New assay for symptomatic and asymptomatic individuals detects SARS-CoV-2 in saliva without extraction

February 3, 2022

SeqOnce Biosciences announces the launch of a new kit and controls for screening symptomatic and asymptomatic individuals for COVID-19 in saliva samples. The AzureSeq Direct Saliva assay does not require viral RNA extraction, saving laboratories both time and expense. The assay has Emergency Use Authorization (EUA) and is validated across a wide range of platforms for use in high-complexity CLIA laboratories.

“This addition complements SeqOnce’s broad range of COVID-19 solutions for CLIA laboratories,” stated Joseph Dunham, CSO of SeqOnce Biosciences. “Offering an American-made product in these times of supply chain turbulence is critical, and a bonus for labs is the AzureSeq Direct Saliva kit can also be used in pooling strategies.”

Use of AzureSeq Direct Saliva under EUA is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non-U.S. laboratories. Laboratories must be located in the United States and have personnel appropriately trained in RT-PCR techniques and using personal protective equipment. Laboratories must register with Yale Public School of Health to become an authorized laboratory.

For more information on AzureSeq Direct Saliva SARS-CoV-2, click here.

About SeqOnce Biosciences, Inc.

SeqOnce Biosciences is a life science genomics company developing innovative products for diagnostic technologies that address critical needs in the research and clinical markets. Learn more at