25th February 2020 Author: Paul Carton
First CE-Mark on SARS-2-CoV Assay Goes to Primerdesign
Primerdesign is the first company to receive CE-marking for its Covid-19 diagnostic assay. They were also the first European medical diagnostics company to produce a commercially available molecular detection kit specifically for SARS-2-CoV. The genesig® Coronavirus (Covid-19) 1.0 Real-Time PCR Assay by Primerdesign uses Taqman-style probe cleavage to generate a fluorescent signal in the presence of and detection for this novel coronavirus strain.
The kit, which allows the user to perform 96 tests, is intended for use on the following PCR platforms: Applied Biosystem® 7500, Bio-Rad CFX96 and the Roche® LightCycler 480 II. Nasopharyngeal swabs, oropharyngeal swabs and sputum samples can be used.
The genesig® Covid-19 Real-Time PCR Assay has been designed to detect all COVID-19 viral RNA sequences that are publicly available through the GISAID Epiflu database, which at the time of approval consisted of 87 whole genomes.
The CE-marking on this assay, which Primerdesign received 2 weeks after making their application, means that clinicians will not need to carry out a validation study on the test. Since the product was available to pre-order primer design had already received 288,000 requests for quotations with demand coming from China, the US, UK and many other countries around the world. Since initial reporting of Covid-19, the company has invested in manufacturing capacity to meet the current and potential future demand for its tests.
The company has also applied for Emergency Use Approval (EUA) from the US FDA, which would allow US labs to use the test for clinical diagnosis temporarily. The data generated from the CE-Mark approval will be used to support the application.
Date Published: 25th February 2020
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