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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Apr 21, 2011


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.

The Scan

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.

Survey Sees Genetic Literacy on the Rise, Though Further Education Needed

Survey participants appear to have higher genetic familiarity, knowledge, and skills compared to 2013, though 'room for improvement' remains, an AJHG paper finds.

Study Reveals Molecular, Clinical Features in Colorectal Cancer Cases Involving Multiple Primary Tumors

Researchers compare mismatch repair, microsatellite instability, and tumor mutation burden patterns in synchronous multiple- or single primary colorectal cancers.

FarGen Phase One Sequences Exomes of Nearly 500 From Faroe Islands

The analysis in the European Journal of Human Genetics finds few rare variants and limited geographic structure among Faroese individuals.