Another good day here.
PharmaMar Group's GENOMICA diagnostic kits for COVID-19 coronavirus receive CE conformity marking
GENOMICA will market two products, both validated in clinical samples and with the CE conformity marking:
CLART® COVID-19 (based on GENOMICA's CLART® technology). This technology is capable of simultaneously analyzing 96 samples in less than 5 hours
qCOVID-19 (based on Real Time technology).
GENOMICA is the first Spanish company to obtain the CE marking for the diagnosis of COVID-19 coronavirus.
Madrid, March 6th, 2020.- PharmaMar (MSE:PHM) has announced that GENOMICA, the molecular diagnostics Company belonging to the PharmaMar Group, has obtained the CE conformity marking for its COVID-19 (SARS-CoV-2) coronavirus diagnostic kits. The CE conformity marking certifies that GENOMICA meets the essential requirements described in Directive 98/79/EC on in vitro diagnostic medical devices.
GENOMICA has successfully completed the tests carried out on patient samples, in collaboration with the Carlos III Health Institute, from Madrid. GENOMICA diagnostic kits are highly sensitive and specific in detecting the coronavirus COVID-19, so the virus could be detected even before the patient shows symptoms.
The kits are now available commercially, and these being compatible with the two most widely used diagnostic technologies in hospitals and healthcare centers: CLART® from GENOMICA and Real Time PCR.
CLART® technology has the capacity to simultaneously analyze 96 patient samples in less than 5 hours, making it a diagnostic option for screening of the virus within the population.
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.
With extensive experience in the detection of respiratory pathogens, the Company currently markets a diagnostic kit for the detection of 21 different viruses associated with respiratory diseases, including the three most frequently detected coronaviruses in humans (HCoV-229E, HCoV-OC43 and HCoV-NL63). Coronaviruses are an extended family of viruses that can cause the common cold, but also serious diseases such as Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS).
Due to this global health emergency, reliable diagnostic tools are needed to have a rapid response, to quickly provide adequate treatment to patients and to prevent the spread of the virus to the general population.
