NovaSit: UK approval

NovaSight announced that PROmate COVID-19 1G (q32) real-time testing has been approved in the UK under the provisions of the UK Health Protection Agency Medical Devices Regulations 2021 (Acceptance of Testing Equipment for Coronavirus). The PROmate COVID-19 1G test, for use on Novasit’s q32 instrument, is the company’s second direct PCR test and the third product to be added to the CTDA’s Register of Approved Products.

The test is designed to detect a SARS-CoV-2 target gene in ORF1ab and, like all of the company’s direct PCR products, does not require complex, manual or automated extraction solutions, which dramatically increases the risk of laboratory damage. Improves workflow and reduces costs. The test was previously on the CTDA’s provisional protocol product list, which may continue to be sold in the UK while validation is underway. As previously announced, Novasit’s Promate COVID-19 1G test, used on the company’s q16 instrument (currently on the tentative protocol list), continues to be supplied to the NHS under the National Microbiology Program (National Microbiology Framework). Is.

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