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The point-of-care test kit, intended for professional use, delivers clinical results within 10 minutes, Beroni said.
The firm said that since March, when it provided its full-year 2020 guidance, it has seen a significant decline in testing demand as a result of the COVID-19 pandemic.
The exemptions were granted to the Philips IntelliSite Pathology Solution and Leica's Aperio ImageScope DX Viewer.
Predictive Technology said its 15-minute antibody test for COVID-19 has shown a 92 percent sensitivity and 100 percent specificity.
The test, run on the BD Max system, allows hospitals to diagnose SARS-CoV-2 on site and receive results in less than three hours.
News items for the in vitro diagnostics industry for the week of March 30, 2020.
Atomo also said it has closed an oversubscribed initial public offering and that it intends to float its shares on the Australian Securities Exchange mid-month.
Credo Diagnostics recently received the CE mark for the coronavirus test, which can provide results in 20 minutes.
Under the agreement, the companies will combine Oxgene's Adenoviral Protein Machine technology with Native Antigen Company's antigens.
The company is also participating in a study, being conducted at Hannover Medical School, investigating the genetics of susceptibility to COVID-19.