Clinical Microarray Core, Department of Pathology & Laboratory Medicine, University of California at Los Angeles, 1000 Veteran Ave., Los Angeles, CA 90095, USA.
Curr Genomics. 2008 Nov;9(7):466-74. doi: 10.2174/138920208786241199.
Microarray-based clinical tests have become powerful tools in the diagnosis and treatment of diseases. In contrast to traditional DNA-based tests that largely focus on single genes associated with rare conditions, microarray-based tests are ideal for the study of diseases with underlying complex genetic causes. Several microarray based tests have been translated into clinical practice such as MammaPrint and AmpliChip CYP450. Additional cancer-related microarray-based tests are either in the process of FDA review or under active development, including Tissue of Tumor Origin and AmpliChip p53. All diagnostic microarray testing is ordered by physicians and tested by a Clinical Laboratories Improvement Amendment-certified (CLIA) reference laboratory. Recently, companies offering consumer based microarray testing have emerged. Individuals can order tests online and service providers deliver the results directly to the clients via a password-protected secure website. Navigenics, 23andMe and deCODE Genetics represent pioneering companies in this field. Although the progress of these microarray-based tests is extremely encouraging with the potential to revolutionize the recognition and treatment of common diseases, these tests are still in their infancy and face technical, clinical and marketing challenges. In this article, we review microarray-based tests which are currently approved or under review by the FDA, as well as the consumer-based testing. We also provide a summary of the challenges and strategic solutions in the development and clinical use of the microarray-based tests. Finally, we present a brief outlook for the future of microarray-based clinical applications.
基于微阵列的临床测试已成为疾病诊断和治疗的有力工具。与传统的主要关注与罕见疾病相关的单个基因的基于 DNA 的测试相比，基于微阵列的测试是研究具有潜在复杂遗传原因的疾病的理想选择。已经有几种基于微阵列的测试转化为临床实践，例如 MammaPrint 和 AmpliChip CYP450。其他与癌症相关的基于微阵列的测试要么正在接受 FDA 审查，要么正在积极开发中，包括肿瘤组织起源和 AmpliChip p53。所有诊断性微阵列测试都是由医生订购的，并由经过临床实验室改进修正案认证 (CLIA) 的参考实验室进行测试。最近，提供基于消费者的微阵列测试的公司已经出现。个人可以在线订购测试，服务提供商通过受密码保护的安全网站直接将结果发送给客户。Navigenics、23andMe 和 deCODE Genetics 代表了该领域的先驱公司。尽管这些基于微阵列的测试的进展令人非常鼓舞，有潜力彻底改变常见疾病的识别和治疗，但这些测试仍处于起步阶段，面临技术、临床和营销方面的挑战。在本文中，我们回顾了目前已获得 FDA 批准或正在审查的基于微阵列的测试，以及基于消费者的测试。我们还提供了微阵列测试在开发和临床应用中面临的挑战和战略解决方案的摘要。最后，我们对基于微阵列的临床应用的未来进行了简要展望。
