Sienna Registers CE Marked IVD Product in EU
12-Dec-2016 Following on from their recent registration with the FDA in the United States, Sienna has now registered their CE-marked in-vitro diagnostic (IVD) medical device (to detect the presence of the hTERT component of telomerase) with European regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA).
The registration extends to all countries within the European Union (EU). Sienna is working to secure distribution partner agreements throughout the EU, with HistoCyte Laboratories and Biosystems Switzerland already appointed for the United Kingdom and Switzerland respectively.
Sienna’s Chief Operating Officer, Matthew Hoskin said “This IVD registration, along with the recent FDA listing, means we now have access to the two biggest markets in the world – the USA and EU. With all countries in the EU subject to a single regulatory process, this was a high priority for Sienna as it opens a large market with a single registration. Additional regulatory filings will follow for countries outside of the USA and EU.”