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CIRCULOGENE Announces Issuance of U.S. Patent for Method of Preparing Cell-Free Nucleic Acid Molecules by In Situ Amplification

Issued patent recognizes CIRCULOGENE’s novel method of enriching cfDNA without DNA isolation, extraction or purification, enabling “in situ” genetic manipulation of biofluid samples.

BIRMINGHAM, Ala. – 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.

Transforming precision medicine through the rapid delivery of actionable results, CIRCULOGENE provides comprehensive biomarker testing for a broad range of cancers, allowing physicians to match patient results with specific therapies (or clinical trials) in just one week. The company has developed proprietary next-generation sequencing and qPCR methods that provide a full genomic load analysis, enabling greater data accuracy to help clinicians select targeted therapies, monitor efficacy and assess recurrence for cancer patients. Applying proprietary liquid biopsy innovation for cfDNA and cfRNA, including PD-L1 and MSI detection, CIRCULOGENE can detect circulating germline and somatic mutations and RNA fusions from a single tube of blood, enabling physicians to tailor targeted therapy and immunotherapy without delay.

CIRCULOGENE is a Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) certified laboratory and a Verified Vendor for the federal System for Award Management. For more information, visit our website, connect with us on LinkedIn, Facebook and Twitter, or email us at or call 855-614-7083. Clinicians interested in ordering tests may visit the Contact page on CIRCULOGENE’s website.

Company Contact
Scott Rezek

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