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TwinStrand Biosciences Initiates Regulatory Approval Process for Duplex Sequencing Mutagenesis Assays with OECD

  • 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


TwinStrand Biosciences

Matt Edwards

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SOURCE TwinStrand Biosciences

By: PR Newswire Association LLC. - 24 Apr 2024
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