Roche Diagnostics originally scored an approval to market its Cobas HPV diagnostic for use along with the older cervical-cancer Pap test, but a request it just filed with the FDA could give the drug maker a primary screening indication. If approval is granted, Roche said, Cobas could become the first-line diagnostic for use in screening women for cervical cancer, rather than the Pap smear currently used as part of a greater screening strategy for the disease.
Cobas is the only diagnostic that provides pooled results for high-risk genotypes, including individual results for the two highest-risk genotypes, HPV 16 and HPV 18—a point of differentiation from Qiagen’s Digene test and Hologic’s Cervista assays.
The test was approved in April 2011 to screen adults over 21 years of age with abnormal Pap test results and to co-test with Pap in older women to assess the presence or absence of high-risk HPV genotypes. It received the CE mark in the EU last November.
In a statement issued yesterday, Roche said research shows that incorporating high-risk HPV DNA testing with simultaneous detection of genotypes 16 and 18 as an initial screening test can detect more cervical disease than strategies that use Pap alone.
The National Cancer Institute estimates there are 12,200 new cases of cervical cancer in the US each year and 4,200 will die from the disease in the same time frame.
In related news, researchers found that too few doctors are following guidelines for cervical cancer and HPV screening, Healthday News reports today. In the survey of 366 US-based obstetricians-gynecologists, less than one-third said they vaccinate eligible patients against HPV. Only half follow cervical cancer prevention guidelines.
HPV screening is recommended for females ages 11-26, although current guidelines issued by the American Congress of Obstetricians and Gynecologists suggest women aged 21-29 receive a Pap smear once every two yearsand, from 30 on, once every three years if they’ve had either prior normal Pap test results or negative results on tests for HPV.
When asked by the researchers what was keeping them from vaccinating eligible patients, most doctors cited parent and patient refusals.