FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications?

The reduction in the rate of cervical cancer is one of the great success stories in public health.  The introduction of the Pap smear and human papillomavirus (HPV) testing has led to a significant reduction in the rate of cervical cancer.  However, there are still gaps in cervical cancer screening.  FDA will hold a public workshop early next year to talk about the possible use of a new measure to improve screening: self-collection of samples.

In its September 8 Federal Register notice announcing the meeting, FDA noted that “gaps in cervical cancer screening exist.”  The agency explained, “Barriers to cervical cancer screening may include limited access to such service in rural areas, socioeconomic status, etc.”  FDA is undoubtedly correct that cervical cancer screening rates can be and should be improved, and that there are non-medical barriers to increased testing.

The announcement is obviously significant for companies involved with cervical cancer testing.  The adoption of self-collection tests could expand the volume of HPV testing and Pap testing.  Moreover, this creates a potential market opportunity for companies that can make the self-collection devices.

However, the implications of the public workshop potentially go well beyond the field of cervical screening.  Many companies have wanted to pursue self-collection of diagnostic specimens by consumers for a variety of analytes and conditions.  Obtaining FDA clearance for those products has not been easy.  The upcoming workshop may shed some useful light on how companies can better position themselves to enter the market for self-collection devices for other diagnostic purposes.  At a minimum, the meeting should provide insights into issues that FDA thinks are key: “how such devices should be dispensed to end users of self-collection, proper use of the device to ensure patient safety, the collection of adequate samples for testing, the use of these test results in patient care, and the impact on the current regulatory framework.”  Those questions transcend the specific use of home-collection in cervical cancer, and apply more broadly to home-collection devices for a wide range of applications. Indeed, FDA’s consideration of OTC collection to reduce “barriers” could have implications for OTC devices generally.

Getting self-collection devices through the FDA will probably not be quick or easy, no matter what happens at the workshop. Nor is the workshop likely to lead to any change in policy by itself, and it probably won’t provide any answers at all. Still, it may illuminate some broader policy and regulatory issues for a wide range of diagnostic tests – and possibly even other devices.  That discussion could have repercussions far beyond cervical cancer screening.