Alere receives FDA Approval for Alere Determine™ HIV-1/2 Ag/Ab Combo
WALTHAM, Mass., Aug. 9, 2013
WALTHAM, Mass., Aug. 9, 2013 /PRNewswire/ --Alere Inc. (NYSE: ALR), a global
leader in enabling individuals to take charge of their health at home through
the merger of rapid diagnostics and health information, announced today that
it has received U.S. Food and Drug Administration (FDA) approval of its
pre-market application (PMA) to market Alere Determine™ HIV 1/2 Ag/Ab Combo in
the United States for the detection of HIV-1 p24 antigen and antibodies to
HIV-1/HIV-2. The FDA approval allows Alere to market Alere Determine™ HIV 1/2
Ag/Ab Combo as a CLIA (Clinical Laboratory Improvement Amendments) moderately
complex medical device.
Alere Determine™ HIV-1/2 Ag/Ab Combo is the first and only FDA-approved rapid
point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24
antigen, which can appear days after infection and prior to^, HIV-1/2
According to the Centers of Disease Control and Prevention (CDC), there are
1.4 million Americans living with HIV, and approximately 207,000 (18%) whose
infections have not been diagnosed.^ In 2010, the CDC estimated that there
were 47,500 newly infected people with the virus in the United States,
indicating that HIV remains a serious health problem.^ HIV testing is
essential for healthcare and social services to improve the quality of life
and survival for persons who have HIV. Individuals who are acutely infected
with HIV, which is defined as the interval between the appearance of HIV RNA
in plasma and the detection of HIV-1 specific antibodies, contribute
disproportionately to HIV transmission.^ With the use of the Alere
Determine™ HIV 1/2 Ag/Ab Combo, HIV can be detected earlier than second and
third generation antibody-only tests.
Avi Pelossof, Alere Global President of Infectious Disease, said, "We are
pleased that the FDA has issued the approval for Alere Determine™ HIV 1/2
Ag/Ab Combo. Our next step is to complete the CLIA waiver trials with the
intention to submit the data in late 2013 or early 2014."
Pelossof added, "The Alere Determine™ Combo can help to identify additional
cases that would not be detected using second and third generation
antibody-only tests.^ We anticipate Alere Determine™ Combo to play a
critical role in the U.S. to help identify individuals with HIV and to help
break the infection cycle."
About Alere Inc.
By developing new capabilities in near-patient diagnosis, monitoring and
health management, Alere enables individuals to take charge of improving their
health and quality of life at home. Alere's global leading products and
services, as well as its new product development efforts, focus on cardiology,
infectious disease, toxicology and diabetes. Alere is headquartered in
Waltham, Massachusetts. For additional information on Alere, please visit
^ Gurtler L, Muhlbacher A, Michl U, Hofmann H, Paggi GG, Bossi V,
Thorstensson R, G-Villaescusa R, Eiras A, Hernandez JM, Melchior W, Donie F,
Weber B. Reduction of the diagnostic window with a new combined p24 antigen
and human immunodeficiency virus antibody screen assay. J Virol Methods. 1998
^ Burst S, Duttmann H, Feldner J, Gurtler L, Thorstensson R, Simon F.
Shortening of the diagnostic window with a new combined HIV p24 antigen and
antibody HIV1/2/O screening test. J Virol Methods. 2000 Nov;90(2):153-65
^ Centers for Disease Control and Prevention. Monitoring selected national
HIV prevention and care objectives by using HIV surveillance data—United
States and 6 U.S. dependent areas—2010. HIV Surveillance Supplemental Report
2012;17(No. 3, part A).
http://www.cdc.gov/hiv/topics/surveillance/resources/reports/. Published June
^ Centers for Disease Control and Prevention. Estimated HIV incidence among
adults and adolescents in the United States, 2007–2010. HIV Surveillance
Supplemental Report 2012;17(No. 4).
Published December 2012.
^ Pilcher CD, Tien HC, Eron JJ, et al. Brief but efficient: acute HIV
infection and the sexual transmission of HIV. J Infect Dis 2004;189:1785–92.
^ Masciotra, S. Performance of the Alere Determine HIV-1/2 Combo Rapid Test
with Specimens from U.S. HIV-1 Seroconvertes and HIV-2 Positive Specimens from
Ivory Coast.2012 HIV Diagnostics Conference; Atlanta, GA.
This press release contains forward-looking statements within the meaning of
the federal securities laws, including statements regarding the timing of the
completion of CLIA waiver trials and data submissions and the anticipated
future effectiveness and importance of the product in improving healthcare.
These statements reflect our current views with respect to future events and
are based on management's current assumptions and information currently
available. Actual results may differ materially due to numerous factors
including, without limitation, our ability to successfully manufacture and
distribute the product; market acceptance of the product; changes in law or
regulation and our ability to comply with regulatory requirements related to
the product, as well as the other risks described in the "Risk Factors"
section of our Annual Report on Form 10-K filed with the SEC on March 1, 2013,
as amended. We undertake no obligation to update any forward-looking
statements contained herein.
SOURCE Alere Inc.
Contact: Jackie Lustig, Director, Corporate Communications, Alere,
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