Sisson Bridgette A, Uvalic Jasmina, Kelly Kevin, Selvam Pavalan, Hesse Andrew N, Ananda Guruprasad, Chandok Harshpreet, Bergeron Daniel, Holinka Lauren, Reddi Honey V
The Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.
Biomark Insights. 2019 Feb 1;14:1177271919826545. doi: 10.1177/1177271919826545. eCollection 2019.
The standard of care in oncology has been genomic profiling of tumor tissue biopsies for the treatment and management of disease, which can prove to be quite challenging in terms of cost, invasiveness of procedure, and potential risk for the patient. As the number of available drugs in oncology continues to increase, so too does the demand for technologies and testing applications that can identify genomic alterations targetable by these new therapies. Liquid biopsies that use a blood draw from the diseased patient may offset the many disadvantages of the invasive procedure. However, as with any new technology or finding in the clinical field, the clinical utility of an analytical test such as that of the liquid biopsy has to be established. Here, we review the clinical testing space for liquid biopsy offerings and elucidate the technical and regulatory considerations to develop such an assay, using our recently validated PlasmaMonitor test.
肿瘤学的护理标准一直是对肿瘤组织活检进行基因组分析，以用于疾病的治疗和管理，但这在成本、操作的侵入性以及对患者的潜在风险方面可能极具挑战性。随着肿瘤学中可用药物数量的持续增加，对能够识别这些新疗法可靶向的基因组改变的技术和检测应用的需求也在增加。使用患病患者血液样本的液体活检可能会弥补侵入性操作的诸多缺点。然而，与临床领域的任何新技术或发现一样，诸如液体活检之类的分析测试的临床实用性必须得到确立。在此，我们回顾了液体活检产品的临床检测领域，并利用我们最近验证的血浆监测测试阐明了开发此类检测方法的技术和监管考量。
