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Genomica Coronavirus Dx Kits Garner CE Mark

NEW YORK – Genomica, a Spanish molecular diagnostics firm owned by the PharmaMar Group, has obtained CE marking for its COVID-19 (SARS-CoV2) coronavirus diagnostic kits.
The company has developed two kits: qCOVID-19, which uses real-time PCR, and CLART COVID-19, which uses the company's CLART technology, a low-density microarray-based platform that allows the detection of multiple targets in a single test. CLART has the capacity to simultaneously analyze 96 patient samples in less than five hours, making it an option for screening, the company said.
Genomica said that it has successfully completed testing on patient samples in collaboration with the Carlos III Health Institute in Madrid, demonstrating high sensitivity and specificity.
The company also said that it is currently in discussions with various health authorities and has commercial agreements for distribution of its products in more than 30 countries.