An international specialist in clinical diagnostics has entered into a clinical assay development contract with a Canadian company, which specialises in the development and manufacture of molecular diagnostic devices for the detection of infectious diseases
Novacyt has announced its molecular testing division, Primerdesign, has entered into a clinical assay development contract with GenePOC, member of the Debiopharm Group.
Under the terms of the services agreement, Primerdesign will develop a triplex molecular diagnostic assay to identify influenza A, influenza B and respiratory syncytial virus A and B (RSV A and B), which will subsequently be run on GenePOC’s revogene instrument. GenePOC will seek regulatory clearance for the assay in the US through the US Food and Drug Administration (FDA) and CE-IVD marking in Europe under the In Vitro Diagnostic Directive.
Graham Mullis, Group CEO of Novacyt, said: “I am delighted that we are entering into this clinical development agreement with GenePOC, a leader in the provision of high-speed, high-quality and on-the-spot molecular diagnostic devices to healthcare practitioners. This marks our first significant business-to-business clinical development contract win in 2018 and adds further momentum to our business-to-business segment following material contract wins in China for both Primerdesign and NOVAprep.”
“GenePOC is an ideal partner given their expertise in developing accurate and cost effective molecular solutions to detect infectious diseases. GenePOC has already received US Food and Drug Administration clearance and CE marking for an assay to diagnose hospital acquired infections, as well as CE marking for a neonatal diagnostic assay. We look forward to working with GenePOC and building on this important partnership.”
The World Health Organisation (WHO) states influenza spreads around the world in a yearly outbreak. In annual influenza epidemics, 5-10% of the world’s population are affected with upper respiratory tract infections, resulting in approximately three to five million cases of severe illness and approximately 250,000 to 500,000 deaths.
Patrice Allibert, PhD, CEO of GenePOC, said: “I am pleased to enter into a partnership with Novacyt, an expert in molecular diagnostic assay development. We were impressed with Primerdesign’s ability to rapidly develop assays and track record of CE marking diagnostic tests."
"I am confident that they are the right partner to help us deliver the technically challenging multiplexed respiratory disease assay and, in combination with our near patient testing revogene platform, this will improve clinical outcomes for patients around the world.”