BIOLYTICALS 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.
About bioLytical Laboratories
bioLytical Laboratories is a privately owned Canadian company engaged in the research, development and commercialization of rapid,
point-of-care in vitro medical diagnostics using its proprietary INSTI technology platform. Today, the company markets and
sells its signature INSTI HIV test and has a world-wide footprint of regulatory approvals including U.S. FDA approval,
Health Canada approval and CE mark from European regulators. Their product provides a highly accurate HIV test result
in as little as 60 seconds translating into a compelling value proposition for patients, healthcare professionals
and public health organizations. For more information on bioLytical Laboratories, please visit www.biolytical.com.
Mr. Robert Mackie
Source: bioLytical Laboratories
"Reproduced with permission - bioLytical Laboratories"
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