FDA批准cobas HPV检测用于一线宫颈癌筛查

美国食品药品管理局（FDA）4月24日批准了罗氏公司的cobas HPV检测作为宫颈癌初筛一线检测方法。

据FDA称，cobas HPV检测可检测宫颈细胞样本中14种高风险HPV亚型的DNA，在识别HPV16和18的同时，可检测其他12种高风险HPV亚型。此次批准该检测用于≥25岁的女性。

FDA建议，cobas HPV检测HPV 16或HPV 18阳性的女性应接受阴道镜检查；在其他12种高风险HPV亚型中，有1种或以上HPV亚型阳性者应接受巴氏涂片检查，以确定是否需要接受阴道镜检查。

FDA还建议，当cobas PHV检测结果用于临床决定时，应同时考虑患者筛查史、风险因素以及现行专业指南。

该检测由罗氏分子诊断公司生产，2011年首次获准与巴氏涂片检查联合使用或作为涂片检查后的随访检测。此次批准后，该检测方法可用于宫颈癌初筛。

FDA体外诊断与放射健康办公室主任Alberto Gutierrez博士称，该批准令意味着女性将有更多的筛查选择。“罗氏分子诊断公司开展了设计良好的研究，这使得FDA有理由相信该检测方法用于宫颈癌初步筛查的安全性和有效性。”

尽管对可能产生困惑和超适应征使用存在某些担忧，不过，FDA微生物学医疗器械专家组3月12日投票一致支持cobas HPV检测用于宫颈癌初筛的扩大适应证批准。部分专家组成员指出，专业团体应将这一新的检测方法整合至临床实践指南中，并对医生和患者开展使用方面的培训。

该批准决定是基于ATHENA试验结果。该前瞻性研究纳入了47,208例美国女性，并随访3年。罗氏称，结果显示，与单纯细胞学检测相比，单纯HPV检测更能有效防护CNI3（3级宫颈上皮内瘤形成）和浸润性宫颈癌，HPV初筛在防护CIN3和浸润性宫颈癌方面与HPV与细胞学联合检测相当。

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The Food and Drug Administration on April 24 approved the cobas HPV test as a first-line screening test for primary cervical cancer.

The cobas HPV test uses a sample of cervical cells to detect DNA from 14 high-risk human papillomavirus types. The test, which is approved for women aged 25 years and older, identifies HPV 16 and 18. It can concurrently detect 12 other types of high-risk HPVs, according to the FDA.

The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. Those who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.

The cobas HPV test results should be used along with patient screening history and risk factors, and current professional guidelines when making clinical decisions, the FDA advised.

The test, which is manufactured by Roche Molecular Diagnostics, was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test. With the current approval, the cobas test can now be used as the primary cervical cancer screening test.

The approval means women will have more screening options, said Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health.

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer," Dr. Gutierrez said in a statement.

Despite some concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously on March 12 to support expanding the approval of the cobas HPV test to include first-line use for primary cervical cancer screening. Some panelists noted that it will be up to professional societies to integrate the new test into their practice guidelines and to educate physicians and patients about its use.

The decision to approve the test was based on the results of theATHENA trial, a prospective study of 47,208 women in the United States, and 3-year follow-up data. The results indicate that HPV testing alone provides greater protection against CIN3 (cervical intraepithelial neoplasia grade 3) and invasive cervical cancer than does cytology alone, and that primary HPV testing provides a similar level of protection against CIN3 and invasive cervical cancer as does cotesting with HPV testing and cytology, according to Roche.