Chembio Commences CLIA Waiver Studies for DPP(R) HIV 1/2 Assay
MEDFORD, N.Y., April 18, 2013 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc.
(Nasdaq:CEMI) a leader in point-of-care diagnostic tests ("POCT"), announces
that the Clinical Laboratory Improvement Amendments (CLIA) waiver studies for
its DPP^® HIV 1/2 Assay have commenced. In December 2012, Chembio received FDA
approval for the DPP^® HIV 1/2 assay, which detects antibodies to HIV 1 and 2
in oral fluid, finger-stick whole blood (fingerstick), venous whole blood,
serum or plasma samples.
The CLIA waiver studies are required by the FDA to establish the quality
standards for laboratory testing, which ensures the accuracy, reliability and
timeliness of patient tests results regardless of where the tests are
performed. Currently, there are more than 180,000 testing sites in the U.S.
that are able to use CLIA-waived products.
Chembio's multi-site CLIA clinical study will test oral fluid, finger-stick
blood and venous whole blood samples prospectively collected from
approximately 1,000 subjects who are HIV positive and of unknown HIV status.
The study is expected to be completed within three to four months. Upon
completion of the required enrollment of subjects, Chembio plans to submit the
conclusions of the clinical study as a CLIA Waiver Application to the FDA. We
anticipate the FDA's review of the CLIA Waiver Application will be completed
during the fourth quarter of 2013.
"We are very pleased to commence the CLIA clinical testing for our DPP^® HIV
1/2 Assay. It is a key component for Chembio as we finalize our commercial
strategy to launch the DPP^® assay in the U.S.," noted Lawrence Siebert,
Chembio's Chief Executive Officer. "With more than 1.2 million Americans
estimated to be living with HIV and approximately 20% of them unaware they are
infected with the virus, rapid HIV tests are playing a critical role in the
U.S., as they have globally, to help identify those with HIV and to prevent
disease transmission. The market for these tests is expected to grow
significantly with the 2012 recommendations made by the U.S. Preventive
Services Task Force that embrace the 2006 Center for Disease Control's
recommendations that mandate insurance reimbursement for routine HIV testing."
About DPP^® HIV 1/2 Assay
The DPP^® HIV 1/2 assay detects antibodies to HIV 1 and 2 in oral fluid,
finger-stick whole blood (fingerstick), venous whole blood, serum or plasma
samples. The DPP^® HIV 1/2 assay provides a simple "reactive/non-reactive"
result. In a clinical evaluation of over 3,000 patients across three
countries, the diagnostic sensitivity of the DPP^® HIV 1/2 assay to detect HIV
infection ranged from 99.9% to 100% for fingerstick specimens and 98.9% to
100% for oral fluid specimens. The diagnostic specificity of the DPP^® HIV 1/2
assay was 100% for fingerstick specimens and 99.9% to 100% for oral fluid
specimens. The test is intended to be used in the preliminary diagnosis of
patients with HIV in point-of-care settings such as public health and other
clinics, hospital emergency rooms and physician offices.
The DPP^® HIV 1/2 Assay is the only rapid test in the U.S. that does not use
lateral flow or other older flow-through technologies. DPP^® HIV 1/2 delivers
visual results within approximately 15 minutes, is simple to use, requires
minimal sample size, has a shelf life of 24 months, and does not require
refrigeration. Providing results at the point-of-care eliminates the chance
that patients at risk would not return or call back for results, thereby
improving prevention efforts of forward transmission.
DPP^® HIV 1/2 features a comfortable swab for collection of oral fluid samples
and provides sharp distinct test lines due to the proprietary DPP^®
technology. In addition, a proprietary sample collection system in this assay
enables each sample to be contained in a convenient, closed collection vial,
or Sampletainer™, which provides additional sample for repeat testing,
allowing greater testing flexibility over other systems that do not have
separate sample collection or that use open vials for stirring blood samples.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing $10 billion point-of-care
testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests
are marketed in the U.S. by Alere, Inc. (formerly, Inverness Medical
Innovations, Inc.). Chembio markets its HIV STAT-PAK^® line of rapid HIV tests
internationally to government and donor-funded programs directly and through
distributors. Chembio has developed a patented point-of-care test platform
technology, the Dual Path Platform (DPP^®) technology, which has significant
advantages over lateral-flow technologies. This technology is providing
Chembio with a significant pipeline of business opportunities for the
development and manufacture of new products based on DPP^®. Headquartered in
Medford, NY, with approximately 170 employees, Chembio is licensed by the U.S.
Food and Drug Administration (FDA) as well as the U. S. Department of
Agriculture (USDA), and is certified for the global market under the
International Standards Organization (ISO) directive 13.485.
Statements contained herein that are not historical facts may be
forward-looking statements within the meaning of the Securities Act of 1933,
as amended. Forward-looking statements include statements regarding the
intent, belief or current expectations of the Company and its management. Such
statements, which are estimates only, reflect management's current views, are
based on certain assumptions, and involve risks and uncertainties. Actual
results, events, or performance may differ materially from the above
forward-looking statements due to a number of important factors, and will be
dependent upon a variety of factors, including, but not limited to Chembio's
ability to obtain additional financing and to obtain regulatory approvals in a
timely manner, as well as the demand for Chembio's products. Chembio
undertakes no obligation to publicly update these forward-looking statements
to reflect events or circumstances that occur after the date hereof or to
reflect any change in Chembio's expectations with regard to these
forward-looking statements or the occurrence of unanticipated events. Factors
that may impact Chembio's success are more fully disclosed in Chembio's most
recent public filings with the U.S. Securities and Exchange Commission.
CONTACT: Chembio Diagnostics
(631) 924-1135, ext. 125
Anne Marie Fields
Press spacebar to pause and continue. Press esc to stop.