Roche said this week that the US Food and Drug Administration has cleared its Cobas 4800 HPV test for the company's Cobas 4800 system.
Cobas 4800 HPV is a qualitative in vitro test to detect HPV in patient specimens. The test uses PCR amplification of target DNA and nucleic acid hybridization to detect 14 high-risk HPV types in a single analysis to identify women who are at greatest risk for developing cervical cancer. It is the only cervical cancer screening test approved by the FDA that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing.
HPV 16 and 18 are the two highest-risk HPV genotypes and are responsible for more than 70 percent of cervical cancer cases, Roche said. In addition to identifying genotypes 16 and 18, the Cobas HPV Test simultaneously detects 12 other high-risk HPV genotypes.
Current guidelines for screening allow for either cytology alone or cytology with HPV testing to determine cervical cancer risk. HPV testing, and in particular 16 and 18 genotyping, identifies more women at risk for cervical cancer earlier than Pap cytology testing by itself. In the US, 55 million Pap smears are performed each year.
FDA's clearance was based on data from Roche's Athena study of more than 47,000 women in the US. Data from the study show that 10 percent of women age 30 and older who tested positive for HPV 16 and/or 18 by the cobas HPV Test had cervical pre-cancer, although Pap smears indicated normal results (PCR Insider, 7/8/10).
The US Food and Drug Administration has approved Gen-Probe's Aptima Trichomonas vaginalis assay for the company's automated Tigris platform, Gen-Probe said this week.
The assay is the first nucleic acid amplification test cleared specifically for Trichomonas vaginalis, the most common curable sexually transmitted infection in the US, where 7.4 million men and women are infected annually, Gen-Probe said, citing statistics from the US Centers for Disease Control and Prevention.
The company added that current screening methods for trichomonas such as culture methods are limited by sensitivity and slow turnaround times.
Gen-Probe's assay uses the same technology as the company's Aptima Combo 2 assay: target capture for the in vitro qualitative detection and differentiation of ribosomal RNA. The test can be used on endocervical or vaginal swabs collected by clinicians; urine; and specimens collected in PreservCyt solution from asymptomatic as well as symptomatic women.