Prospective VA screening study demonstrates excellent EsoGuard sensitivity of 92.9% and negative predictive value of 98.6% compared to upper gastrointestinal endoscopy

前瞻性VA筛查研究显示，与上消化道内窥镜检查相比，EsoGuard的敏感性为92.9%，阴性预测值为98.6%

Authors conclude that EsoGuard is a 'powerful screening tool' for esophageal precancer and cancer

作者得出结论，EsoGuard是食管癌前病变和癌症的“强大筛查工具”

NEW YORK, March 21, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ('Lucid' or the 'Company'), a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ( 'PAVmed'), today announced that investigators at the Louis Stokes Cleveland Veterans Affairs Medical Center, led by Katarina B.

纽约，2024年3月21日/PRNewswire/--Lucid Diagnostics Inc.（纳斯达克：LUCD）（“Lucid”或“公司”），一家商业舞台，癌症预防医学诊断公司，以及PAVmed Inc.（纳斯达克：PAVM，PAVMZ）（“PAVMZ”）的控股子公司，今天宣布由Katarina B领导的路易斯·斯托克斯克利夫兰退伍军人事务医疗中心的调查人员。

Greer, M.D.,M.S., Associate Professor of Medicine at Case Western Reserve University School of Medicine, have released data from a Department of Defense funded prospective clinical validation study of patients who met strict national society guideline criteria for esophageal precancer testing. The study demonstrated excellent performance of Lucid's EsoGuard® Esophageal DNA test for esophageal precancer detection and is the first to present such clinical validity data in a screening population.

凯斯西储大学医学院医学副教授、医学博士格里尔（Greer）发布了一项由国防部资助的前瞻性临床验证研究的数据，该研究对符合严格的国家学会食管癌前检测指南标准的患者进行了研究。该研究证明了Lucid的EsoGuard®食管DNA检测在食管癌前病变检测中的出色表现，并且是第一个在筛查人群中提供此类临床有效性数据的研究。

The manuscript entitled Non-endoscopic screening for Barrett's esophagus and Esophageal Adenocarcinoma in at risk Veterans is available on the leading health sciences preprint server, medRxiv, pending peer review and publication..

题为“高危退伍军人巴雷特食管和食管腺癌的非内镜筛查”的手稿可在领先的健康科学预印本服务器medRxiv上获得，等待同行评审和出版。。

'We are grateful to Dr. Greer and her co-investigators for this sentinel contribution to the clinical evidence supporting EsoGuard esophageal precancer testing,' said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. 'Data from this clinical validation study, the first in an 'intended use' screening population, closely mirror EsoGuard performance data from two previously reported NCI-funded case-control clinical validation studies—the original multi-center study which first introduced the technology, and the recently completed BETRNet study whose results were posted as a preprint last year pending peer review and publication.

Lucid首席医疗官维多利亚·T·李（VictoriaT.Lee）医学博士说：“我们感谢格里尔博士和她的联合研究人员为支持EsoGuard食管癌前检测的临床证据做出的这一前哨贡献。”来自这项临床验证研究的数据是“预期用途”筛查人群中的第一个数据，与之前报道的两项由NCI资助的病例对照临床验证研究（最初引入该技术的多中心研究）和最近完成的BETRNet研究（其结果于去年作为预印本发布，等待同行评审和出版）的EsoGuard性能数据非常相似。

Collectively, these three clinical validity studies demonstrate excellent EsoGuard sensitivity and negative predictive value, including unprecedented performance of a molecular diagnostic test in detecting a precancer. They strongly support EsoGuard's use as a widespread screening tool to prevent esophageal cancer through the early detection of esophageal precancer.'.

总的来说，这三项临床有效性研究显示出优异的EsoGuard敏感性和阴性预测价值，包括分子诊断测试在检测癌前病变方面前所未有的表现。他们强烈支持EsoGuard作为一种广泛的筛查工具，通过早期发现食管癌前病变来预防食管癌。”。

Dr. Lee added, 'as previously reported, three published clinical utility studies have already documented near-perfect concordance between EsoGuard results and physician referral for upper gastrointestinal endoscopy. Physicians consistently utilized EsoGuard results to appropriately triage at-risk patients resulting in more cost-effective utilization of endoscopy for esophageal precancer detection.

Lee博士补充道，“正如之前报道的那样，三项已发表的临床效用研究已经证明EsoGuard的结果与医生转诊上消化道内窥镜检查的结果几乎完全一致。医生一直利用EsoGuard的结果对高危患者进行适当的分类，从而更具成本效益地利用内窥镜检查进行食管癌前病变检测。

The clinical validity and clinical utility data, coupled with multiple national society guidelines and consensus statements supporting EsoGuard esophageal precancer detection, provides a strong foundation of critical evidence needed to support broad EsoGuard medical policy coverage and a line of sight to CMS coverage, in particular.'.

临床有效性和临床实用性数据，加上支持EsoGuard食管癌前病变检测的多项国家社会指南和共识声明，为支持广泛的EsoGuard医疗政策覆盖范围和CMS覆盖范围所需的重要证据提供了坚实的基础。

The manuscript reports on 128 eligible patients with no prior history of upper gastrointestinal endoscopy (EGD) who met criteria for esophageal precancer screening based on current American College of Gastroenterology guidelines (presence of chronic heartburn and at least three of six additional risk factors—age over 50 years, male sex, white race, obesity, smoking and positive family history).

