Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, today announced that it has received regulatory approval for its Microgen Campylobacter spp direct-on-stool test for the Chinese market. Campylobacteriosis is caused by Campylobacter organisms and is most commonly caused by C. jejuni, a bacterium normally found in cattle, swine, and birds, where it is nonpathogenic, but the illness can also be caused by C. coli (also found in cattle, swine, and birds), C. upsaliensis (found in cats and dogs) and C. lari (present in seabirds in particular). Dr Dan Deery MD of Microgen Bioproducts, a wholly owned subsidiary of Lab21 commented: “Although Campylobacter can be effectively treated with antibiotics, the acute phase has usually passed by the time that there has been a confirmed laboratory diagnosis using traditional methods of detection. The Microgen Campylobacter assay is a rapid, easy-to-use test which can be performed quickly using a stool sample. The test can help doctors to select the right course of treatment and improve patient prognosis.” Hayden Jeffreys, Divisional Director for Diagnostic Products at Lab21, added: “It has taken the Company two years to succeed with this approval and we are delighted to be able to expand our product offering into this rapidly growing market. Campylobacter is the second product approval we have achieved in China and we expect a number of others which are actively being evaluated by the Chinese regulatory authorities, the SFDA. We believe the Chinese market is an important growth opportunity for Lab21 and our market leading infectious disease assays”.
ENDS
For further information: Lab21
Graham Mullis, CEO t: +44 1223 395450
e: graham.mullis@lab21.com
For media and investor enquiries: College Hill Nicole Yost/Gemma Howe t: +44 (0)20 7457 2020 e: lab21@collegehill.com About Lab21 Lab21 is a global leader in personalised healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations has a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: www.lab21.com |