Navigation Links
bioLytical's INSTI HIV Assay Receives FDA Approval for HIV-2
Date:2/24/2015

RICHMOND, BC, Feb. 24, 2015 /PRNewswire/ - 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.

(Photo: http://photos.prnewswire.com/prnh/20150224/177407)

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 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.


'/>"/>
SOURCE bioLytical Laboratories
Copyright©2015 PR Newswire.
All rights reserved

Related biology technology :

1. Professor of Art from Northern Virginia Community College Lectures at Cajal Institute
2. Lupus Research Institute Requests Strengthened NIH Funding for Biomedical Research in Debilitating Diseases like Lupus
3. The BioVoyage Institute Now Offering Hands-On Training Programs For Biotechnology Products & Applications
4. Philanthropist John Moores Gives $2 Million to The Scripps Research Institute to Develop River Blindness Field Test
5. The BioVoyage Institute is seeking the help of corporations, organizations, institutions, communities and individuals to help with bioscience and biotechnology education
6. Cellular Dynamics and Coriell Institute for Medical Research Awarded Multi-Million Dollar Grants from California Institute for Regenerative Medicine to Manufacture and Bank Stem Cell Lines
7. Regenerative Medicine Company, Eqalix, Announces Grant from Nanotechnology Institute in Philadelphia, Pennsylvania
8. CellHealth Institute Launches with Support from Influential Investors
9. California Healthcare Institute Appoints Associate Director, Federal Government Relations and Programs
10. Blanchette Rockefeller Neurosciences Institute Partners with Neurotrope BioScience to Advance New Alzheimers Disease Discoveries
11. Venter Institute-Led Team Recovers and Sequences Genome of Periodontal Pathogen from Biofilm in Hospital Sink using Single-Cell Genomics
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... 11, 2017 , ... The CRISPR-Cas9 system has ... and avoiding the use of exogenous expression plasmids. The simplicity of programming this ... gain-of-function studies. , This complement to loss-of-function studies, such as with RNAi ...
(Date:10/11/2017)... ROTTERDAM, the Netherlands and LAGUNA HILLS, ... that The Institute of Cancer Research, London ... will use MMprofiler™ with SKY92, SkylineDx,s prognostic tool to risk-stratify ... high-risk trial known as MUK nine . The University ... this trial, which is partly funded by Myeloma UK, and ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... advancing targeted antibody-drug conjugate (ADC) therapeutics, today confirmed licensing rights that give ... Liposomal Nanoparticle), a technology developed in collaboration with Children’s Hospital Los Angeles ...
(Date:10/10/2017)... SANTA BARBARA, CALIFORNIA (PRWEB) , ... October 10, ... ... risk management, technological innovation and business process optimization firm for the life sciences ... the BoxWorks conference in San Francisco. , The presentation, “Automating GxP ...
Breaking Biology Technology:
(Date:4/13/2017)... 13, 2017 According to a new market research ... Analytics, Identity Administration, and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and ... is expected to grow from USD 14.30 Billion in 2017 to USD ... 17.3%. ... MarketsandMarkets Logo ...
(Date:4/6/2017)... LONDON , April 6, 2017 ... Control, RFID, ANPR, Document Readers, by End-Use (Transportation & ... Energy Facility, Oil, Gas & Fossil Generation Facility, Nuclear ... Healthcare, Educational, Other) Are you looking for ... Authentication sector? ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
Breaking Biology News(10 mins):