With this approval, the regulatory body of the Mexican Government, namely COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) has authorized immediate marketing of the product in Mexico
DiaCarta, a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus SARS-CoV-2 test has been approved for distribution in Mexico. In compliance with guidelines established by the World Health Organization, the Ministry of Health in Mexico through the Institute of Diagnostic and Epidemiological Reference (InDRE), similar to the US CDC, evaluated the DiaCarta SARS-CoV-2 test and granted approval of the product as it fulfilled all requirements in terms of test sensitivity, specificity and non-interference to other respiratory viruses. With this approval, the regulatory body of the Mexican Government, namely COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) has authorized immediate marketing of the product in Mexico.
DiaCarta also announced that its QuantiVirus SARS-CoV-2 RT-PCR test kit has been successfully evaluated by the Indian Council of Medical Research (ICMR). The evaluation showed 100% sensitivity and 100% specificity without any interference with other respiratory viruses and has been cleared for sale in the Indian market.
“With an urgent global need for the availability of highly sensitive and specific tests to minimize the risk of false-negative results and mitigate the ongoing transmission of the deadly virus, we are pleased that our test has met the stringent requirements of the regulatory agencies in Mexico and India and has received regulatory approvals,” said Dr. Ramanathan Vairavan, Senior Vice President at DiaCarta. He further said that “with increasing incidence of COVID-19 around the globe, there is a need for cost efficient tests that are easy to perform on commonly available qPCR platforms. At DiaCarta, we are committed to work with governmental and private institutions to increase test availability and arrest the spread of the coronavirus. In addition, the DiaCarta CLIA certified laboratory in the San Francisco Bay Area has been actively engaged to provide COVID-19 testing to support America’s Back to Work and Back to School initiatives.”
Source: Company Press Release