American College of Gastroenterology (ACG) gives BLUE-C study late breaker status at 2023 annual meeting with presentation of the only head-to-head study results versus FIT at ACG High specificity for next-generation Cologuard test expected to minimize unnecessary follow-up colonoscopies, supporting positive patient experiences1MADISON, Wis., Oct.

美国胃肠病学会（ACG）在2023年的年会上提供了BLUE-C研究的后期破坏者状态，并介绍了ACG唯一的头对头研究结果与FIT的对比。ACG对下一代Cologuard测试的高度特异性预计将最大限度地减少不必要的随访结肠镜检查，支持积极的患者体验1Madison，Wis。，Oct。

22, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard® test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer (CRC) at 91% specificity, during the American College of Gastroenterology (ACG) Annual Meeting 2023.[1] Additionally, results show the next-generation Cologuard test was significantly more likely to detect cancer or precancer than fecal immunochemical testing (FIT)* (94% vs 67% and 43% vs 23%, respectively).[1]  Finally, the next-generation Cologuard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions (high-grade dysplasia at 75%) than FIT (47%).[1]    .

222023/PRNewswire/-Exact Sciences Corp.（纳斯达克股票代码：EXAS）是癌症筛查和诊断测试的领先供应商，今天宣布关键的BLUE-C试验的最新数据显示，下一代Cologuard®测试符合所有研究终点，特异性为91%，对结直肠癌（CRC）的敏感性为94%，在美国胃肠病学会（ACG）2023年会期间。[1]此外，结果显示，与粪便免疫化学检测（FIT）*（94%vs 67%）相比，下一代Cologuard检测更有可能检测到癌症或癌前病变。%和43%对23%）。[1] 最后，下一代Cologuard测试显示，对于临床上最显着形式的晚期癌前病变（75%的高度不典型增生）的敏感性高于FIT（47%）。[1]    .

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BLUE-C is one of the largest, most robust CRC screening trials ever conducted. It included more than 20,000 evaluable subjects in a population that aligns to the racial and ethnic diversity of the United States.[1,2] Among these participants, the BLUE-C trial identified a total of 98 participants with colorectal cancer.

BLUE-C是有史以来最大，最强大的CRC筛查试验之一。它包括与美国种族和族裔多样性相一致的人口中的20000多名可评估受试者。[1,2]在这些参与者中，BLUE-C试验共鉴定了98名结直肠癌患者。

Of these 82 (83.7%) had stage I to III cancers.[1]  .

这82例（83.7%）患有I〜III期癌症。[1]  .

Results show next-generation Cologuard test superior to FIT in sensitivity for colorectal cancer and pre-cancers

结果显示，下一代Cologuard测试在结直肠癌和癌前病变的敏感性方面优于FIT

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'BLUE-C results demonstrate a new standard in non-invasive colorectal cancer and precancer detection, building on the strengths of current Cologuard,' said Paul Limburg, MD, MPH, AGAF, chief medical officer, Screening, Exact Sciences. 'The high sensitivity and specificity reported in BLUE-C will help drive improvement in patient experiences and will contribute to our quest to improve outcomes for this deadly cancer via accurate early detection.'.

“BLUE-C结果显示了非侵入性结直肠癌和癌前检测的新标准，基于当前Cologuard的优势，”医学博士，公共卫生硕士，AGAF，首席医疗官，筛选，Exact Sciences。Paul Limburg说BLUE-C报道的高灵敏度和特异性将有助于推动患者体验的改善，并将有助于我们通过准确的早期检测来改善这种致命癌症的预后。

Most advanced colonoscopy finding (index lesion)

最先进的结肠镜检查结果（指标病变）

Next-gen Cologuard (N=20,176)

下一代Cologuard（N=20176）

FIT (N=20,176)

适合（N=20176）

Sensitivity (%)

灵敏度（%）

Sensitivity (%)

灵敏度（%）

CRC, any

CRC，任何

94

94

67

67

Stage I-III

阶段I-III

93

93

65

65

Advanced Pre-Cancerous Lesions (APLs)

