FDA Releases Draft Guidance for HPV IVD Tests | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued a draft guidance for industry and FDA staff covering how in vitro diagnostic devices for human papillomaviruses should be measured and handled for analytical and clinical performance.

FDA's Center for Devices and Radiological Health released the guidance today for comment purposes, providing a set of recommendations for the types of studies of IVDs that are intended to detect and differentiate HPV strains and are used in conjunction with cervical cancer screening.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In PLOS this week: genetic study of breast cancer in Egyptian families, mutations linked to cleft lip and palate, and more.

Council Bluffs, Iowa, schools are encouraging more girls to pursue STEM courses, according to the Associated Press.

Because of new open-access requirements, Gates Foundation-funded researchers can't publish in some top journals, Nature News reports.

In Science this week: deletion of one microRNA allows pluripotent stem cells to form embryonic and non-embryonic lineages, and more.