Osmetech plc Receives 510(k) Clearance


 

TIDMOMH 
 
RNS Number : 7713K 
Osmetech PLC 
26 April 2010 
 

 
                          Osmetech Plc (the "Company") 
Osmetech plc Receives 510(k) Clearance for the eSensor  Thrombophilia Risk Test 
Osmetech Plc (AIM:OMH) today announced that the US Food and Drug Administration 
(FDA) has cleared the eSensor  Thrombophilia Risk Test (TRT), a multiplexed 
molecular diagnostic test for four genetic markers associated with thrombosis. 
The panel includes Factor V Leiden, Factor II Prothrombin, MTHFR 677 and MTHFR 
1298 in a single test panel. 
Thrombophilia disorders affect roughly 1 in 1,000 individuals, and genetic 
testing has become an accepted method of assessing an individual's inherited 
risk for thrombosis and other related cardiovascular events. 
"The FDA clearance of our Thrombophilia Risk Test marks a significant milestone 
in the development of our test menu and further demonstrates the value of our 
proprietary eSensor  electronic DNA detection technology," said Faiz Kayyem, 
President and CEO of Osmetech, plc. "We believe that Osmetech is the first 
company to have achieved FDA clearance for all four thrombophilia related 
genetic markers." 
The eSensor  Thrombophilia Risk Test is for use on the Company's XT-8 system, a 
versatile DNA detection platform for hospital and reference laboratories. TRT 
can be configured to report out single genetic mutation results or various 
combinations including a Factor V/Factor II only result and the full 
thrombophilia panel of all four genetic mutations. The eSensor  Thrombophilia 
Risk Test is the third product cleared by the FDA for use on the XT-8 system and 
complements existing FDA cleared products for Cystic Fibrosis and Warfarin 
Sensitivity. 
 
 
Contacts 
Osmetech plc 
 Steven Kemper, Chief Financial Officer 
 +1 
626-463-2004 
 Jon Faiz Kayyem, Chief Executive Officer 
 +1 
626-463-2000 
 or 
 Canaccord Adams Limited 
 (Nominated 
Advisor) 
 Robert Finlay 
 020 7050 6500 
 Henry 
Fitzgerald-O'Connor 
 020 7050 6500 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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