NEW YORK (GenomeWeb News) – Lucigen said on Tuesday that it has received ISO 13485 certification, achieving a major step required to submit a diagnostic test to the US Food and Drug Administration.

The ISO 13485 standard covers medical device and diagnostic product development and manufacturing, and certification was provided by the British Standards Institution-USA. Lucigen said that it plans to enter clinical trials in late 2014 and to release its first molecular diagnostic test in 2015.

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 PNAS this week: Akt3 amplification in glioma progression, Tibetan Plateau frog genome, and more.

The US Supreme Court has declined to review a decision involving the use of "inadvertently shed" DNA in a police investigation and subsequent conviction.

A panel at the New York Times discusses anonymity and privacy of users of 23andMe's services when access to its database is offered for research.

National Institutes of Health Director Francis Collins appears before a House subcommittee to discuss his agency's budget request.