REGULATORY

FDA Considering Self-Collection Sample Regulation

The U.S. Food and Drug Administration (FDA) may be considering selfcollection of samples for cervical cancer screening. The agency is seeking guidance on the evaluation of cervical sample self-collection devices for cervical cancer screening of patients, according to a Sept. 8 announcement in the Federal Register. But experts say that FDA’s consideration of selfcollection devices could have broader implications for over-the-counter testing than just for cervical cancer screening.

The announcement says the FDA will hold a public workshop entitled ”Self- Collection Devices for Pap Test" on Jan. 11, 2018. Additionally, the agency is collecting comments comment until Feb. 14, 2018. The agency says the goal of the workshop is to gather feedback about the feasibility, benefits, risks, current attitude, and impact on current standard of care of potential selfcollection of cervical cancer screening samples, as well as regulatory and validation considerations.

"The implications of the public workshop potentially go well beyond the field of cervical screening."

—Jeffry Gibbs,
Hyman, Phelps &
McNamara

Regular screening and early detection of human papillomavirus (HPV), especially high-risk strains HPV16 and 18, can prevent cervical cancer. Routine Pap testing has been heralded as a success in decreasing the incidence of cervical cancer. Yet, screening gaps exist. Known barriers to cervical cancer screening include embarrassment, limited access to testing due to geography (e.g., rural areas), and socioeconomic or insurance status.

While some surveys have shown women are interested in homebased testing, the FDA says unanswered questions remain including: how such devices should be dispensed to end users for self-collection, proper use of the device, the collection of adequate samples for testing, and the use of these test results in patient care.

The announcement is a significant development for the diagnostics industry, as adoption of self-collection tests could drive up the volume of HPV testing and Pap testing and it creates a new potential market opportunity for companies that can make the self-collection devices.

"The implications of the public workshop potentially go well beyond the field of cervical screening," writes Jeffry Gibbs, from Hyman, Phelps & McNamara, in a Sept. 21 FDA Law Blog post. "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 selfcollection devices for other diagnostic purposes."

Takeaway: The diagnostics industry should watch for suggestions coming out of the FDA workshop to understand the scientific and the regulatory considerations for potentially enabling self-collection of cervical cancer screening samples. Experts note that the comments could inform FDA action on self-collection strategies more broadly beyond just cervical cancer.

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