NEW YORK – Bruker announced Tuesday that its Bruker-Hain Diagnostics business has formed a distribution agreement with Primer Design, a Novacyt subsidiary, for the distribution of a PCR test kit to detect SARS-CoV-2, the coronavirus that causes COVID-19.
The real-time RT-PCR test is CE-IVD marked and has been validated with Bruker-Hain extraction systems. It received Emergency Use Authorization from the US Food and Drug Administration last week.
Called the Genesig real-time PCR Coronavirus (COVID-2019) CE-IVD assay, the test was developed by Primer Design. It has been validated for nasopharyngeal swabs, oropharyngeal swabs, and sputum on commonly available laboratory thermocyclers.
The test kit includes all necessary reagents to produce up to 96 results in under two hours, and has been designed for high specificity for the 2019-nCoV virus strain, Bruker said.
The kit has been validated with Bruker-Hain's GenoXtract 12 DNA/ RNA extraction system and the GenoXtract (GXT) automated nucleic acid extraction devices.
Shipments to Spain, France, Germany and the UK have already started.
"With Bruker, we have found a strong distribution partner with a microbiology and diagnostics business that has significant reach into a large number of European infectious disease laboratories," Graham Mullis, CEO of Novacyt, said in a statement. "This will help to bring our Genesig test into laboratories quickly, where its diagnostic results can help to prevent the further spreading of COVID-19."
Wolfgang Pusch, executive vice president of microbiology and diagnostics at Bruker Daltonics, said that Bruker is joining the fight against COVID-19. "In combination with our validated GenoXtract products for nucleic acid extraction, we now offer a solution for preparation and detection of the SARS-CoV-2 virus," he said, adding "We have also seen accelerated orders of our MALDI Biotyper systems from Chinese CDC laboratories, [for example] to rule in or out bacterial infections in severe respiratory disease."