FDA clears Osmetech's Cystic Fibrosis Test

 

TIDMOMH 
 
RNS Number : 3745V 
Osmetech PLC 
09 July 2009 
 

 
 
9 July 2009 
Osmetech plc ('Osmetech' or the 'Company') 
 
 
FDA clears Osmetech's Cystic Fibrosis Genotyping Test 
 
 
Osmetech plc (OMH.L), the fast growing international molecular diagnostics 
company announces that it has received US Food & Drug Administration ('FDA') 
510(k) clearance for its eSensor  Cystic Fibrosis Genotyping Test for use on the 
eSensor  XT-8 System. This multiplex test is used for cystic fibrosis carrier 
screening for adults of reproductive age, as an aid in newborn screening for 
cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in 
newborns and children. 
 
 
This is the second FDA 510(k) cleared multiplex test the company has for use on 
the eSensor XT-8 System and follows clearance of a Warfarin Sensitivity Test. 
The Warfarin Sensitivity Test is used as an aid in the identification of 
patients at risk for increased sensitivity to the widely used blood-thinning 
drug warfarin. 
 
 
Osmetech expects further commercial progress in 2009 by expanding the eSensor 
XT-8 test menu to include an extended Warfarin Sensitivity Test panel that 
includes CYP 4F2, a CYP 2C9 Genotyping panel, a venous thrombosis panel of 
Factor V, Factor II and MTHFR and a Respiratory Virus Pathogen panel. 
James White, Chief Executive, Osmetech plc, commented: "This FDA clearance marks 
the start of the broadening of the menu of FDA cleared tests available to our 
growing base of eSensor XT-8 System customers. Our proprietary, multiplexed DNA 
eSensor technology allows for the rapid development of new tests which we plan 
to commercialise globally consistent with market demands." 
 
 
"We have been delighted with the excellent operational performance of 
our eSensor XT-8 System in the market and we will now transition our first 
generation eSensor 4800 cystic fibrosis carrier detection customers over to the 
eSensor XT-8 System, enabling them to benefit from its many advantages including 
greater ease of use and widening test menu." 
 
 
Osmetech plc                           [phone] 
James White, Chief Executive Officer 
David Sandilands, Chief Financial Officer 
 
 
Madano Partnership [phone] 
Matthew Moth, Mark Way 
 
 
Canacccord Adams Limited                                                 +44 (0) 
207 050 6500 
Robert Finlay 
Henry Fitzgerald-O'Connor 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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