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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.
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.
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.
OraSure Confirms Altai Capital Nominates Board Candidates
OraSure Technologies confirmed that Altai Capital has nominated two candidates, including the fund's founder Rishi Bajaj, to stand for election to the company's board at its 2026 Annual Meeting of Stockholders, stating: "As previously announced, OraSure's Board has engaged extensively with Altai Capital. The Board interviewed Mr. Bajaj for potential service on the Board and ultimately decided to appoint an alternative candidate to serve as a director at OraSure. Since that time, Altai has not accepted the Board's offers to make certain of its directors available to engage further. OraSure maintains a strong, independent, and engaged Board. We continually assess our Board composition, and as a result our Board has undergone significant refreshment, bringing in industry perspectives and executive-level experience to provide oversight as management drives growth and value creation... The Nominating and Corporate Governance Committee and OraSure's Board will review Altai's nominations, and the Board will present its recommendation in the Company's definitive proxy statement to be filed with the Securities and Exchange Commission and mailed to stockholders eligible to vote at the Company's 2026 Annual Meeting of Stockholders, which has not yet been scheduled. OraSure shareholders are not required to take any action at this time."
Altai Nominates Two Candidates to OraSure Board
Altai Capital Management, one of the largest shareholders and beneficial owners of approximately 5.2% of the outstanding common stock of OraSure Technologies, announced that it has nominated two candidates, John Bertrand, co-founder of Digital Diagnostics, and Rishi Bajaj, president and CIO of Altai, for election to the OraSure board of directors at the 2026 annual meeting of stockholders.
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