OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change to the OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents. The change expands the approved age range to include individuals 14 years of age and older for the OraQuick® HIV Self-Test. Previously the test was approved for use in those 17 and older.
Health Canada has granted approval to MedMira’s Multiplo Rapid TP/HIV Test, for HIV and syphilis in Canada.
The World Health Organization (WHO) has achieved a milestone by approving the addition of a packaging and shipping site for a WHO prequalified HIV rapid test for professional use. This landmark approval enables the test to be procured by governments across Africa and major international organizations, such as the Global Fund and the President’s Emergency Plan for AIDS Relief (PEPFAR).
Canadian diagnostics firm MedMira on Wednesday said it has secured US Food and Drug Administration 510(k) clearance for the HIV-2 claim that will be used in its rapid antigen tests for HIV-1/2 detection.
Roche announced that it has expanded its partnership with the US Centers for Disease Control and Prevention to improve HIV and tuberculosis prevention, testing, and treatment.
Chembio Diagnostics has obtained a CLIA waiver from the US Food and Drug Administration for its DPP HIV-Syphilis System, the firm announced on Friday.
At-home and point-of-care diagnostics company OraSure Technologies said Tuesday it secured a federal contract for up to 1 million of its OraQuick In-Home HIV Tests over five years.
Drugs developed to treat AIDS and HIV could offer hope to patients diagnosed with the most common form of primary brain tumour.
On 1 December 2021, WHO is calling on global leaders and citizens to rally to confront the inequalities that drive AIDS and to reach people who are currently not receiving essential HIV services.
Today, WHO and HRP have launched a new guideline to help countries make faster progress, more equitably, on the screening and treatment of this devastating disease.
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