Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Gen-Probe HPV Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Gen-Probe's Aptima HPV assay, a molecular test to detect high-risk strains of human papillomavirus.

The test runs on the firm's fully automated, high-throughput Tigris instrument system. It detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Gen-Probe added that the Aptima HPV assay, unlike other FDA-cleared tests detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"FDA approval represents a major milestone for the company, since developing the Aptima HPV assay was the largest and most complex diagnostic R&D program we have ever completed," Gen-Probe President and CEO Carl Hull said in a statement.

The test is approved for women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance and to screen women age 30 and older as an adjunct to Pap testing.

Gen-Probe said that it expects to launch the Aptima HPV test in the US within the next two weeks. It anticipates recording its first revenues from the assay in the US during the first quarter of 2012.

The Scan

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.