WALTHAM, Mass., May 29, 2024 /PRNewswire/ -- Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsy for the early detection of cancer, has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its Mercy Halo™ Ovarian Cancer Screening Test in asymptomatic, postmenopausal women.

马萨诸塞州沃尔瑟姆，2024年5月29日/PRNewswire/--Mercy BioAnalytics，Inc.，一家基于细胞外囊泡的液体活检早期发现癌症的先驱，已获得美国食品和药物管理局（FDA）的突破性设备指定，用于在无症状的绝经后妇女中使用其Mercy Halo™卵巢癌筛查测试。

The Breakthrough Devices program is intended to help give patients more timely access to innovative tests like Mercy Halo that provide more effective diagnosis for life-threatening diseases. There is currently no FDA approved method for ovarian cancer screening.  .

突破性设备计划旨在帮助患者更及时地获得Mercy Halo等创新测试，为威胁生命的疾病提供更有效的诊断。目前还没有FDA批准的卵巢癌筛查方法。。

Ovarian cancer is one of the leading causes of cancer death among women and will kill nearly 13,000 women in the U.S. this year. More than 70% of ovarian cancer is diagnosed in women over 50 years of age, and nearly 80% of ovarian cancer is diagnosed at an advanced stage of disease, when survival is poor..

卵巢癌是女性癌症死亡的主要原因之一，今年将导致美国近13000名女性死亡。超过70%的卵巢癌是在50岁以上的女性中被诊断出来的，近80%的卵巢癌是在生存率很低的晚期被诊断出来的。。

'Mercy is committed to working closely with the FDA to bring our ovarian cancer screening test efficiently through the regulatory process, in order to empower the sixty-three million postmenopausal women in the U.S. with a tool to more proactively manage their health,' said Dawn Mattoon, PhD, Mercy's CEO.

Mercy首席执行官Dawn Mattoon博士说：“Mercy致力于与FDA密切合作，使我们的卵巢癌筛查测试有效地通过监管程序，以便为美国6300万绝经后妇女提供一种更积极管理健康的工具。”。

'The Breakthrough Device Designation for our Mercy Halo Ovarian Cancer Test is recognition of the cutting-edge work being done at Mercy and a major milestone on the path to achieving our mission of saving lives globally through early cancer detection.'.

“我们的Mercy Halo卵巢癌测试的突破性设备设计是对Mercy正在进行的前沿工作的认可，也是我们通过早期癌症检测实现全球拯救生命使命的重要里程碑。”。

On June 3rd, at the upcoming ASCO meeting, Mercy will share data from their landmark study in a poster titled 'Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women.' In this study, Mercy analyzed samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) in which 200,000 women were enrolled, randomized to no screening or annual screening, and followed for up to 20 years.

6月3日，在即将举行的ASCO会议上，Mercy将在一张题为“评估无症状绝经后妇女新型基于细胞外囊泡（EV）的卵巢癌（OC）筛查试验”的海报上分享他们里程碑式研究的数据在这项研究中，Mercy分析了英国卵巢癌筛查合作试验（UKCTOCS）的样本，其中有200000名女性入选，随机分为无筛查或年度筛查，随访长达20年。

All trial participants donated a blood sample at the time of enrollment. Mercy analyzed the blood of more than 1,300 trial participants to assess the sensitivity and specificity of the Mercy Halo test for detecting ovarian cancer up to three years prior to clinical diagnosis. In this study, Mercy Halo outperformed CA125 in both the ability to detect high-grade serous ovarian cancer (82% vs 63% sensitivity), and in test specificity (98% vs 96%), significantly increasing the number of cancers identified while reducing the number of false positives by almost half.

所有试验参与者在登记时都捐赠了血液样本。Mercy分析了1300多名试验参与者的血液，以评估Mercy Halo测试在临床诊断前三年检测卵巢癌的敏感性和特异性。在这项研究中，Mercy Halo在检测高度浆液性卵巢癌（82%比63%敏感性）和测试特异性（98%比96%）方面均优于CA125，显着增加了确定的癌症数量，同时将假阳性数量减少了近一半。

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The Mercy Halo test achieves high sensitivity and specificity through the simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-associated extracellular vesicles. The high abundance of extracellular vesicles in circulation enables the Mercy Halo test to be run on a very small volume of serum or plasma with a simple qPCR-based read-out, unlike cell-free DNA-based tests which typically require a larger volume of blood and next-generation sequencing to generate results..

Mercy-Halo测试通过同时检测共定位在单个肿瘤相关细胞外囊泡表面的多种癌症相关生物标志物来实现高灵敏度和特异性。循环中细胞外囊泡的高丰度使得Mercy-Halo测试能够在非常小体积的血清或血浆上进行，并且具有简单的基于qPCR的读数，这与基于无细胞DNA的测试不同，后者通常需要更大体积的血液和下一代测序才能产生结果。。

About Mercy BioAnalyticsMercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer. Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. The patented Mercy Halo™ liquid biopsy platform utilizes biomarker co-localization to interrogate highly abundant, blood-based extracellular vesicles that carry unique cancer signatures from their parent cells.

关于Mercy BioAnalytics Mercy BioAnalytics，Inc.的使命是通过早期发现癌症来减轻痛苦并挽救生命。早期癌症很难发现，但一旦发现，通常更适合治疗。获得专利的Mercy Halo™液体活检平台利用生物标志物共定位来询问高度丰富的基于血液的细胞外囊泡，这些囊泡携带来自其亲代细胞的独特癌症特征。

The Mercy Halo platform is designed to detect Stage I cancer, when it is most treatable, and enhance the quality of life for cancer patients and their families. Mercy's initial focus is the early detection of ovarian and lung cancers. Ovarian cancer, the most lethal gynecological cancer, typically goes undetected until it is too late to cure.

Mercy Halo平台旨在检测最可治疗的I期癌症，并提高癌症患者及其家属的生活质量。Mercy最初的重点是早期发现卵巢癌和肺癌。卵巢癌是最致命的妇科癌症，通常在治愈为时已晚时才被发现。

Lung cancer, the number one cancer killer, takes more lives than breast and prostate cancers combined..

肺癌是头号癌症杀手，比乳腺癌和前列腺癌加起来夺去的生命还要多。。

SOURCE Mercy BioAnalytics

SOURCE Mercy生物分析