OECD approves application to initiate regulatory acceptance process for ecNGS technology, an improved method for mutagenesis testing.

经合组织批准了启动ecNGS技术监管验收程序的申请，ecNGS技术是一种改进的诱变测试方法。

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.

双链测序ecNGS诱变分析有望为包括制药，食品，化学品和化妆品在内的多个部门的安全评估设定基准，并在全球范围内减少转基因动物的使用。

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.

这一里程碑突显了TwinStrand获得专利的双链测序技术在推进遗传毒理学领域、防止致癌产品进入市场以及确保全球药品和消费品最高安全标准方面的力量。

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).

2024年4月24日，西雅图/PRNewswire/--双链测序技术的先驱TwinStrand Biosciences®，为研究人员提供从遗传毒理学到残留癌症检测等应用的准确见解，宣布经济合作与发展组织（OECD）成功接受标准项目提交表（SPSF）。

This significant milestone will accelerate commencement of the global regulatory acceptance process for error-corrected Next Generation Sequencing (ecNGS) for mutagenesis testing..

这一重要的里程碑将加速全球监管验收过程的启动，以纠正错误的下一代测序（ecNGS）进行诱变测试。。

'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). .

“我们很高兴ecNGS有机会成为经批准的监管遗传毒性测试工具。健康与环境科学研究所遗传毒理学技术委员会（HESI）的康妮·陈表示，通过提高我们评估任何基因组突变频率和频谱的能力，这些方法可以为人类健康提供更精确和信息丰富的数据。。

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.

TwinStrand DuplexSeq™诱变测定法通过提供额外的机理见解而优于传统的诱变方法，有可能减少动物试验，同时增强诱变化合物的检测。双链测序的主要优势在于其以异常的准确性精确检测化学诱导的DNA突变（约1千万分之一）。

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..

这种能力提供了有价值的见解，可以推断与人类癌症直接相关的突变过程。该公司认为，这将通过促进药物开发过程中有问题化合物的鉴定来改变遗传安全，最终节省大量时间和成本。。

'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.

TwinStrand首席执行官罗恩·安德鲁斯（RonAndrews）说：“获得全球批准，使双链测序成为诱变测试的标准，对我们的团队来说是一项巨大的成就。”今天的新闻使我们能够启动我们的商业推广，以充分利用这一机会，并确保我们提供跨不同行业的访问。

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.'.

我们认为，双链测序的多功能适用性，超越了特定的啮齿动物物种和细胞类型，扩展到DNA本身，为简化的遗传毒理学研究提供了重大改进。”。

About TwinStrand Biosciences

关于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.

TwinStrand Biosciences的双链测序是一项基础技术，能够准确识别常规NGS方法无法检测到的超低频基因组变异。该公司的高度敏感和特异的专利双链测序技术为研究人员和临床医生在从残留癌症检测到遗传毒理学的应用中提供了更清晰的见解。

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.

当行动最具影响力时，这些数据可以更快地为临床医学，公共卫生和其他科学领域的关键决策提供信息。TwinStrand的科学家领导者使用双链测序技术撰写了30多篇同行评审的文章，并开发了150多项专利和专利申请。

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 www.twinstrandbio.com..

该公司已与制药公司、学术中心、临床研究网络、分子诊断公司和联邦监管机构合作，将高精度基因组学带入其科学的前沿。有关更多信息，请访问www.twinstrandbio.com。。