OraSure (OSUR) - Get Report, the maker of oral tests for HIV and Ebola, received emergency-use authorization from the Food and Drug Administration for its specimen-collection device to be used in a developing PCR test to detect coronavirus.
The Ottawa company's device is part of 3B BlackBio Biotech's covid-19 test. 3B BlackBio, Bhopal, India, provides molecular-testing products and services.
OraSure's Omnigel saliva-collection device was part of an emergency-use authorization the FDA granted to the 3B BlackBio covid test.
PCR refers to a lab technique called polymerase chain reaction.
The FDA clearance will enable 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva-based covid-19 testing across the U.S.
More than 13.2 million coronavirus infections have been confirmed in the U.S. and 322,851 people have died from the disease, John Hopkins data showed.
“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, chief executive at Genophyll Enterprises, in a statement.
Genophyll now 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," she added.
"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," said Dhirendra Dubey, managing director at 3B BlackBio Biotech India Ltd.
Shares of OraSure traded on Nasdaq at last check were 1.1% higher at $11.90. They have more than doubled off their 52-week low of $5.23, set in late March. They touched a 52-week high $19.75 in early August.