Cangene Corp.

OECD approves application to initiate regulatory acceptance process for ecNGS technology, an improved method for mutagenesis testing. Duplex Sequencing ecNGS mutagenesis assays are poised to set benchmark for safety assessment in diverse sectors including pharmaceuticals, food, chemicals, and cosmetics as well as reduce the use of transgenic animals globally. This milestone underscores the power of TwinStrand's patented Duplex Sequencing technology to advance the field of genetic toxicology, preventing carcinogenic products from entering the market, and ensuring the highest standards of safety in pharmaceutical and consumer products worldwide. SEATTLE, April 24, 2024 /PRNewswire/ -- TwinStrand Biosciences®, the pioneer in Duplex Sequencing technology, which delivers accurate insights to researchers in applications ranging from genetic toxicology to residual cancer detection announces the successful acceptance of the standard project submission form (SPSF) by the Organization for Economic Cooperation and Development (OECD). This significant milestone will accelerate commencement of the global regulatory acceptance process for error-corrected Next Generation Sequencing (ecNGS) for mutagenesis testing. "We are excited about this opportunity for ecNGS to become an approved tool for regulatory genotoxicity testing. By advancing our ability to evaluate mutation frequency and spectrums across any genome, these approaches can provide more precise and informative data for human health," states Connie Chen from The Health and Environmental Sciences Institute's Genetic Toxicology Technical Committee (HESI). TwinStrand DuplexSeq™ mutagenesis assays outperform traditional mutagenicity methods by providing additional mechanistic insights, potentially reducing animal testing while enhancing detection of mutagenic compounds. The primary strength of Duplex Sequencing lies in its precise detection of chemically-induced DNA mutations (approximately 1 in 10 million) with exceptional accuracy. This capability provides valuable insights, enabling the inference of mutational processes directly implicated in human cancers. The company believes this will transform genetic safety by facilitating the identification of problematic compounds during drug development, ultimately saving significant time and costs. "Gaining global approval for Duplex Sequencing to become the standard for mutagenesis testing is a huge achievement for our team," said Ron Andrews, CEO of TwinStrand. "Today's news allows us to initiate our commercial outreach to fully take advantage of the opportunity and to ensure we provide access across different industries. We believe that Duplex Sequencing's versatile applicability, extending beyond specific rodent species and cell types to DNA itself, presents a significant improvement for streamlined Genetic Toxicology studies." About TwinStrand Biosciences TwinStrand Biosciences' Duplex Sequencing is the foundational technology enabling the ability to accurately identify ultra-low frequency genomic variants that are undetectable by conventional NGS methods. The company's highly sensitive and specific, patented Duplex Sequencing technology delivers clearer insights to researchers and clinicians in applications ranging from residual cancer detection to genetic toxicology. This data can inform critical decisions in clinical medicine, public health, and other fields of science on a faster timescale when actions are most impactful. TwinStrand's scientist-leaders have authored more than thirty peer-reviewed articles using Duplex Sequencing technology and have developed a portfolio of more than 150 patents and patent applications. The company has partnered with pharmaceutical companies, academic centers, clinical research networks, molecular diagnostic companies, and federal regulatory agencies to bring high precision genomics to the forefront of their science. For more information visit . Contact TwinStrand Biosciences Matt Edwards [email protected] SOURCE TwinStrand Biosciences

Guardant had previously aimed to counter the suit by petitioning the U.S. Patent and Trademark Office to review the validity of UW's patents, but the PTO's board ultimately sided with TwinStrand in October. The separate jury trial's verdict equates to about 6% of about $1.4 billion of Guardant's revenues. The cancer blood test developer Guardant Health is on the hook to pay $83.4 million following a jury’s verdict this week in a federal patent case lodged by TwinStrand Biosciences and the University of Washington.  The nucleus of the case involves multiple patents on DNA sequencing methods that were developed by TwinStrand’s former CEO, Jesse Salk, M.D., Ph.D., while he was a medical student at the university, alongside his colleagues.  The Seattle-based TwinStrand holds an exclusive license to the technology—which it describes as capable of being 10,000 times more accurate than typical next-generation sequencing, by independently checking both strands of DNA and matching them up to eliminate reading errors—which the company uses to underpin its blood plasma tests for detecting rare and hard-to-spot genetic mutations linked to different cancers. TwinStrand first filed a lawsuit against Guardant in August 2021. In its complaint, the company claimed Guardant’s sequencing technologies and tests had infringed on its patents through its Guardant360 blood and tissue kits. TwinStrand would launch its first commercial DuplexSeq kit in 2020. In the meantime, Guardant had aimed to counter the suit by petitioning the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board—asking for additional reviews of the validity of UW’s patents, and whether they should have been issued in the first place. Guardant had said that redundant readings of DNA and the use of barcoding molecules to catch sequencing errors were commonplace approaches, and used by other companies such as Pacific Biosciences. However, the PTAB’s final decision, issued in early October of this year, found in favor of TwinStrand and the university, and ultimately allowed the patents to stand. A month later, the jury in Delaware federal district court followed suit—finding that Guardant owed $83.4 million in royalty payments, for a figure equal to 6% of about $1.4 billion in Guardant revenues. Guardant has said it plans to appeal not only the jury’s decision, but also the PTAB’s findings and will bring the latter to the federal circuit court of appeals. “We strongly disagree with this decision and will vigorously appeal for its overturn,” Guardant co-founder and co-CEO Helmy Eltoukhy said in a statement regarding the Delaware verdict. “We believe the ruling ignores the strengths and merits of our R&D and intellectual property, which we painstakingly developed for over a decade.”

