencing (NGS). This technology allows robust amplification of genetic material harboring mutations or alterations while essentially completely blocking amplification of normal (wild-type) genetic material. This method greatly enriches the number of desired target sequences vs background, increasing the detection sensitivity of mutations in low abundance. At the same time, the cost of running assays to achieve high sensitivity, like NGS assays, can be reduced by approximately 100 to 1,000-fold, since the expense of sequencing large amounts of uninformative normal nucleic acid is eliminated.

Aegea Biotechnologies, Inc., located in San Diego, California, is a biotechnology company focusing on the development and commercialisation of next generation nucleic acid technologies. A primary focus for the company is nucleic acid technology innovations that embrace molecular diagnostic assays, qPCR technologies, and sequencing methods including both Sanger and NGS.