SOUTH SAN FRANCISCO, Calif., April 2, 2024 /PRNewswire/ -- Freenome, a biotechnology company pioneering an early cancer detection platform, today announced topline results from PREEMPT CRC, a prospective, registrational clinical study to validate its blood-based test for the early detection of colorectal cancer (CRC) among average-risk adults..

加利福尼亚州南旧金山，2024年4月2日/PRNewswire/-Freenome，一家开创早期癌症检测平台的生物技术公司，今天宣布了PREEMPT CRC的最终结果，这是一项前瞻性注册临床研究，旨在验证其基于血液的检测方法，用于在平均风险成年人中早期发现结直肠癌（CRC）。。

In a prespecified analysis, the Freenome blood test for CRC screening demonstrated 79.2% sensitivity in detecting colorectal cancer (Stage I: 57.1%, Stage II: 100%, Stage III: 82.4%, Stage IV: 100%) with 91.5% specificity for non-advanced colorectal neoplasia. The test also showed 12.5% sensitivity in detecting advanced adenomas (AA), with a sensitivity of 29% for AAs with high-grade dysplasia, also referred to as Stage 0.

在预先指定的分析中，用于CRC筛查的Freenome血液检测在检测结直肠癌方面显示出79.2%的敏感性（I期：57.1%，II期：100%，III期：82.4%，IV期：100%），对非晚期结直肠癌的特异性为91.5%。该测试还显示，检测晚期腺瘤（AA）的敏感性为12.5%，对高度不典型增生（也称为0期）的AA的敏感性为29%。

All endpoints were powered at 96% or greater..

所有端点的供电率均为96%或更高。。

When specificity was adjusted to the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) cut-off of 90%, there was a corresponding increase in the sensitivity for AA (14.8%) while maintaining CRC sensitivity. With the addition of proteins, an improved sensitivity for both AA (16.4%) and CRC (80.5%) at the 90% cut-off was observed.

当将特异性调整为医疗保险和医疗补助服务中心（CMS）全国覆盖率确定（NCD）临界值90%时，AA的敏感性相应增加（14.8%），同时保持CRC敏感性。通过添加蛋白质，观察到在90%截止值下对AA（16.4%）和CRC（80.5%）的敏感性提高。

Additional study findings will be presented at a future scientific meeting..

其他研究结果将在未来的科学会议上提出。。

'These results advance our early cancer detection programs toward mainstream clinical use, and we are grateful to the participants, partners and communities who helped accomplish this study,' said Lance Baldo, M.D., chief medical officer at Freenome. 'PREEMPT CRC was designed and executed with high scientific rigor and generated valuable data and insights that enable near- and long-term test improvements.

Freenome首席医学官兰斯·巴尔多（LanceBaldo）医学博士说：“这些结果将我们的早期癌症检测计划推向了主流临床应用，我们感谢帮助完成这项研究的参与者、合作伙伴和社区。”PREEMPT CRC的设计和执行具有高度的科学严谨性，并产生了有价值的数据和见解，可以实现近期和长期的测试改进。

These clinical performance metrics set a standard from which Freenome will continue to innovate, including the evaluation of prespecified test versioning.' .

这些临床表现指标设定了Freenome将继续创新的标准，包括对预先指定的测试版本的评估。”。

PREEMPT CRC was a prospective, registrational study designed to validate the Freenome blood test for CRC screening. Conducted at more than 200 sites, the study enrolled 48,995 asymptomatic, average-risk adults between the ages of 45 and 85 scheduled to undergo a screening colonoscopy. The results were based on data from the 27,010 eligible participants who enrolled consecutively in the study after a predetermined cut-off date.

PREEMPT CRC是一项前瞻性注册研究，旨在验证Freenome血液检测用于CRC筛查。该研究在200多个地点进行，招募了48995名年龄在45至85岁之间的无症状平均风险成年人，计划接受结肠镜检查。结果基于27010名符合条件的参与者的数据，这些参与者在预定的截止日期后连续参加了研究。

The retained samples from these participants, along with samples from over 16,000 additional participants not utilized in the present analysis, remain available to support future test improvements..

