Canada-based point-of-care rapid diagnostic tests manufacturer bioLytical Laboratories has obtained approval from the US Food and Drug Administration (FDA) for its INSTI HIV Antibody Test to detect antibodies to HIV type 2 (HIV-2).
According to the company, the INSTI HIV-1/2 Antibody Test is available for use in detecting HIV-1 and HIV-2 antibodies in as little as 60 seconds, with this approval.
bioLytical Laboratories executive chairman Robert Mackie said: "We are expanding our sales force in multiple US markets to support our revenue growth model and to continue to provide best in class service to our customers.
"The FDA approved and CLIA waived INSTI HIV-1/2 test will allow bioLytical to further successfully penetrate the US market to increase market share."
The FDA approval also comprises CLIA waiver, which allows the test to be administered outside of a laboratory setting by anyone who has been trained in its use.
The test already received regulatory approval from Health Canada and the European Union, as well as the World Health Organization (prequalification).
bioLytical Laboratories chief technical officer Rick Galli said: "INSTI was developed for the detection of antibodies to both HIV types and so the FDA approved HIV-2 claim will allow bioLytical to expand its markets further in the United States as some health departments require it for their testing programs."
As per the Centers for Disease Control and Prevention (CDC), around 1.2 million persons aged 13 years and older found to have HIV infection in the US, including over 168,300 (14%) who are unaware of their infection.
Image: INSTI HIV Antibody Test has received FDA approval to detect antibodies to HIV type 2. Photo: courtesy of bioLytical Laboratories Inc.