PerkinElmer, a diagnostics and imaging company, has received CE Mark approval in the EU for its PKamp™ Respiratory SARS-CoV-2 RT-PCR panel. The panel allows for the detection of SARS-CoV-2 and other influenza viruses in a single test. It is currently under review by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
Ginkgo Bioworks has secured supply to the SD Biosensor rapid antigen test. The company will distribute the test through its Concentric Covid-19 testing service in international markets where the test is approved. Ginkgo aims to acquire and distribute up to 50 million tests.
Rosti Group, a contract manufacturer, has formed a collaboration with Global Molecular Diagnostics to produce a Covid-19 saliva test capable of delivering accurate results within 15 minutes. The test will enable fast and on-site detection of SARS-CoV-2 virus even by non-medical personnel.
Ortho Clinical Diagnostics has received CE Mark approval for its VITROS® SARS-CoV-2 antigen tes. The test is suitable for mass testing and deliver results with a specificity of 99.2%. Ortho has also submitted an EUA application for the test with the FDA.
Helix, a genomics company, has received expanded EUA from the FDA for its HelixⓇ Covid-19 test, which is indicated for testing asymptomatic individuals. The expanded approval enables individuals to self-collect samples without the need for supervision by healthcare professionals.