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What's New PreMD Seeks Expanded Regulatory Claim for Skin Cholesterol Test

机译:PreMD寻求针对皮肤胆固醇测试的法规要求扩大

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摘要

Predictive medicine company PreMD Inc. has filed an application with the FDA seeking an expanded claim for its skin cholesterol test (Prevu(x) POC). The submission seeks to obtain broader clearance for use of the test in the assessment of risk of cardiovascular disease in individuals without known or suspected disease. The approval of a broader claim would make it the first cost-effective, noninvasive test to aid in the assessment of carotid intima media thickness (CIMT) and the presence of carotid plaques-established markers for future heart attacks and strokes-in patients without known coronary artery disease, cere-brovascular disease, or peripheral artery disease.
机译:预测性药物公司PreMD Inc.已向FDA提出申请,要求对其皮肤胆固醇测试(Prevu(x)POC)扩大索赔。该提交文件寻求获得更广泛的许可,以便将该测试用于评估无已知或疑似疾病的个体患心血管疾病的风险。批准更广泛的要求将使其成为第一个成本有效,无创性测试,可帮助评估未知患者的颈动脉内膜中层厚度(CIMT)和颈动脉斑块的存在,为将来的心脏病发作和中风建立了标记冠状动脉疾病,脑血管疾病或外周动脉疾病。

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