ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC..

圣路易斯--（商业新闻短讯）--专注于开发胃肠健康诊断测试的生命科学公司Geneoscopy，Inc.今天宣布，美国食品和药物管理局（FDA）批准了其无创性结直肠癌筛查测试ColoSense。ColoSense是针对45岁或以上的成年人进行的筛查测试，这些成年人通常具有患CRC的平均风险。。

Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1-2.

ColoSense被FDA指定为突破性设备，是第一个通过使用RNA生物标志物提供疾病活动动态视图的无创结直肠癌筛查测试。RNA生物标志物不受年龄相关甲基化模式的影响，这可能导致不同年龄组的测试表现存在差异。

“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy.

Geneoscopy首席执行官兼联合创始人安德鲁·巴内尔（AndrewBarnell）表示：“获得FDA对ColoSense的批准标志着Geneoscopy的一个重要里程碑，并证明我们获得专利的RNA技术可以为数百万符合条件的成年人提供一种安全有效的检测CRC和晚期腺瘤的选择。”。

“This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”.

“这一成就证明了我们对将创新技术推向市场的深切奉献和承诺，这将改善这种致命但可预防的疾病的结果。”。

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment.

Geneoscopy的CRC-PREVENT试验评估了来自不同种族，种族和社会经济背景的45岁及以上的参与者。使用一种新的分散登记方法，64%的参与者从未接受过结直肠癌筛查，68%的参与者在登记时没有安排结肠镜检查。

This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable.

这与传统的集中试验不同，在传统的集中试验中，患者通常已经参与了医疗保健筛查计划。在平均风险个体中，ColoSense成功证明了对CRC的93%敏感性，并且重要的是在疾病最可治愈的第一阶段确定了100%的CRC。

Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic..

此外，当疾病最可预防时，ColoSense检测到45%的晚期腺瘤。值得注意的是，该研究报告了45-49岁患者的100%CRC敏感性和44%AA敏感性，这是一个至关重要的筛查人群。。

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force's guidelines to recommend initiation of CRC screening at age 45.3 Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.5,6.

结直肠癌是美国第二大致命癌症。然而，由于缺乏或避免结肠镜检查等侵入性选择，数百万符合条件的美国人没有接受筛查。在50岁以下的年轻人群中，CRC发病率也在上升，促使美国预防服务工作组的指南最近发生了变化，建议在45岁时开始CRC筛查。美国癌症协会最近报告说，结直肠癌现在是男性癌症死亡的主要原因，也是50岁以下女性死亡的第二大原因。这进一步加剧了这一挑战，大约40%的未经筛查和符合条件的美国人年龄在45-49.5,6岁之间。

“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It's essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC.

“越来越多的成年人被诊断患有结直肠癌，这突显出迫切需要创新的筛查方法。消除障碍，扩大医疗保健提供者和患者筛查方法的可用性至关重要，”Fight CRC总裁安吉·戴维斯（Anjee Davis）说。

“We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”.

“我们希望引入新的FDA批准的诊断工具，包括基于粪便的检测，如ColoSense，将有助于提高获取率和筛查率，最终减少晚期结直肠癌诊断的影响。”。

FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening.

FDA批准ColoSense是向患者提供这一重要筛查工具的重要一步。Geneoscopy正在与付款人、专业协会和倡导合作伙伴合作，支持今年晚些时候或2025年初的商业启动，以确保患者能够及时访问ColoSense以支持CRC筛查。

Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services..

Geneoscopy将与创新和综合实验室服务的全球领导者Labcorp（纽约证券交易所：LH）合作推出ColoSense。。

About ColoSense

关于ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System.

ColoSense旨在定性检测结直肠肿瘤相关的RNA标记物以及人类粪便中隐匿性血红蛋白的存在。ColoSense与ColoSense采集试剂盒、ColoSense测试试剂盒、ColoSense软件和以下仪器一起使用：Polymedco iFOBT分析仪；bioMérieux EMAG核酸提取系统；和Bio-Rad QXDx ddPCR系统。

ColoSense is a single-site test performed at Geneoscopy, Inc..

ColoSense是在Geneoscopy，Inc.进行的单点测试。。

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.

结肠镜检查结果阳性可能表明存在结直肠癌（CRC），晚期腺瘤（AA）或锯齿状癌前病变（SPL），应随后进行结肠镜检查。ColoSense是针对45岁或以上的成年人进行的筛查测试，这些成年人具有患CRC的典型平均风险。

ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals..

ColoSense不能替代高危人群的诊断性结肠镜检查或监视性结肠镜检查。。

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

Geneoscopy关键的CRC-PREVENT试验的结果于2023年10月发表在《美国医学会杂志》（JAMA）上。有关更多信息，请访问www.colosense.com。

About Geneoscopy, Inc.

关于Geneoscopy，Inc。

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics.

Geneoscopy，Inc.是一家生命科学公司，专注于开发胃肠道健康诊断测试。Geneoscopy利用其专有的专利粪便来源的真核RNA（seRNA）生物标志物平台，其使命是使患者和提供者能够通过创新诊断来改变胃肠道健康。

Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn..

除了结直肠癌筛查之外，Geneoscopy正在与领先的大学和生物制药公司合作，为其他疾病领域的治疗选择和治疗监测开发诊断测试。有关更多信息，请访问www.geneoscopy.com并在LinkedIn上关注该公司。。