Molecular technologies company SML Genetree reported on Thursday the receipt of the Emergency Use Authorization (EUA) from the US FDA for the use of its Ezplex SARS-CoV-2 G Kit for the qualitative detection of RNA from SARS-CoV-2 specimens and swabs.
The company said that the specimens are to be collected by a healthcare provider using individual vials containing transport media.
In addition, the company's Ezplex SARS-CoV-2 G Kit test is authorized for use in laboratories in the US certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.
According to the company, Ezplex SARS-CoV-2 G Kit is a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from nasopharyngeal swabs, oropharyngeal swabs and sputum specimens as well as for use in pooled patient specimens containing up to five upper respiratory swab specimens. Sample pooling allows for more people to be tested quickly using fewer testing resources.
Concurrently, the company's Ezplex SARS-CoV-2 G Kit is designed to provide sensitive and accurate results by detecting two different regions of the SARS-CoV-2 virus: the RdRP and N genes. Results are available in approximately two and half hours post RNA extraction.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT