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 Cell this week: Leukemia-like disease in soft-shell clams, mNET-seq method for profiling growing transcripts, and more.

While James Watson and Francis Crick are credited for discovering the structure of DNA, Rich proved their theory of a double helix structure was correct when he produced a distinct image of the structure.

Nature News reports that early users of Oxford Nanopore's hand-held MinIon are giddy about the technology and its uses. 

According to MIT Technology Review, Apple is collaborating with researchers to develop apps for consumer DNA testing.