Skip to main content
Premium Trial:

Request an Annual Quote

BD Files for FDA Approval of HPV Assay

NEW YORK (GenomeWeb) – Becton Dickinson announced today that it has submitted a pre-market approval application with the US Food and Drug Administration for its Onclarity HPV assay for human papillomavirus.

The submission is based on data collected during a two-year prospective study of more than 33,000 women, according to BD. It seeks approval to use the assay — which is designed to run on the BD Viper LT RT-PCR system — with BD SurePath specimens for the detection of 14 high-risk HPV types to determine the need for colposcopy for women 21 years and older with abnormal pap test results.

BD is also seeking approval for use of the test in women 30 years and older in conjunction with cervical cytology to adjunctively screen for high-risk HPV and individually identify virus subtypes 16, 18, and 45, as well as its use as a first-line primary cervical cancer screening test in women 25 years and old.

BD said that it intends to later seek FDA approval for the Onclarity HPV assay using genotyping beyond subtypes 16, 18, and 45.

The Scan

Germline-Targeting HIV Vaccine Shows Promise in Phase I Trial

A National Institutes of Health-led team reports in Science that a broadly neutralizing antibody HIV vaccine induced bnAb precursors in 97 percent of those given the vaccine.

Study Uncovers Genetic Mutation in Childhood Glaucoma

A study in the Journal of Clinical Investigation ties a heterozygous missense variant in thrombospondin 1 to childhood glaucoma.

Gene Co-Expression Database for Humans, Model Organisms Gets Update

GeneFriends has been updated to include gene and transcript co-expression networks based on RNA-seq data from 46,475 human and 34,322 mouse samples, a new paper in Nucleic Acids Research says.

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.