Novacyte (AIM: NCYT ) has announcement that its molecular diagnostics division, Primerdesign, has signed an agreement for certain contract manufacturing services with Yourgene Health Plc ("Yourgene") (AIM: YGEN ), an international molecular diagnostics group, and a global distribution agreement with Bruker-Hain Diagnostics, the molecular diagnostics products business unit of Bruker Corporation (“Bruker”), for its COVID-19 test.
Under the contract manufacturing agreement, Yourgene will support the company in the production COVID-19 diagnostic test utilising its state-of-the-art manufacturing facility at Citylabs in Manchester, UK. Yourgene will initially manufacture critical components of the COVID-19 test but the two Companies may seek to expand the agreement to include production of final versions of the COVID-19 test in due course. The first batches of the critical components are expected to be shipped from the Citylabs site to Primerdesign in Southampton, UK, over the next few weeks.
The Company’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test has been validated for use on Bruker-Hain Diagnostics’ GenoXtract® automated nucleic acid extraction device and associated extraction kits. It is under validation on Bruker’s new FluoroCycler® XT PCR instrument, allowing Bruker to provide a full solution from automated extraction to result. Bruker has already initiated shipments of the Primerdesign test into Spain, France, Germany and UK.
In addition, the company has announced their COVID-19 test has been approved for commercial use with immediate effect by the Republic of the Philippines Department of Health Food and Drug Administration.
Graham Mullis, Chief Executive Officer of Novacyt, commented: “As the global demand for our COVID-19 test continues to increase, we are pleased to have rapidly established a relationship with the expert team at Yourgene to further expand our manufacturing capacity. We look forward to working with Yourgene as we continue to ensure we are fully prepared to meet the demand for our test to support the global response to monitor and contain the COVID-19 pandemic.”
Lyn Rees, Chief Executive Officer of Yourgene, commented: “We are pleased to be able to utilise our high-quality manufacturing capability to support Novacyt in the production of a key diagnostic test for COVID-19. This manufacturing agreement illustrates that we have an incredibly skilled workforce and flexible manufacturing capabilities to support diagnostic test developers at critical times.”
Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, commented: “Bruker is committed to bringing innovative new diagnostics into the market and through this agreement we are joining the fight against the COVID-19 disease. In combination with our proven and validated GenoXtract (GXT) products for nucleic acid extraction, we can offer a powerful solution for preparation and detection of the SARS-CoV-2 virus. We are delighted to be partnered with Novacyt.”
Graham Mullis, Chief Executive Officer of Novacyt, added: “This agreement is another important endorsement of our COVID-19 test and is another way in which we can ensure it is distributed to a wide range of laboratories as we continue to tackle this global pandemic. In Bruker, we have found a strong international partner with a wide reach into European laboratories and look forward to building on this relationship. We are also pleased to have received approval from the FDA in the Philippines and look forward to supporting this new market.”