PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, today announces its molecular testing division, Primerdesign, has entered into a clinical assay development contract with GenePOC Inc., a Canada-based company and member of the Debiopharm Group™, which specialises in the development and manufacture of molecular diagnostic devices for the detection of infectious diseases closer to the patient.
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.
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 deaths1.
Graham Mullis, Group CEO of Novacyt, commented:
“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.”
Patrice Allibert, PhD, CEO of GenePOC, commented:
“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.”
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1 WHO publication: A manual for estimating disease burden associated with seasonal influenza. Published in 2015. ISBN 978 924 154930 1
About Novacyt Group
The Novacyt Group is a rapidly growing, international diagnostics group with a growing portfolio of cancer and infectious disease products and services. Through its proprietary technology platform, NOVAprep®, and molecular platform, genesig®, Novacyt is able to provide an extensive range of oncology and infectious disease diagnostic products across an extensive international distributor network. The Group has diversified sales from diagnostic reagents used in oncology, microbiology, haematology and serology markets, and its global customers and partners include major corporates.
For more information please refer to the website: www.novacyt.com
GenePOC, a member of the Debiopharm Group™, specializes in diagnostic devices for the prevention and detection of infectious diseases. The company aims to become the market leader in rapid microbial testing. GenePOC’s revogeneTM instrument is also available in the US and EU markets with a rapidly expanding test menu.
GenePOC’s revogene™ platform is a fully automated instrument for processing clinical samples, performing homogenization, microorganism lysis, dilution, amplification and detection of target nucleic acid sequences from multiple specimens using fluorescence-based real-time PCR. Its unique design, combining a compact platform and a single-use microfluidic cartridge (PIE), enables automated nucleic acid-based testing of infectious microorganisms. During a 70 minute total run time, the revogene™ has the ability to process eight clinical samples simultaneously, detecting up to 12 genetic targets per sample. With its integrated and user friendly touch screen, the revogene™ allows medical staff to easily and efficiently perform molecular diagnostic tests.
Further information: www.genepoc-diagnostics.com