罗氏（Roche）3月13日宣布，FDA医疗器械顾问委员会微生物学设备专家小组一致投票建议批准该公司研发的人类乳头瘤病毒(HPV)试剂盒cobas HPV Test作为一种一线、初级筛查工具，用于25岁及以上女性宫颈癌的初级筛查。该试剂盒是基于临床相关高风险HPV DNA的存在来评估宫颈癌的风险。该小组一致认为cobas HPV Test作为一线初级筛查工具的临床利益大于其风险。

此外，专家小组还一致投票认为，cobas HPV Test用于所建议使用的适应症时安全有效。如果获批，cobas HPV Test将成为美国首个也是唯一一个用于宫颈癌一线初级筛查的HPV检测试剂盒。

该小组的积极意见是基于具有里程碑意义的ATHENA研究的积极数据。ATHENA研究涉及超过4.7万名女性，研究数据表明，绝大多数的女性能够从cobas HPV Test初级筛查中受益。事实上，ATHENA研究表明，近七分之一巴氏细胞学检查正常但实际上却是HPV 16阳性并伴有高度宫颈疾病的女性在细胞学检查中被漏掉。

在美国，每年有1.2万名女性被诊断为宫颈癌。这非常悲惨，因为宫颈癌在很大程度上是一种可以预防的疾病。目前已经公认，HPV是导致全球几乎所有宫颈癌的因素。女性需要获取更好的筛查工具，包括HPV初级筛查，以降低罹患宫颈癌的风险。HPV导致了99%的宫颈癌，而HPV基因型16和18占到了70%。几十年来，女性一直依靠细胞学检查作为检测宫颈癌存在与否的工具。

FDA将考虑该委员会的建议再决定是否批准cobas HPV Test用于宫颈癌初级筛查的一线工具。cobas HPV Test已于2011年4月获FDA批准，用于21岁及以上宫颈细胞学结果异常的女性，以及用于30岁及以上女性以评估是否存在高风险HPV基因型。罗氏于2013年6月提交了cobas HPV Test用于宫颈癌初级筛选适应症的上市前批准（PMA）补充申请。

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first line, primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States.

“Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer,” said Dr. Thomas C. Wright, Jr., Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center, NY. “I am pleased that the FDA panel recognized the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”

HPV causes more than 99 percent of cervical cancers and HPV genotypes 16 and 18 cause 70 percent of these cases worldwide. For decades, women have relied on cytology to detect evidence of disease. The ATHENA study, which included more than 47,000 women, showed that a significant number of women would benefit by using the cobas HPV Test as primary screening for cervical cancer. In fact, ATHENA demonstrated that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.

“Through technological and scientific advancement, we now have a better screening tool for cervical cancer. Women around the world deserve the best tool to know their risk and reduce their chances of developing cervical cancer,” said Roland Diggelmann, COO Division Roche Diagnostics. “We look forward to working with the FDA and medical community to support the growing understanding and awareness of the role that HPV plays in cervical disease, and the importance of the cobas HPV Test, which provides the necessary medical benefit to become the first line test in a cervical cancer screening strategy. ”
The Committee's recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV Test. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing medical devices.

About the cobas HPV Test and cobas 4800 System

Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample.

The cobas HPV Test received FDA approval in April 2011 for screening patients age 21 and older with abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes. Roche submitted their Premarket Approval (PMA) supplement for the cervical cancer primary screening indication with the FDA in June 2013. The filing includes 3-year follow-up data from the ATHENA study, Roche’s landmark U.S.-based registration trial. ATHENA enrolled more than 47,000 women who were screened for cervical disease and an impact analysis of screening algorithms was performed based on these data.

The test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas CT/NG Test (chlamydia/gonorrhea), the cobas BRAF V600 Mutation Test and the cobas EGFR Mutation Test.

About Human Papillomavirus and Cervical Cancer

Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Cancer Institute, there are more than 12,000 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually.

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