Good news last week for companies developing molecular tests for the diagnostic market and even better news for the patients who will benefit from having this type of information available to their Physicians. Today most women in the U.S. receive an annual pap smear to screen for atypical cells in the cervical area. The physician collects cells from the cervix using a cervical collection device and transfers them to a slide for staining and analysis under a microscope by a licensed cytologist. Some women will also receive an HPV test to determine if they have been infected with human papillomarivirus (HPV) that has been associated with cervical cancer. Pap smear results are provided to the physician who will then report back to the patient whether the results were normal or otherwise. When the results are atypical but not clearly dysplastic or "cancerous" the physician decides how to manage the patient’s care, either refer the patient for colposcopy (a method used to get a closer look at the cervix) or monitor which means wait for the next Pap smear.
The most important risk factor in the development of cervical cancer is infection with a high-risk strain of human papillomavirus. The virus cancer link works by triggering alterations in the cells of the cervix, which can lead to the development of cervical intraepithelial neoplasia, which can lead to cancer. This week FDA granted PMA approval to Hologic Inc. for their two HPV diagnostic tests, both of which are the first of it’s kind; Cervista HPV HR for detecting the 14 high risk HPV types of HPV known to cause cervical cancer and Cervista HPV 16/18 for DNA genotyping the two HPV types associated with 70% of cervical cancers in the U.S.
Both of the tests have been FDA approved for two intended uses which if adopted by physicians should improve the quality of healthcare for women in U.S. The Cervista HPV HR test has been approved for screening women with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy and for adjunctive use with cervical cytology to screen women 30 years and older for the absence/presence of high-risk HPV types. The Cervista HPV 16/18 test has also been approved for use in women 30 years and older, and in patients with ASC-US cervical cytology results, to be used adjunctively with the Cervista HPV HR test and cervical cytology to assess the presence/absence of specific high-risk HPV types.
This is great news for women who rely entirely on their physician to screen for cervical cancer and HPV infection and to recommend additional diagnostic tests when warranted. This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies who are seeking regulatory approval/clearance to bring state-of-the-art molecular diagnostic testing to the patients who needed them. Some diagnostic companies view a PMA submission as a nearly impossible regulatory hurdle. These recent approvals are evidence that it can be accomplished with a combination of good science, early and close collaboration with the FDA, and last but not least the passion and courage to make it happen.