这份手稿报告了128名符合条件的患者，这些患者没有上消化道内窥镜检查（EGD）的既往病史，他们符合根据当前美国胃肠病学会指南进行食管癌前筛查的标准（存在慢性胃灼热和六个额外危险因素中的至少三个年龄超过50岁，男性，白人，肥胖，吸烟和阳性家族史）。

124 patients underwent successful non-endoscopic esophageal cell sampling using the EsoCheck® Cell Collection Device followed by EGD. Biopsies were performed during EGD if esophageal precancer was suspected based on appearance. Twelve patients with esophageal precancer and two patients with esophageal cancer were confirmed on endoscopy for an overall disease prevalence of 12.9%.

124名患者使用EsoCheck®细胞采集装置和EGD成功进行了非内镜食管细胞采样。如果根据外观怀疑食管癌前病变，则在EGD期间进行活检。内镜检查证实12例食管癌前病变患者和2例食管癌患者的总体疾病患病率为12.9%。

111 patients had sufficient DNA for EsoGuard analysis.  EsoGuard sensitivity and specificity were 92.9% and 72.2%, respectively. Negative and positive predictive were 98.6% and 32.5% respectively. Although specificity was somewhat lower than in prior studies—likely due to the absence of routine biopsies of the gastroesophageal junction, absence of biopsies in patients with minimal or no suspicious areas on EGD, a higher mean age, and higher proportion of current smokers—a solid positive predictive value was preserved, resulting in a 2.5-fold increase in the positive yield of EGD.

111名患者有足够的DNA用于EsoGuard分析。EsoGuard敏感性和特异性分别为92.9%和72.2%。阴性和阳性预测分别为98.6%和32.5%。虽然特异性略低于先前的研究，可能是由于缺乏胃食管交界处的常规活检，EGD可疑区域最小或无可疑区域的患者没有活检，平均年龄较高，当前吸烟者比例较高-保留了可靠的阳性预测值，导致EGD阳性率增加2.5倍。

Good tolerance and acceptability of EsoCheck cell sampling was also reported..

还报道了EsoCheck细胞取样的良好耐受性和可接受性。。

The authors conclude that '[g]iven the increasing prevalence of [esophageal cancer]… and improved effectiveness of ablative and endoscopic resection techniques available to patients with early stages of disease, this screening platform [EsoGuard] opens the window to improved prognosis for [esophageal cancer] by increasing access to minimally invasive, well tolerated office-based testing.'.

作者得出的结论是，“[g]促进了[食管癌]的患病率增加……并且提高了疾病早期患者可用的消融和内镜切除技术的有效性，这个筛查平台[EsoGuard]通过增加微创，耐受性良好的办公室测试，为改善[食管癌]的预后打开了窗口。”。

About Lucid DiagnosticsLucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer.

关于Lucid Diagnostics Lucid Diagnostics Inc.是一家商业性的癌症预防医学诊断公司，也是PAVmed Inc.（纳斯达克：PAVM）的子公司。Lucid专注于数百万胃食管反流病（GERD）患者，也称为慢性胃灼热，他们有患食管癌前病变和癌症的风险。

Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients..

Lucid的EsoGuard®食管DNA测试，使用其EsoCheck®食管细胞采集装置对在一个简短的非侵入性办公室程序中采集的样本进行，这是第一个也是唯一一个商业上可用的工具，旨在通过广泛，早期发现高危患者的食管癌前病变来预防癌症和癌症死亡。。

For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

欲了解更多信息，请访问www.luciddx.com；欲了解其母公司PAVmed的更多信息，请访问www.PAVmed.com。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements.

本新闻稿包括涉及风险和不确定性的前瞻性声明。前瞻性陈述是指任何非历史事实的陈述。此类基于Lucid管理层当前信念和期望的前瞻性声明存在风险和不确定性，这可能导致实际结果与前瞻性声明不同。

Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments.

可能导致此类差异的风险和不确定性包括Lucid普通股价格的波动性等；一般经济和市场状况；研究和开发中固有的不确定性，包括将Lucid的产品提交监管机构所需的成本和时间；监管机构是否会对Lucid的临床和临床前研究的设计和结果感到满意；Lucid的产品是否以及何时获得监管机构的批准；Lucid产品一旦获得许可并商业化，市场就会接受；Lucid能够根据需要筹集额外资金；以及其他竞争发展。

In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict.

此外，Lucid继续监测新型冠状病毒大流行以及大流行对Lucid业务的影响。这些因素很难或不可能准确预测，其中许多因素超出了Lucid的控制范围。此外，新的风险和不确定性可能不时出现，难以预测。

For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, 'Risk Factors,' in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, 'Risk Factors' in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics.

有关这些以及其他可能影响Lucid未来运营的重要风险和不确定性的进一步列表和描述，请参阅Lucid提交给证券交易委员会的最新10-K表年度报告中的第一部分第1A项“风险因素”，以及Lucid Diagnostics提交的任何10-Q表季度报告中第二部分第1A项“风险因素”的更新。

SOURCE Lucid Diagnostics

SOURCE Lucid诊断