FDA approves new HPV assay

 

Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.

The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.

The approval for HPV testing follows a 30-month prospective, multicenter clinical trial of more than 33,000 women, comparing the assay with colposcopy and adjudicated histology results from biopsy.

The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.

dwatson@frontlinemedcom.com

 

Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.

The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.

The approval for HPV testing follows a 30-month prospective, multicenter clinical trial of more than 33,000 women, comparing the assay with colposcopy and adjudicated histology results from biopsy.

The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.

dwatson@frontlinemedcom.com

 

Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.

The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.

The approval for HPV testing follows a 30-month prospective, multicenter clinical trial of more than 33,000 women, comparing the assay with colposcopy and adjudicated histology results from biopsy.

The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.

dwatson@frontlinemedcom.com