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FDA Releases Draft Guidance for HPV IVD Tests

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued a draft guidance for industry and FDA staff covering how in vitro diagnostic devices for human papillomaviruses should be measured and handled for analytical and clinical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FDA's Center for Devices and Radiological Health released the guidance today for comment purposes, providing a set of recommendations for the types of studies of IVDs that are intended to detect and differentiate HPV strains and are used in conjunction with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.

Specifically, the guidance addresses devices for detecting HPV nucleic acid from cervical specimens, but many of the recommendations will be applicable to protein-based tests.

The failure of devices that detect and differentiate HPV strains to correctly interpret results can lead to incorrect patient management decisions in cervical cancer screening and treatment. Because cervical cancer screening is recommended for "virtually all sexually active women" and a number of them will be tested for HPV, the potential risk and harm of poor testing technology and practices could cause significant "harm to public health," said the guidance document.

False negative test results could lead to delays in diagnosis and treatment, which could allow an undetected cancer to worsen. False positive results could lead many women to have unnecessarily frequent screening and potentially invasive procedures such as colposcopy and biopsy.

In addition, CDRH said that false positive results for high-risk HPV types, such as HPV 16 or 18, could lead to "unnecessarily aggressive treatment of cervical lesions that could impair fertility," FDA said.

CDRH has proposed a number of specific draft recommendations, covering performance characteristics for analytical studies, the risks to health, detection limits, repeatability, specimen and reagent storage rules, and intended use.