Hologic’s Aptima HPV 16 18/45 genotype assay obtains FDA approval

7 November 2013 (Last Updated November 7th, 2013 18:30)

Diagnostic and medical imaging systems provider Hologic has obtained the US Food and Drug Administration (FDA) approval for its Aptima HPV 16 18/45 genotype assay, which can be used on a completely automated Panther system.

Diagnostic and medical imaging systems provider Hologic has obtained the US Food and Drug Administration (FDA) approval for its Aptima HPV 16 18/45 genotype assay, which can be used on a completely automated Panther system.

It is the first test of its kind to receive the FDA approval for genotyping human papillomavirus (HPV) types 16, 18 and/or 45.

The Aptima HPV 16 18/45 genotype assay uses Hologic's ThinPrep liquid cytology specimens and is intended to be tested from the same sample that has already received Aptima HPV assay positive results.

According to the company, the recent data shows an increase of approximately 32% in prevalence of adenocarcinoma cases since 1970, while there is a fall in the incidence cervical cancer in the same time frame.

"The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu further extends the capability of low to high-volume laboratories to run multiple tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform."

Detection of these HPV types as part of reflex testing may help clinicians identify up to 94% of all cervical adenocarcinomas.

The data indicates HPV genotype 45 as the third most common HPV genotype in invasive cancer, which is identified in only 0.4% of women with normal cytology.

The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.

According to the studies, the HPV types 16, 18 and 45 are more likely to be integrated into the human genome than are the other HPV types, and tumours with these genotypes may present earlier.

Hologic Group vice-president diagnostics Dr Rohan Hastie said: "The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu further extends the capability of low to high-volume laboratories to run multiple tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform."

The Aptima HPV 16 18/45 genotype assay has secured approval to screen women 21 years and older showing atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, which will help in determining whether colposcopy is required.

It can also be used along with cervical cytology in order to find out high-risk HPV genotypes 16, 18 and/or 45in women 30 years and older.

The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received the FDA approval on the Hologic high-throughput Tigris system in October 2012.

According to GlobalData estimates, the US tumour markers market was valued at $489m in 2012 and is expected to grow at a CAGR of 6.6% to reach $765m by 2019.