子宫内膜异位症患者从出现症状到最终确诊往往需要十年或更长时间1,这一疾病影响全球十分之一的女性1。为了加快诊断速度,多项新型检测技术应运而生。EndoSure是一项耗时约半小时的测试,通过腹部传感器垫测量肠道电信号来检测子宫内膜异位症1;Endotest则分析唾液样本中的microRNAs,结果可在两至三周内出现1。
美国食品药品监督管理局迄今尚未批准这些新测试1。英国国家卫生服务部门最近发布指导建议,推荐在该国使用这两项测试三年时间以收集更多证据1。EndoSure创始人Mark Noar表示公司正在向美国食品药品监督管理局提交申请1,而法国公司Ziwig则采取不需要FDA批准的路径向美国患者提供Endotest1。
尽管这些测试可能有助于加速诊断,但专家认为它们不能替代其他诊断工具,也无法解决医学界对经期疼痛的常态化认识问题1。
Endometriosis, a condition affecting one in ten women globally, has long evaded swift diagnosis, with patients often waiting over a decade from symptom onset to confirmed diagnosis.1 Emerging diagnostic tools are now being deployed internationally to accelerate identification of the disease, though regulatory hurdles and expert caution persist regarding their standalone effectiveness.
Two prominent new tests have gained traction outside the United States. EndoSure, a thirty-minute test that measures electrical signals in the intestines via abdominal sensor pads, has been introduced in multiple countries.1 Endotest, developed by French company Ziwig, analyzes microRNAs in saliva samples with results available within two to three weeks.1 The U.S. Food and Drug Administration has not yet approved either test.1 However, the National Health Service in the United Kingdom recently issued guidance recommending both tests be used in that country over a three-year period to gather additional evidence.1
Efforts to bring these innovations to American patients are underway. EndoSure founder Mark Noar stated the company is submitting an application to the FDA,1 while Ziwig is pursuing a regulatory pathway for Endotest that circumvents FDA approval requirements.1 Experts caution that despite their potential to expedite diagnosis, these new tests cannot replace other diagnostic tools and cannot alone address the medical establishment's normalization of menstrual pain.1
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