Sedia Biosciences Receives WHO Pre-Qualification for its Asanté® HIV-1/2 Oral Fluid Test

Original from: Sedia Biosciences Corporation

Sedia Biosciences Corporation, a leading developer of innovative diagnostic tests for infectious diseases, today announced that its Asanté® HIV-1/2 Oral Fluid Test has received Pre-Qualification (PQ) status from the World Health Organization (WHO). This significant achievement enables global procurement and widespread use of this rapid diagnostic test.

The Asanté® HIV-1/2 Oral Fluid Test is a single-use, qualitative immunoassay designed for the rapid detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid specimens. It is intended for use by medical professionals at the point-of-care as a non-invasive, simple, and rapid aid in the diagnosis of HIV infection in resource constrained settings.

Enhancing Global Access and Convenience

WHO Pre-Qualification signifies that the Asanté® test meets the organization’s stringent standards for quality, safety, efficacy, and performance, making it eligible for use and purchase by UN agencies (such as UNAIDS, UNICEF, and UNDP) and other major global procurement organizations for the detection and diagnosis of HIV infections.

“Receiving WHO Pre-Qualification is a testament to the quality and reliability of our Asanté®HIV-1/2 Oral Fluid Test,” said Roger Gale, CEO and President of Sedia Biosciences. “This approval is a game-changer for expanding global HIV testing efforts. The non-invasive nature of oral fluid testing, combined with its high accuracy and ease of use, addresses critical barriers to testing in many regions, moving us closer to achieving the global goal of eliminating HIV as a public health threat.”

Source: Sedia Biosciences Receives WHO Pre-Qualification for its Asanté® HIV-1/2 Oral Fluid Test