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.
The Middleton, Wis.-based company added that it intends to supply reagents to molecular diagnostic test developers who need novel RNA and DNA polymerases and other necessary components.
As reported by PCR Insider last month, Lucigen has developed an isothermal amplification polymerase for use in loop-mediated isothermal amplification-based assays, and is seeking licensing or commercialization partners for the product.