Cambridge, UK, September 16 - Lab21 Limited, the Cambridge, UK-based specialist in personalised medicine and infectious disease test manufacture is pleased to announce new developments in its Products Division. The new developments include its first FDA approval for the US market, the introduction of a new infectious disease screening diagnostic assay and further expansion of sales into new territories,
Lab21 has expanded the availability of its market leading blood bank screening range of diagnostic assays, having recently secured 510(k) clearance in the US for its Syphilis Treponema Pallidum Haemagglutination (TPHA) Assay, which is formatted to run on the Beckman Coulter PK7200 platform. This is the first of a number of FDA approvals that will be sought as it expands its distribution presence in the world’s largest diagnostic market.
The company also announces today that it has just launched a new CE marked cytomegalovirus Haemagglutination (CMV HA) assay, which has been formatted to run on both the Beckman Coulter PK7200 and 7300 platforms where the liquid stable reagents provide a significant ease of use advantage.
Lab21 has also recently expanded its global sales, into new territories in the Asia-Pacific region through the renewal and extension of a partnership with Alere.
Hayden Jeffreys, Divisional Director, Products at Lab21 commented: “Lab21 continues to grow, having achieved a number of important milestones this year. We are pleased to see a number of key centres in Europe performing validation studies for CMV HA prior to adoption as a routine service further strengthening our position as reagent provider in this market. Coupled with the expansion into new territories and products this means Lab21 is in a strong position for future growth.”
Graham Mullis, CEO of Lab21, added: “These achievements underline our commitment to supporting blood banks worldwide by providing high quality reagents. Lab21 is committed to global expansion, and we are very pleased to continue to be able to expand our operations in the US and Australia.”
For further information: Lab21 Graham Mullis, CEO Hayden Jeffreys, Divisional Director Products Dr Berwyn Clarke, CSDO t: +44 (0)1223 395461 e: graham.mullis@lab-21.com hayden.jeffreys@lab21.com berwyn.clarke@lab21.com
For media and investor enquiries: College Hill Tony Stephenson/Nicole Yost t: +44 (0)20 7866 7864 m: +44 (0)7989 855113 e: tony.stephenson@collegehill.com
About Lab21
Lab21 is a global provider of state-of-the-art diagnostic products and services, supporting blood bank screening, medical diagnostics and drug discovery. Its customers include international healthcare providers, pharmaceutical and biotechnology companies.
The product division of the Company manufactures immunodiagnostic kits and reagents that are distributed into 110 international countries and is focused on infectious diseases for the blood-banking market.
The service division has a growing test portfolio providing companion diagnostics and high technology molecular assays for the growing integration of personalised medicine into healthcare. These services are currently in infectious diseases, oncology and pharmacogenetics areas with emerging interests in cardiovascular and metabolic disease.
Lab21’s clinical reference laboratory and corporate office is based in Cambridge and has additional UK sites in Newmarket, Bridport, Liverpool and Ipswich. It also has operations in South Carolina, USA. The Company’s investors include Merlin Biosciences, Nexus Medical Partners, Medicis Capital, Rowan Dartington and Kreos Capital. Website: www.lab21.com
About CMV
CMV is commonly found in the population, generally causing mild illnesses with complete recovery. However, it does have the capability of establishing latent infections lasting many years and can cause significant health problems in immunosuppressed people such as those with HIV infection or in transplant settings. Because blood from infected people can transmit the virus via transfusion it is important to exclude blood donations which contain CMV antibodies since these may indicate a high risk of transmitting the infection
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