这些参与者保留的样本以及本分析中未使用的另外16000多名参与者的样本仍可用于支持未来的测试改进。。

The study leveraged a hybrid model involving virtual and traditional recruitment methods to reach underserved communities and ensure a representative population that includes people from all 48 states in the continental U.S. In addition, real-world data (RWD) collection through tokenization was integrated into the trial to complement the molecular data with longitudinal clinical outcomes that can be applied to CRC and other early cancer detection applications as part of the company's platform and test versioning roadmap..

该研究利用涉及虚拟和传统招募方法的混合模型，以覆盖服务不足的社区，并确保代表性人群包括来自美国大陆所有48个州的人。此外，通过标记化的真实世界数据（RWD）收集被整合到试验中，以纵向临床结果补充分子数据，这些结果可以应用于CRC和其他早期癌症检测应用，作为公司平台和测试版本路线图的一部分。。

'While physicians have screening tools available for colorectal cancer, the associated inconvenience and discomfort of these methods deter many from getting recommended screenings,' said Aasma Shaukat, M.D., M.P.H., professor of medicine at the NYU Grossman School of Medicine and a principal investigator for the PREEMPT CRC study.

纽约大学格罗斯曼医学院（NYU Grossman School of medicine）医学教授、PREEMPT CRC研究的首席研究员Aasma Shaukat医学博士（M.D.）、医学博士（M.P.H.）说，虽然医生有针对结直肠癌的筛查工具，但这些方法带来的不便和不适阻碍了许多人获得推荐的筛查。

'By providing a more convenient option, Freenome's blood test for the early detection of CRC has the potential to boost screening adherence rates and improve accessibility for people in all communities.'.

“通过提供更方便的选择，Freenome用于早期发现CRC的血液检测有可能提高筛查依从率，并改善所有社区人群的可及性。”。

'In the PREEMPT CRC study, we brought communities together to confront a common enemy – cancer,' said Mike Nolan, chief executive officer at Freenome. 'We built Freenome to be able to integrate many analytes and computational methods into one test to implement a 'staircase' of increasing performance for the benefit of patient care.

Freenome首席执行官迈克·诺兰（MikeNolan）说：“在先发制人的CRC研究中，我们将社区聚集在一起，共同对抗一个共同的敌人——癌症。”我们建立了Freenome，能够将许多分析物和计算方法集成到一个测试中，以实现提高性能的“阶梯”，从而有利于患者护理。

The performance of this initial version establishes a strong foundation and we expect to broaden it to other cancers. Our platform uniquely enables our team to efficiently iterate as we consistently push to achieve what is possible for patients.'.

这个初始版本的表现奠定了坚实的基础，我们希望将其扩展到其他癌症。

About PREEMPT CRCPREEMPT CRC (NCT04369053) was a prospective, registrational clinical study to validate Freenome's blood test for the early detection of colorectal cancer (CRC) among average-risk adults. Initiated in 2020, the study was conducted at more than 200 sites and enrolled 48,995 asymptomatic, average-risk participants between the ages of 45 and 85 scheduled to undergo a screening colonoscopy.

关于PREEMPT CRCPREEMPT CRC（NCT04369053）是一项前瞻性注册临床研究，旨在验证Freenome血液检测在平均风险成年人中早期发现结直肠癌（CRC）。这项研究始于2020年，在200多个地点进行，招募了48995名年龄在45至85岁之间的无症状平均风险参与者，计划接受结肠镜检查。

Freenome and the U.S. Food and Drug Administration agreed upon a predetermined cut-off date for the period most affected by the COVID-19 pandemic. Of the 48,995 participants enrolled, 27,010 were evaluated..

Freenome和美国食品和药物管理局商定了受新型冠状病毒疫情影响最严重时期的预定截止日期。在登记的48995名参与者中，有27010人接受了评估。。

The study leveraged a novel hybrid model involving virtual and traditional recruitment methods to reach underserved communities and ensure a representative population. The decentralized recruitment strategy underscores Freenome's commitment to promoting equity and diversity in clinical studies, ensuring its tests are designed for everyone. .

