This article has been updated to clarify that Roche's HPV assay is the only one on the market with an FDA-approved primary screening indication, and not the only FDA-approved HPV test on the market.
NEW YORK (GenomeWeb) – The US Preventative Services Task Force has issued draft recommendations proposing that women in their 20s be screened for cervical cancer every three years with cervical cytology alone.
As part of an effort to update 2012 guidelines, the group is also proposing that women between the ages of 30 and 65 be screened with cervical cytology every three years or receive testing for high-risk human papillomavirus every five years. Previously, the USPSTF had recommended that women 21 to 65 years old receive pap smears every three years or women 30 to 65 years receive both pap smears and HPV testing every five years.
In a note to investors, Cowen and Company analyst Doug Schenkel pointed out that the earlier recommendations, which extended the screening interval to five years if both pap smears and HPV testing were performed, "led to a notable decline in cytology revenue" for Hologic and Becton Dickinson, two companies that provide pap tests.
"With co-testing eliminated from the updated recommendation, both Hologic and Becton Dickinson could face an incremental revenue headwind in the US," Schenkel wrote. "If the draft recommendation statement is implemented, we believe the liquid cytology market will contract though it is currently difficult to estimate by how much." According to the analyst's modeling, Becton Dickinson generates less than $250 million in annual SurePath revenues in the US, while Hologic generates between $300 million and $350 million with ThinPrep.
Meanwhile, Hologic and Roche are leaders in the HPV testing space. Qiagen is another major player, drawing between $20 million to $25 million in US revenues from HPV testing, Schenkel estimated. If they're finalized, the draft recommendations could positively benefit Roche, he wrote, since it has the only assay with an FDA-approved primary screening indication, "though the impact to total Roche revenue and the stock is immaterial."