bioLytical’s INSTI HIV Assay Receives FDA Approval for HIV-2
RICHMOND, B.C., Feb. 24, 2015 – bioLytical Laboratories Inc., a leading manufacturer of point-of-care rapid diagnostic tests, announced today that it has received U.S. Food and Drug Administration (FDA) approval of its INSTI HIV Antibody Test for use in detecting antibodies to HIV type 2 (HIV-2). With this approval, 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. Centers for Disease Control and Prevention (CDC) estimates that over 1.2 million persons aged 13 years and older are living with HIV infection in the United States, including over 168,300 (14%) who are unaware of their infection.1 With the ability to expand into more public health bodies and hospital markets, bioLytical will be able to better serve its community through more readily available HIV testing.
The Company is excited to add the HIV-2 claim to its already impressive regulatory approval credentials, including those from Health Canada and the European Union, the World Health Organization (Prequalification) and the U.S. FDA. INSTI's FDA approval also includes a "CLIA" waiver which allows the test to be administered outside of a laboratory setting by anyone who has been trained in its use - an important consideration in global ‘seek and treat’ testing initiatives. Providing HIV testing services in non-clinical venues facilitates access for individuals who may not access these services through other health care providers, those who may be testing for the first time, or those at highest risk of acquiring HIV who would benefit from repeated testing.
Mr. Robert Mackie, Executive Chairman of bioLytical Laboratories, is proud of the many accomplishments the bioLytical team has achieved as the Company surpasses yet another major milestone. “We are expanding our sales force in multiple U.S. 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 U.S. market to increase market share.”
“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. We are thrilled to have obtained the HIV-2 designation,” said Rick Galli, Chief Technical Officer of bioLytical Laboratories.