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OraSure Collection Device Cleared by FDA for Covid Testing

OraSure said its saliva-based collection device was included in an FDA emergency-use authorization to expand coronavirus testing.

OraSure  (OSUR) - Get OraSure Technologies, Inc. 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. 

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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.