NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued a draft guidance for industry and FDA staff covering how in vitro diagnostic devices for human papillomaviruses should be measured and handled for analytical and clinical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FDA's Center for Devices and Radiological Health released the guidance today for comment purposes, providing a set of recommendations for the types of studies of IVDs that are intended to detect and differentiate HPV strains and are used in conjunction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

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In PLOS this week: gene fusion in premature ovarian failure, population patterns in the Franciscana dolphin, and more.

A National Science Foundation-funded project aims to give researchers access to a network many times faster than the Internet.

Bioethicists weigh the idea of charging patients to take part in clinical research, coming down against the approach.

Cornell's Christopher Mason and his colleagues correct their New York City microbiome study to emphasize "the difference between matching fragments of DNA from a species and a pathogen."

Sep
17
Sponsored by
Omicia

This online seminar will provide examples of how commercial and hospital-affiliated clinical labs are successfully developing and deploying high-throughput next-generation sequencing-based testing services for genetic diseases. 

Oct
15
Sponsored by
Parabase

This webinar will discuss the benefits of a rapid targeted next-generation sequencing (TNGS) panel, using dried blood spots, for second-tier newborn metabolic and hearing loss screening and its immediate utility for high-risk diagnostic testing in the neonatal intensive care unit.