晚期癌前病变（APL）

43

43

23

23

High-grade dysplasia

高度不典型增生

75

75

47

47

Note: FIT positivity cut-off: hemoglobin >100 ng/mL. Colorectal cancer stages were defined per the American Joint Committee on Cancer Staging System, 8th ed.BLUE-C Reports High SpecificityIn addition to superiority over FIT in sensitivity for both colorectal cancer and advanced precancerous lesions, the next-generation Cologuard test demonstrated 91% specificity.1 The specificity for FIT was 95%.[1] 'Improving specificity of non-invasive stool-based screening tests while maintaining high sensitivity is a critical step in advancing the detection and prevention of colorectal cancer and minimizing the potential for unnecessary follow-up colonoscopies,' said Thomas F.

注意：FIT阳性截止值：血红蛋白>100 ng/mL。结直肠癌分期根据美国癌症分期系统联合委员会第8版定义.BLUE-C报告高特异性除了对结直肠癌和晚期癌前病变的敏感性优于FIT之外，下一代Cologuard测试显示91%特异性.1 FIT的特异性为95%。[1] 托马斯F说：“提高非侵入性粪便筛查试验的特异性，同时保持高灵敏度，是推进结直肠癌检测和预防，尽量减少不必要的随访结肠镜检查的可能性的关键步骤。”。

Imperiale, MD, Professor of Medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for BLUE-C.The 91% specificity reported in the BLUE-C trial for patients without advanced neoplasia is higher than the 87% specificity reported in Deep-C, the FDA registrational trial for Cologuard.[1,3] For patients with a negative or non-neoplastic  findings on colonoscopy, specificity for the next-generation Cologuard test reached 93%.

Imperiale，医学博士，印第安纳大学医学院医学教授，Regenstrief研究所研究科学家和BLUE-C首席研究员.BLUE-C试验报告的无晚期肿瘤患者的91%特异性高于87%在Deep-C（FDA Cologuard注册试验）中报告的特异性。[1,3]对于结肠镜检查结果为阴性或非肿瘤性的患者，下一代Cologuard检测的特异性达到93%。

In this category, the specificity for FIT was 96%.[1]  Additional Analysis Presented at ACG Further Supports Performance of Next-Generation Cologuard In addition to the BLUE-C pivotal data shared at ACG, Exact Sciences presented an analysis that describes a performance evaluation and validation of the next-generation Cologuard algorithm using a set of known test samples from the original Cologuard pivotal study (DeeP-C).

在这一类别中，FIT的特异性为96%。[1] ACG提供的其他分析进一步支持下一代Cologuard的性能除了ACG共享的BLUE-C关键数据外，Exact Sciences还提供了一项分析，描述了使用一组已知数据对下一代Cologuard算法进行性能评估和验证来自原始Cologuard关键研究（DeeP-C）的测试样本。

In this additional analysis, all performance estimates of next-generation Cologuard performance were equivalent to or higher than the first-generation Cologuard test, confirming reproducibility and supp.

在此附加分析中，下一代Cologuard性能的所有性能估算值均等于或高于第一代Cologuard测试，从而确认了可重复性和supp。

Imperiale T, et al. Oral Presentation 54, ACG 2023.

Imperiale T等人口头报告54，ACG 2023。

United States Census Bureau. Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2020 to July 1, 2022 (NC-EST2022-AGESEX-RES). Accessed 16 October 2023. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html

美国人口普查局。按美国单年龄和性别分列的常住人口年度估计：2020年4月1日至2022年7月1日（NC-EST2022-AGESEX-RES）。访问时间：2023年10月16日https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html

Imperiale TF, et al. N Engl J Med. 2014;370(14):1287-1297.

Imperiale TF等人，《英国医学杂志》，2014；370（14）：1287-1297。

Imperiale T, et al. P0358, ACG 2023.

Imperiale T等人，P0358，ACG 2023。

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