Multianalyte Tests for the Early Detection of Cancer: Speedbumps and Barriers
Multianalyte Tests for the Early Detection of Cancer: Speedbumps and Barriers
复制标题
用于癌症早期检测的多分析物测试：减速带和障碍
DOI：
10.4137/117727190700200037
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发表时间：
2007
影响因子：
3.8
通讯作者：
J. Abrams
中科院分区：
文献类型：
--
作者：
M. Tainsky;Madhumita Chatterjee;N. Levin;S. Drăghici;J. Abrams
很明显，单个分子事件不足以准确预测癌症的生物学（或病理生理学）。此外，使用任何单个分子事件作为恶性肿瘤早期检测的生物标志物可能无法全面识别大多数患有该疾病的个体。因此，可以同时检测几种，可能是数百种生物标志物的技术已经出现的事实已经推动了该领域朝着使用体液如血清、血浆、痰、唾液或尿液开发基于多分析物的癌症体外诊断早期检测测试。这些多分析物测试可以基于对肿瘤抗原的血清自身抗体的检测，血清中癌症相关蛋白的存在，或在血浆中以游离DNA形式出现的肿瘤特异性基因组变化的存在。实施非侵入性诊断方法来检测早期癌症可以为医生提供癌症的证据，但问题是这些信息将如何影响临床干预的途径。确认体外诊断癌症试验的阳性结果可能涉及相对侵入性的程序，以建立真正的癌症诊断。如果体外诊断测试被证明是特异性的，即由于不相关的条件很少产生假阳性结果，并且足够敏感，即很少产生假阴性结果，那么这样的筛选测试提供了使用多种疾病相关靶标以方便和非侵入性手段进行早期检测和个性化治疗的可能性。在这里，我们讨论的技术和监管障碍固有的临床多分析物生物标志物检测的发展。
It has become very clear that a single molecular event is inadequate to accurately predict the biology (or pathophysiology) of cancer. Furthermore, using any single molecular event as a biomarker for the early detection of malignancy may not comprehensively identify the majority of individuals with that disease. Therefore, the fact that technologies have arisen that can simultaneously detect several, possibly hundreds, of biomarkers has propelled the field towards the development of multianalyte-based in vitro diagnostic early detection tests for cancer using body fluids such as serum, plasma, sputum, saliva, or urine. These multianalyte tests may be based on the detection of serum autoantibodies to tumor antigens, the presence of cancer-related proteins in serum, or the presence of tumor-specific genomic changes that appear in plasma as free DNA. The implementation of non-invasive diagnostic approaches to detect early stage cancer may provide the physician with evidence of cancer, but the question arises as to how the information will affect the pathway of clinical intervention. The confirmation of a positive result from an in vitro diagnostic cancer test may involve relatively invasive procedures to establish a true cancer diagnosis. If in vitro diagnostic tests are proven to be both specific, i.e. rarely produce false positive results due to unrelated conditions, and sufficiently sensitive, i.e. rarely produce false negative results, then such screening tests offer the potential for early detection and personalized therapeutics using multiple disease-related targets with convenient and non-invasive means. Here we discuss the technical and regulatory barriers inherent in development of clinical multianalyte biomarker assays.
影响因子：
56.9
作者：
S. Tomlins;D. Rhodes;S. Perner;S. Dhanasekaran;R. Mehra;Xiao-wei Sun;S. Varambally;Xuhong Cao
通讯作者：
S. Tomlins;D. Rhodes;S. Perner;S. Dhanasekaran;R. Mehra;Xiao-wei Sun;S. Varambally;Xuhong Cao
影响因子：
158.5
作者：
Wang, XJ;Yu, JJ;Chinnaiyan, AM
通讯作者：
Chinnaiyan, AM