Global distribution agreement with Bruker for COVID-19 diagnostic test
COVID-19 test receives FDA approval in the Philippines
Novacyt ( EURONEXT GROWTH: ALNOV; AIM: NCYT ), an international specialist in clinical diagnostics, announces that Primerdesign, its molecular diagnostics division, has signed a global distribution agreement for its COVID-19 test with Bruker-Hain Diagnostics, the molecular diagnostics products business unit of Bruker Corporation (Bruker).
Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test is 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.
The Company also announces that the Republic of the Philippines Department of Health Food and Drug Administration has approved the Company’s COVID-19 test for commercial use, effective immediately.
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.”
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