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Bruker Gets CE Mark for Six-Plex Coronavirus PCR Test

NEW YORK – Bruker has received the CE mark for a six-plex PCR-based test for SARS-CoV-2 that can distinguish the virus that causes COVID-19 from four other endemic coronaviruses that can cause the common cold.  

Specifically, the FluoroType SARS-CoV-2 plus assay detects two genes of the SARS-CoV-2 genome as well as four other human coronaviruses from nasopharyngeal and oropharyngeal swabs in viral transport medium.

The assay kit includes the reagents to produce up to 96 results in under two hours, the firm said in a statement. It is validated for use on Bruker's GenoXtract automated nucleic acid extraction devices and extraction kits and can be used on the firm's FluoroCycler XT real-time PCR system or with other common real-time thermal cyclers.

The six-plex test showed 100 percent specificity and sensitivity in two clinical trials involving approximately ninety positive patients and more than 100 SARS-CoV-2 negative patients, Bruker said, but the firm also noted that actual clinical results may be lower as PCR tests depend on "properly timed and executed nasopharyngeal or oropharyngeal sampling." 

The combination of the GenoXtract extraction products, the FluoroCycler XT real-time thermocycler, and dedicated detection assays enables a complete solution for sample preparation and detection of SARS-CoV-2, according to Wolfgang Pusch, executive vice president of microbiology and diagnostics. And, the differentiation from other human coronaviruses that can cause a common cold reduces the risk of false-positive results due to potential cross-reactivity, he added.

"We expect that these analytical features enable a very robust second-generation PCR assay with highest sensitivity and specificity," Pusch said.

The six-plex test was developed by the firm's Bruker-Hain Diagnostics business. Bruker acquired a majority stake in Hain, an infectious disease diagnostics developer, in 2018 as part of an effort to expand its offerings beyond mass spec-based MALDI technology.

The firm has also begun offering CE-IVD marked serology antibody tests and point-of-care antigen tests in collaboration with partners.