OraSure Technologies Inc

OraSure Technologies Inc (OSUR) News & Events

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OSUR News

OSUR Events

7/21 17:00

OraSure Receives FDA Approval for Ebola 2.0 Rapid Test

OraSure announced that it has received Emergency Use Authorization from the FDA for its second generation OraQuick Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Tai Forest. The OraQuick Ebola Rapid Antigen Test originally received De Novo marketing authorization from the FDA in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of Ebola virus. The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority under a contract granted in 2022.

6/11 09:00

OraSure Receives FDA Clearance for Colli-Pee Dx Urine Collection Kit

OraSure (OSUR) announced FDA clearance of its Colli-Pee Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche's (RHHBY) tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium and run on Roche's cobas 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients.

2/10 08:30

OraSure Receives Canadian License for OraQuick HIV Self-Test

OraSure Technologies announced its OraQuick HIV Self-Test has received a license from Health Canada for use in Canada. The OraQuick HIV Self-Test is a point-of-care rapid antibody test. It is Canada's first oral HIV self-test and detects antibodies for both HIV-1 and HIV-2.

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