Issued patent recognizes CIRCULOGENE’s novel method of enriching cfDNA without DNA isolation, extraction or purification, enabling “in situ” genetic manipulation of biofluid samples
CIRCULOGENE, an innovative molecular diagnostics company transforming precision medicine through the rapid delivery of actionable results, announced today that the United States Patent and Trademark Office has issued U.S. Patent No. 11,015,213 for its proprietary cell-free nucleic acid (cfNA) preparation methodology. The patent, titled “Method of Preparing Cell Free Nucleic Acid Molecules by In Situ Amplification,” covers methods for the linear in situ amplification (LISA) of cfNA, such as cell-free DNA (cfDNA), in a liquid sample. The patent also describes how this novel methodology overcomes current analysis limitations associated with large sample volume requirements, low yield of cfDNA, differential recovery of different size cfDNA fragments, and lack of reproducibility through direct-on-specimen cfDNA enrichment without a purification step.
CIRCULOGENE’s LISA technology serves as the foundation of the company’s high-throughput liquid biopsy workflow for targeted cancer therapy selection. The proprietary amplification technology involves a seamless isolation-free, wash-free and loss-free process, resulting in improved yield of high quality cfDNA fragments that are ready for next-generation sequencing and qPCR testing.
“Issuance of this patent further validates our innovative approach to molecular diagnostics,” said CIRCULOGENE President and CEO Mike Mullen. “This advanced technology allows us to better serve oncologists and cancer patients through the rapid and comprehensive genomic assessment of solid tumors for therapy selection, response monitoring and disease recurrence.”
“This is a breakthrough invention in the world of liquid biopsy,” said CIRCULOGENE Chief Scientific Officer Chen-Hsiung Yeh, Ph.D. “As therapies targeting tumors with specific gene mutations and gene fusions expand, the accurate and timely detection of associated biomarkers has become essential for physicians to provide the best treatment options for cancer patients.”
Recognition of the invention will help CIRCULOGENE continue to explore its benefits to realize the full potential of cfDNA analysis, with advantages that include:
- More complete characterization of genetic alterations
- Expedited clinical decision making
- Identification of targeted therapies
- Identification of experimental clinical trials for eligible patients in a time- and cost-efficient manner
Broad applications of the LISA technology range from early cancer and infectious disease detection to organ transplantation and tissue-of-origin tracking. CIRCULOGENE’s LISA technology is currently being utilized in a U.S. Department of Defense battlefield trauma research project for the rapid identification and assessment of organ-specific injury biomarkers – including traumatic brain injury.
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