FDA approved Roche HPV kit for primary screening of cervical cancer

Source: Biovalley 2014-4-28 Roche announced over the weekend that the FDA has approved the human papillomavirus (HPV) detection kit Cobas HPV test as a first-line and primary screening tool for primary screening of cervical cancer in women aged 25 and over This approval makes Cobas HPV test the first and only HPV test kit for primary screening of female cervical cancer in the United States Cobas HPV test is to evaluate the risk of cervical cancer based on the presence of clinically relevant DNA of the highest risk HPV (type 16 / 18) The kit can provide the genotyping information of HPV 16 / 18, and also provide the genotyping information of 12 other high-risk HPVs, and provide the summary of the test results The approval of new indications for Cobas HPV test is based on data from the landmark Athena study, which involved more than 47000 women The data shows that the vast majority of women can benefit from the primary screening of Cobas HPV test In addition, the Athena study showed that nearly one seventh of women with normal Pap smear but actually HPV16 positive and high cervical disease were missed in the cytological examination Prior to this, Cobas HPV test was approved by FDA in April 2011 for women aged 21 and over with abnormal Pap smear results, and for women aged 30 and over with normal Pap smear results, to assess the presence of high-risk HPV genotypes In the United States, 12000 women are diagnosed with cervical cancer every year This is very tragic because cervical cancer is to a large extent a preventable disease It has been recognized that HPV is the cause of almost all cervical cancer in the world Women need better screening tools, including primary HPV screening, to reduce their risk of cervical cancer HPV causes 99% of cervical cancer, while the highest risk HPV (16 / 18) accounts for 70% For decades, women have relied on cervical cytology as a tool to detect the presence of cervical cancer In June 2013, Roche submitted a supplementary application for pre marketing approval (PMA) of Cobas HPV test for primary screening of cervical cancer.