这项研究利用了一种新颖的混合模型，涉及虚拟和传统招聘方法，以覆盖服务不足的社区并确保有代表性的人群。分散招聘策略强调了Freenome致力于促进临床研究的公平性和多样性，确保其测试为每个人设计。。

Freenome's partners in PREEMPT CRC included the Colorectal Cancer Alliance, Dia de la Mujer Latina, the Intercultural Center for Health Research and Wellness, and historically Black colleges and universities (HBCUs), including Morehouse School of Medicine. Freenome also worked with CVS Health Clinical Trial Services to help drive study enrollment through coordinated communication efforts targeting patients with already scheduled colonoscopies..

Freenome在PREEMPT CRC的合作伙伴包括结直肠癌联盟、Dia de la Mujer Latina、跨文化健康研究与健康中心，以及历史上的黑人学院和大学（HBCUs），包括Morehouse医学院。Freenome还与CVS Health临床试验服务公司合作，通过针对已经计划进行结肠镜检查的患者的协调沟通，帮助推动研究注册。。

About Colorectal CancerThough colorectal cancer (CRC) is curable if detected early, sub-optimal screening rates mean CRC is often detected too late for successful treatment, making it the second cause of cancer deaths in the U.S.2 Nearly twice as many people under the age of 55 are diagnosed with CRC than a decade ago, and more people are dying from the disease each year.3 In response, the U.S.

关于结直肠癌尽管结直肠癌（CRC）如果早期发现是可以治愈的，但次优筛查率意味着CRC经常被发现太迟而无法成功治疗，使其成为美国癌症死亡的第二大原因。2 55岁以下被诊断患有CRC的人数比十年前增加了近一倍，每年有更多的人死于该疾病。

Preventive Services Task Force lowered the screening guidelines for average-risk adults from 50 to 45 years old.4 .

预防服务特别工作组将平均风险成年人的筛查指南从50岁降低到45岁。

Following screening guidelines can improve detection rates, and catching CRC early can lead to better outcomes.4  Despite the effectiveness of screenings in reducing CRC mortality, only 59% of U.S. adults adhere to screening guidelines.5  Recent data show that providing a blood test as a screening option to individuals who previously declined a colonoscopy or stool test increased screening rates.6 .

遵循筛查指南可以提高检出率，早期发现CRC可以带来更好的结果[4]。尽管筛查在降低CRC死亡率方面有效，但只有59%的美国成年人遵守筛查指南[5]。最近的数据显示，为以前拒绝结肠镜检查或粪便检查的人提供血液检查作为筛查选择，可以提高筛查率[6]。

About Freenome Freenome is breaking barriers to early cancer detection with a suite of blood tests built on its multiomics platform. The company recognizes that no single technology can identify every cancer due to the inherent heterogeneity of the disease. Freenome's multimodal approach combines molecular biology and assays with computational biology, machine learning and multiple data types to tune into cancer's subtlest cues, even at the earliest stages of the disease..

关于Freenome Freenome在其多组学平台上建立了一套血液测试，打破了早期癌症检测的障碍。该公司认识到，由于疾病的固有异质性，没有任何一种技术可以识别每种癌症。Freenome的多模式方法将分子生物学和分析与计算生物学，机器学习和多种数据类型相结合，即使在疾病的早期阶段，也可以调整癌症最微妙的线索。。

With the convenience of a standard blood draw, Freenome aims to empower everyone to access recommended cancer screenings. The company is partnering with healthcare organizations and population health decision-makers to integrate its technology and software platform, making cancer detection easier and more accessible.

借助标准抽血的便利性，Freenome旨在使每个人都能够获得推荐的癌症筛查。该公司正在与医疗保健组织和人口健康决策者合作，整合其技术和软件平台，使癌症检测更容易和更容易获得。