Novacyt Group

The Novacyt Group is a diagnostics company with products and services in cancer and infectious disease areas. The company engages in product development, commercialisation, contract design and manufacturing. Novacyte sells diagnostics products used in liquid based cytology (LBC), oncology, microbiology, haematology and serology. Divisions of the company include Microgen Bioproducts, which manufactures and distributes microbiology diagnostic products for clinical and food laboratories; LAB 21 Healthcare; which manufactures and supplies reagents and tests for IVD and blood grouping; Primer Design is their molecular diagnostics division which provides custom quantitative PCR (qPCR, also known as real time PCR, RT-PCR) assay development services.

Primerdesign developed a COVID-19 diagnostic test and in March, 2020 announced that it had increased manufacturing capacity to support production of 2 million COVID-19 tests per month. Novacyt is seeking FDA. Emergency Use Approval (EUA). A favourable performance assessment by Public Health England (PHE) has been reported. The test is part of the Genesig product line and is a real time PCR (RT-PCR) test that is CE-IVD marked for in vitro diagnostics in Europe.