KDx Diagnostics announces FDA Breakthrough Device designation for URO17™, Innovative urine test for Bladder Cancer

KDx Diagnostic公司用于膀胱肿瘤复发检测URO17™获FDA突破性设备称号

2020-01-09 14:48:34 CISION

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 KDx Diagnostics, Inc. , announced today that the Food and Drug Administration has granted "Breakthrough Device" designation for its URO17™ Bladder Cancer Recurrence Test. This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing. Bladder cancer is the 6th most common cancer in the US, and 81,000 people are newly diagnosed with the disease annually. Moreover, bladder cancer has a relatively high recurrence rate and is one of the most expensive patients to treat, in part because patients must be regularly monitored for recurrence.  KDx has published data (Babu et al., 2018) showing the URO17™ test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples. While this was an initial study, these rates are among the best ever reported for a non-invasive test.  "The FDA's designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics. Breakthrough Device designation significantly enhances our ability to conduct the necessary clinical trials for approval and expedites the review process. We look forward to working closely with the FDA during this next exciting phase of product development," said Nam W. Kim, Ph.D., KDx' Co-Founder and CEO. About KDx Diagnostics, Inc. Founded in 2017, KDx is focused on developing non-invasive cancer tests to improve early detection and therapy decisions in cancer. The URO17™ bladder cancer test developed by KDx may prove to be the most sensitive and specific test for bladder cancer developed to date. KDx plans to develop tests based on the same biomarker for other platforms and sample types and expand its product line into other cancer diagnostic tests.  Contact:Public RelationsKDx Diagnostics Inc.408-628-7715info@kdxdiagnostics.com URO17 is a trademark of KDx. Forward-Looking Statements  KDx cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to planned clinical studies and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause KDx's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in KDx's business and other risks in KDx's filings with the Securities and Exchange Commission (the SEC). KDx's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. KDx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. SOURCE KDx Diagnostics Inc. Related Links https://www.kdxdiagnostics.com/
KDx Diagnostics , Inc .今天宣布,美国食品药品监督管理局(Food and Drug Administration)已经为其 URO17™膀胱肿瘤复发试验授予了“突破装置”称号。这项革命性的新测试利用了一个新的癌症标记,可以显着提高非侵袭性膀胱癌测试的准确性和敏感性。 膀胱癌是美国第六大常见的癌症,每年有8.1万人被诊断为该病。此外,膀胱癌的复发率相对较高,是最昂贵的治疗病人之一,部分原因是必须定期监测病人的复发。 KDx 公布的数据( Babu 等人,2018年)显示, URO17™测试在检测尿样复发膀胱癌方面显示出100%的敏感性和96%的特异性。虽然这是一项初步的研究,这些比率是有史以来最好的非侵入性测试报告。 美国食品和药物管理局( FDA )指定的 URO17测试的突破装置,证实了我们的兴奋之情,我们的测试,以改善膀胱癌治疗的潜力,伴随着对膀胱癌诊断市场的重大影响。突破性器械的指定大大增强了我们进行必要临床试验以获得批准的能力,加快了审查进程。我们期待着在下一个令人兴奋的产品开发阶段与 FDA 密切合作。 关于 KDx 诊断公司。 KDx 成立于2017年,专注于开发无创肿瘤检测,以改善癌症的早期检测和治疗决策。KDx 开发的 URO17™膀胱癌测试可能是迄今为止最敏感和最具体的膀胱癌测试。KDx 计划为其他平台和样本类型开发基于相同生物标志物的测试,并将其产品线扩展到其他癌症诊断测试。 联系人:公共关系 KDx Diagnostics Inc.408-628-7715info @ kdxDiagnostics.com URO17是 KDx 的商标。 前瞻性陈述 KDx 提醒您,除了历史事实陈述之外,本新闻稿中的所有陈述都是前瞻性陈述。前瞻性陈述,在某些情况下,可以通过诸如“相信”、“可能”、“将”、“估计”、“继续”、“预期”、“设计”、“打算”、“预期”、“可以”、“计划”、“潜力”、“预测”、“寻找”、“应该”、“会”、“思考”、“项目”、“目标”、“倾向”等术语来识别,或者这些单词和类似表达的否定版本。此类声明包括但不限于与计划的临床研究和与监管机构的会议有关的声明。前瞻性陈述涉及已知和未知的风险、不确定性和其他因素,可能导致 KDx 的实际结果、业绩或成就与本新闻稿中前瞻性陈述所表达或暗示的未来结果、业绩或成就存在重大差异,包括 KDx 业务固有的风险和不确定性以及 KDx 向美国证券交易委员会( SEC )提交的文件中的其他风险。KDx 的前瞻性陈述基于其当前的预期,并涉及可能永远不会实现或可能证明不正确的假设。所有前瞻性陈述都明确通过这些警告声明对其整体进行限定。请注意不要过分依赖前瞻性陈述,这些陈述仅说明作出声明的日期。KDx 不承担更新此类声明的义务,以反映发生的事件或在声明做出之日之后存在的情况,除非法律要求。 SOURCE KDx 诊断公司。 相关链接 https://www.kdxDiagnostics.com/

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