OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

OraSure Technologies Inc., a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, announced that its OMNIgene·ORAL (OM/OME-505) collection device was included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) amendment granted to 3B BlackBio Biotech, a supplier and developer of RT-PCR diagnostic assays in India. This is the seventh customer EUA that includes a collection device from the company’s DNA Genotek subsidiary.
 
This EUA amendment will allow 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the United States as well as from its upcoming New Jersey-based laboratory.

“A saliva-based collection method for COVID-19 laboratory tests is a valuable addition to our testing portfolio for helping diagnose SARS-CoV-2 infection,” said Aditi Luthra, CEO, Genophyll Enterprises. “Now, Genophyll Enterprises has access to a robust and safe biomaterial collection approach for the detection of COVID infections. This expansion of testing methods is critical to informing patient management decisions and containing the spread of COVID-19.”
 
This EUA amendment granted to 3B BlackBio Biotech includes the addition of qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens that are collected with the assistance of a healthcare provider (HCP) using the OMNIgene·ORAL (OM-505/OME-505) saliva collection device by individuals suspected of COVID-19. The 3B BlackBio Biotech SARS-CoV-2 assay, combined with OMNIgene·ORAL, facilitates the detection of nucleic acid from SARS-CoV-2 samples using highly sensitive quantitative PCR technology. A product of OraSure’s DNA Genotek subsidiary, OMNIgene·ORAL saliva collection devices are intended for use by individuals to collect and immediately stabilize saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA) at ambient temperature for transport.
 
“As the pandemic evolves, the need for testing continues to grow,” said Kathleen Weber, executive vice president, Business Unit Leader, Molecular Solutions at DNA Genotek. “The addition of OMNIgene·ORAL to 3B BlackBio Biotech’s EUA expands access to saliva-based collection to more individuals, which will result in more testing and help provide the confidence we need to help get back to living with more normalcy.”
 
“3B BlackBio Biotech aims at fulfilling the current demand of higher testing and has stepped up its production capacity for RT-PCR kit for SARS-CoV-2 detection. Our kit coupled with the Saliva Specimen Collection Device of OraSure’s DNA Genotek will make the sampling easier for the healthcare service provider (HCP) and will also reduce the patient’s discomfort,” said Dhirendra Dubey, managing director, 3B BlackBio Biotech India Limited.