Message #27 From:
NewsBot Date: November 28, 2006 03:30:00 AM
CEMI News Chembio Receives CLIA Waiver for HIV 1/2 STAT-PAK(TM)
MEDFORD, N.Y.--(BUSINESS WIRE)--Chembio Diagnostics Inc. (OTCBB: CEMI) has received CLIA Waiver for one
of its two FDA-approved rapid HIV tests, HIV 1/2 STAT-PAK™.
The CLIA (Clinical Laboratory Improvement Act) waiver allows Chembio to
market these HIV tests to a potential market of approximately 189,000
laboratory entities across the United States, including doctors’
offices and clinics.
Larry Siebert, Chief Executive Officer of Chembio said, “CLIA
Waiver is an important milestone, as this now allows us to submit final
labeling changes to the FDA for marketing by Inverness Medical
Innovations (AMEX: IMA), our U.S. marketing partner for this product.
These changes will be submitted during December which should permit
sales to begin in the first quarter of 2007. We are glad that as we
approach World AIDS Day this Friday to be entering a US market that we
believe is expanding as a result of the recent CDC recommendations for
routine HIV testing in the United States. We believe therefore that
Inverness has an excellent opportunity to be successful with this
product and our other FDA approved product, SURE CHECK HIV®
1/2. A CLIA Waiver application for that product was submitted, and is
currently under review by the FDA.”
ABOUT CHEMBIO
Chembio Diagnostics, Inc., a developer and manufacturer of rapid
diagnostic tests for infectious diseases, is on the frontlines of the
global battle against the AIDS pandemic. The Company has received
marketing approval from the FDA for its SURE CHECK®HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid tests. The Company also
manufactures rapid tests for veterinary Tuberculosis and Chagas Disease,
and has developed a patent-pending technology, the Dual Path Platform
(DPP™), for its next generation HIV and other
rapid tests. For additional information please visit www.chembio.com.
FORWARD-LOOKING STATEMENTS
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 are estimates only, as the Company has
not completed the preparation of its financial statements for those
periods, nor has its auditor completed the audit of those results.
Actual revenue may differ materially from those anticipated in this
press release. Such statements 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, to obtain
regulatory approvals in a timely manner, and 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.
