10th March 2020 Editorial by: Genomica, S.A.U.
Spanish Biotech Company Receive CE-IVD Marking on Two Covid-19 Diagnostic Test Kits
The Spanish Biotechnology company GENOMICA SAU, who are part of the PharmaMar Group, has received CE-IVD Marking for both of its PCR-based Covid-19 assays, with one of these, the qCovid-19 kit, having 100% accuracy.
The qCovid-19 is a real-time multiplex RT-PCR test kit which amplifies two different SARS-CoV-2 genes. Based on the principle of Taqman probes, it detects the probes on the channels in FAM and VIC. The back transcription and amplification reaction of the cDNA are carried out in the same tube. This kit allows analyzing of 48 samples in a single analysis in 1h and 30 min. This kit has been validated at the Carlos III Health Institute with a panel of 80 samples with a diagnostic sensitivity and a diagnostic specificity of 100%.
CLART®COVID-19 is based on the CLART® technology patented by GENOMICA SAU. It is a multiplex RT-PCR where SARS-CoV-2 genes are amplified followed by hybridization with specific probes in low-density microarrays. Due to the automation capabilities of this system, up to 96 different patient samples can be processed at the same time in less than 5 hours. The kit has also been validated at the Carlos III Health Institute with a panel of 80 samples with a diagnostic sensitivity> 96% and a diagnostic specificity of 98%.
GENOMICA is already in contact with the different health authorities to provide these diagnostic kits given the demand generated by the health emergency due to the Covid-19 infection. In addition, GENOMICA already has commercial agreements in more than 30 countries, including China, where it can now start distributing these kits.
Date Published: 10th March 2020
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