Latest news on DiaSorin's response to COVID-19 outbreak
DiaSorin's response to COVID-19 continues through research projects that have been developed at the Saluggia and Gerenzano Centers in Italy.
In February and March, from the novel coronavirus outbreak, DiaSorin has promptly devised and developed a rapid and accurate molecular diagnostic test on our LIAISON MDX platform intended to detect all the currently known variants of the COVID-19. The test enables sample-to-answer results within less than 60 minutes compared to the 5-7 hours currently necessary to report patient results.
On April 17, DiaSorin announces that it has CE Marked the new LIAISON® SARS-CoV-2 S1/S2 IgG serological test and that it has received, on April 25, Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
The test responds to the need to identify the presence of antibodies in people who have been infected with SARS-CoV-2. With a throughput of 170 patient samples per hour, the LIAISON® XL platform can support an increase in testing capacity and the availability of diagnostic testing in order to mitigate the potential impact of this virus.
On May 12, DiaSorin announces that it has obtained approval for its LIAISON® SARS-CoV-2 S1/S2 IgG test from Health Canada, the Canadian government department responsible for federal health policy. Health Canada officials acknowledged that the DiaSorin test is the first serological test to receive authorization in the country.
On May 25, DiaSorin receives approval for the commercialization of the LIAISON® SARS-CoV-2 S1/S2 IgG test in Brazil from ANVISA, the Brazilian Health Regulatory Agency.
On June 30, DiaSorin announces that it has launched its new LIAISON® SARS-CoV-2 IgM test. The new test is now CE marked and available in the U.S. market, as part of the U.S. Food and Drug Administration’s process for ‘notification of validation and intent to submit an Emergency Use Authorization,’ outlined in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
On July 9, 2020 DiaSorin announces that its LIAISON® SARS-CoV-2 S1/S2 IgG test has been chosen by NHS England, the UK National Health Service, to assist with the completion of a National screening, tracking the impact and the circulation of the virus on the UK population.
On September 7, 2020 DiaSorin announces that it has received FDA Clearance for its Simplexa™ Flu A/B & RSV Direct Gen II kit. The molecular assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV).
On September 16, 2020 DiaSorin announces that it has attained CE Marking for the addition of saliva specimens for use with the Simplexa™ COVID-19 Direct assay. This new specimen claim enables additional flexibility for laboratories to increase capacity, overcome ongoing bottlenecks, and better manage worldwide swab and transport media shortages to detect SARS-CoV-2 RNA in patients suspected of COVID-19 infection. Saliva specimen collection is conducted using sterile cups without the need for special devices or sample extraction. The patient’s self-collection of their saliva sample in a healthcare setting is simple, easy, and non-invasive and reduces the potential risk of COVID-19 exposure for those at the forefront of patient care.
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John Gerace, President of DiaSorin Molecular
September 16 - "The addition of saliva specimens is significant and will help hospitals to minimize exposure for their staff and reduce the impact of collection device shortages"
Carlo Rosa, CEO DiaSorin
“We are constantly looking to meet the shifting needs of hospitals, and we are excited to provide a high quality test with flexible solutions that enable laboratories to accept additional samples as they continue to play a vital role in this pandemic"
DiaSorin announces the launch of its new LIAISON® SARS-COV-2 IgM test, a new fully automated serology kit available in Europe and in the U.S. to identify the immediate response to SARS-COV-2 in COVID-19 patients
The combined testing solutions for the detection of antibodies to SARS-CoV-2
Video clip for media
INTERVIEW WITH CARLO ROSA, DIASORIN GROUP CEO
Quarto Grado, Rete 4, 27 March 2020
INTERVIEW WITH CARLO ROSA, CEO OF DIASORIN GROUP
DiaSorin's response to COVID-19
CNBC Class, 19 March 2020
THE TRUMP ADMINISTRATION AWARDS DIASORIN TO DEVELOP RAPID COVID-19 TESTS FOR THE NEW CORONAVIRUS WITHIN ONE HOUR
A RAPID RESPONSE MOLECULAR DIAGNOSTIC TEST FOR THE CURRENT NOVEL CORONAVIRUS (COVID-19)
DiaSorin Group has officially announced it has completed the studies for the launch of a newly effective molecular diagnostic test for COVID-19, that has been developed by the DiaSorin Research Center in Gerenzano, near Milan.