Federal jury finds Guardant Health, GH (NASDAQ), willfully infringes University of Washington duplex sequencing patents exclusively licensed to TwinStrand Biosciences, Inc. and awards $ 83.4M in damages. Jury finds FDA-approved product Guardant 360® CDx infringes the University of Washington's patents, along with all of Guardant Health's commercial products which analyze cell free DNA obtained from blood draws to detect, screen, and/or characterize cancer. Guardant Health did not challenge the validity of the patents in district court. Previously, on October 10, 2023, the Patent Trial and Appeal Board rejected all of Guardant' Health's invalidity arguments regarding 30 claims of UW's '127 patent. The duplex sequencing technology that is covered by these patents can deliver 10,000x greater accuracy than standard next generation sequencing, allowing for exquisitely sensitive mutation and genetic allele detection to inform critical medical decisions and drug development pipelines. SEATTLE, Nov. 15, 2023 /PRNewswire/ -- TwinStrand Biosciences®, the pioneer in Duplex Sequencing technology, which delivers accurate insights to researchers in applications ranging from residual cancer detection to genetic toxicology, announced a successful jury verdict in the federal patent infringement case it brought with the University of Washington against Guardant Health. The jury found that Guardant Health willfully infringed two of the University of Washington's duplex sequencing patents in the sale of its FDA-approved Guardant 360 CDx product, as well as all of its commercial products in cancer screening, detection, and characterization. The patents at issue were U.S. Patent No. 10,760,127 and U.S. Patent No. 10,287,631, both owned by the University of Washington and exclusively licensed to TwinStrand Biosciences, Inc., which was founded by the inventors of the patents. "We are grateful that the jury has protected the foundational duplex sequencing invention of Dr. Michael Schmitt, Dr. Jesse Salk, and Dr. Lawrence Loeb and the rights of those who own and license it, so we can continue to invest in research and development without being punished by unrestrained infringement," stated Ron Andrews, Chief Executive Officer and Director of TwinStrand. At trial, Guardant Health did not challenge the validity of either of the patents at issue. In advance of the infringement trial, however, Guardant Health filed three petitions to the Patent Trial and Appeal Board on the two patents, with two different petitions filed challenging the validity of all 30 claims of UW's '127 patent on different grounds. The Patent Board refused to review the petition Guardant Health filed on the '631 patent and one of the petitions filed on the '127 patent (further denying Guardant Health's request for a panel rehearing and a Precedential Opinion panel review on that decision). The PTAB did review Guardant Health's second petition on the '127 patent and rejected Guardant Health's invalidity arguments as to all 30 claims of the patent in its final written decision. The patented technology at issue in the case enables the detection of ultra-low frequency DNA mutations with a resolution 10,000 times greater than conventional NGS tools on the market. TwinStrand Duplex Sequencing overcomes the inherent limitations in today's NGS technologies by reducing background noise, which enables quantification and characterization of variants that were previously undetectable, a critical unmet clinical need for blood-based monitoring of certain diseases. TwinStrand and the University of Washington are represented by a team from Sterne Kessler Goldstein & Fox led by Ralph Powers III, Byron Pickard, Chandrika Vira, and William Milliken. About TwinStrand Biosciences TwinStrand Biosciences' Duplex Sequencing patent estate is the foundational technology enabling the ability to accurately identify ultra-low frequency genomic variants that are undetectable by conventional NGS methods. The company's highly sensitive and specific patented Duplex Sequencing technology delivers clearer insights to researchers and clinicians in applications ranging from residual cancer detection to genetic toxicology. This data can inform critical decisions in clinical medicine, public health, and other fields of science on a faster timescale when actions are most impactful. TwinStrand's scientist-leaders have authored more than thirty peer-reviewed articles using Duplex Sequencing technology and have developed a portfolio of more than 150 patents and patent applications. The company has partnered with pharmaceutical companies, academic centers, clinical research networks, molecular diagnostic companies and federal regulatory agencies to bring high precision genomics to the forefront of their science. For more information visit . Media Contact TwinStrand Biosciences Matt Edwards [email protected] SOURCE TwinStrand Biosciences