FDA允许上市帮助检测某些白血病和淋巴瘤的测试

June 29, 2017

美国食品药品监督管理局（FDA）今天批准了ClearLLab试剂（T1，T2，B1，B2，M），这是FDA批准的第一款帮助检测几种白血病和淋巴瘤的流式细胞术测试，包括慢性白血病、急性 白血病、非霍奇金淋巴瘤、骨髓瘤、骨髓增生异常综合征（MDS）和骨髓增生性肿瘤（MPN）。

FDA器械与放射健康中心体外诊断和放射健康办公室主任Alberto Gutierrez博士说。 “这是血液肿瘤学领域的一大进步，实验室和保健专业人员现在可以获得FDA验证的测试，该测试提供稳定一致的结果，以帮助诊断这些严重的癌症。”

根据国家癌症研究所，白血病是一种血液癌症，起源于未成熟血细胞（也称为白细胞），这些细胞排挤骨髓中的健康血细胞。 55岁以上的成年人最常发生白血病，但它也是15岁以下儿童最常见的癌症。 淋巴瘤是一种从淋巴细胞开始的癌症。淋巴系统是免疫系统的一部分，可帮助身体抵御感染和疾病。

ClearLLab检测用于检测血液、骨髓和淋巴结中的癌细胞，并为实验室和临床医生提供有关白血病或淋巴瘤类型的信息。 它用荧光染料标记在细胞表面上的蛋白，之后在流式细胞仪上进一步分析。

FDA通过从头开始的上市前审查途径审评ClearLLab测试的数据，该途径是一种新颖的监管途径，适用于低到中等风险、与已经合法销售的设备并不基本相当的设备。该批准基于在四个独立临床机构的279个样本上进行的比较测试性能的研究。该研究将测试结果与临床机构使用的替代检测方法进行了比较。研究结果显示，测试结果符合研究现场93.4％的最终诊断结果，正确检测到癌症存在（即癌症异常）的比率为84.2％。

随着这一批准，FDA正在建立一个称为特殊控制（special controls）的标准，其中阐明了FDA在确保测试的准确性、可靠性和临床相关性方面的期望。 这些特殊控制与一般控制相结合，可为ClearLLab试剂和帮助诊断白血病和淋巴瘤的类似试验提供合理的安全性和有效性保证。特殊控制也是适用于白血病和淋巴瘤的类似诊断测试的监督途径，带给未来开发者的负担最小。

FDA建议新测试的用户请受过训练的专业人员审查其测试结果。

这些ClearLLab试剂（T1，T2，B1，B2，M）由Beckman Coulter，Inc.公司生产。

了解详情，请阅读FDA新闻稿。谢谢！

FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas

June 29, 2017

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

“This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.”

According to the National Cancer Institute, leukemia is a cancer of the blood that originates in immature blood cells (also called leukocytes), which crowd out the healthy blood cells in the bone marrow. Leukemia occurs most often in adults older than 55 years, but it is also the most common cancer in children younger than 15 years. Lymphoma is a cancer that begins in the cells of the lymph system, a part of the immune system that helps the body fight infection and disease.

The ClearLLab test is used to detect cancerous cells in blood, bone marrow and lymph nodes, and it also provides laboratories and clinicians with information about what type of leukemia or lymphoma is present. It works by marking proteins found on the surface of cells with fluorescent dyes for further analysis on an instrument known as a flow cytometer.

The FDA reviewed data for the ClearLLab test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Its authorization was supported by a study designed to demonstrate the test’s performance, which was conducted on 279 samples at four, independent clinical sites. The study compared the test’s results to alternative detection methods used by the clinical sites. The study showed that the results of the test aligned with the study site’s final diagnosis 93.4 percent of the time and correctly detected that there was a cancer presence (i.e., cancer abnormality) 84.2 percent of the time.

Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the test’s accuracy, reliability and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for the ClearLLab Reagents and similar tests used to aid in the diagnosis of leukemias and lymphomas. The special controls also describe the least burdensome regulatory pathway for future developers of similar diagnostic tests for leukemias and lymphomas.

Users of the new test are advised that results must be reviewed by a trained professional. 

The FDA granted market authorization of ClearLLab Reagents (T1, T2, B1, B2, M) to Beckman Coulter, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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