New Molecular Assays Test for Human Papillomavirus

Two new molecular assays have been introduced in the United States for human papillomavirus (HPV) testing. The high-risk (HR) test is designed to detect the 14 high-risk types of HPV known to cause cervical cancer, while the 16/18 assay is a test for genotyping HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.

The US Food and Drug Administration (FDA; Rockville, MD, USA) has cleared for marketing Hologic's (Bedford, MA, USA) two assays, Cervista HPV high-risk (HR) and Cervista HPV 16/18, for HPV testing. This means that Hologic is the second firm to gain FDA clearance to sell a molecular diagnostic for the cervical cancer in the US.


The Cervista HPV HR test includes an internal control to verify adequate cellularity for testing, which should reduce the potential for false-negative results. The firm also noted that it requires a smaller specimen volume that may minimize inconclusive or indeterminate results, which may lead to fewer patients being called back for repeat testing. The HPV strains identified by the Cervista HPV-16/18 test represent the two most oncogenic and persistent types of HPV.

"We believe, while competition is increasing, the HPV marketplace is significantly large and underpenetrated, allowing for multiple players to be successful," wrote Peter Lawson, analyst at Thomas Weisel Partners (San Francisco, CA, USA), specialists in growth segments of the economy. "The US market is around 25 % penetrated, while penetration in Europe and Asia are in the single digits. The largest driver for the market could occur should the HPV test supplant the Pap as the primary screen, which could occur in smaller European countries in the near future, though widespread adoption is probably years away."

Related Links:
US Food and Drug Administration
Hologic
Thomas Weisel Partners