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News Story: DiaSorin Molecular Has Attained CE Marking for COVID-19 Test

Cypress, Calif. (April 1, 2020) – DiaSorin Molecular LLC announced today that it has attained CE Marking for their Simplexa™ COVID-19 Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, the virus that causes COVID-19, using nasopharyngeal swab specimens. The company also announced it had received Emergency Use Authorization (EUA) from the FDA on March 20, 2020.

DiaSorin Molecular COVID-19 Test Has Received FDA Emergency Use Authorization

Cypress, Calif. (March 20, 2020) – DiaSorin Molecular LLC announced today that it has received Emergency Use Authorization (EUA) from the FDA for their Simplexa™ COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, directly from nasopharyngeal swab specimens.

DiaSorin Molecular to Receive BARDA Funding to Develop a Rapid COVID-19 Test

Cypress, Calif. (March 13, 2020) – DiaSorin Molecular LLC announced today that it will receive federal funds from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in order to develop a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2, which causes COVID-19 disease, in response to the evolving global health emergency.

DiaSorin has Completed the Studies to Support the Launch by the End of March 2020 of A Rapid Response Molecular Diagnostic Test for the Current Novel Coronavirus (COVID-19)

Saluggia – March 10, 2020 – DiaSorin (FTSE MIB: DIA) announced today that it has completed at the Spallanzani Hospital in Rome and at the Policlinico San Matteo in Pavia, the studies necessary to support the CE marking and FDA EUA submission of an innovative molecular test for the rapid identification of the novel coronavirus COVID-19.

DiaSorin and TTP Sign Exclusive Licensing agreement for Molecular Diagnostic Point-of-Care Technology

March 2, 2020 – Saluggia, Italy and Cambridge, UK – DiaSorin (FTSE MIB: DIA) and TTP plc, a leading independent technology and product development company, today announced that they have signed an exclusive licensing and technology transfer agreement under which DiaSorin will gain access to TTP’s Puckdx™, a flexible and low-cost platform for the automation of sample-to-answer diagnostic assays.