An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies.
An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies.
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DOI：
10.1158/1078-0432.ccr-16-1098
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发表时间：
2017-03-15
期刊：
影响因子：
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通讯作者：
Philip R
中科院分区：
文献类型：
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作者：
Beaver JA;Tzou A;Blumenthal GM;McKee AE;Kim G;Pazdur R;Philip R
随着技术的发展，诊断从单一生物标志物的检测转向复杂特征，预计复杂特征的临床应用和监管提交将会增加。然而，到目前为止，还没有复杂的签名被批准作为伴随诊断。在本文中，我们将描述复杂签名的潜在好处及其独特的监管挑战，包括分析性能验证、复杂签名模拟和临床性能评估。我们还将审查美国食品和药物管理局（FDA）批准、批准或接受复杂签名的潜在监管途径。这些监管途径包括适用于体外诊断设备的法规，包括伴随诊断设备，作为补充诊断的潜在标签，以及生物标志物鉴定程序。
As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program.