StatSure and Chembio Agree to End Litigation and Enter Agreement to Commercialize HIV Barrel Technology
October 05 2006 - 7:30AM
PR Newswire (US)
MEDFORD, N.Y. and FRAMINGHAM, Mass., Oct. 5 /PRNewswire-FirstCall/
-- StatSure Diagnostic Systems, Inc. (OTC:SSUR) (BULLETIN BOARD:
SSUR) and Chembio Diagnostics, Inc. (OTC:CEMI) (BULLETIN BOARD:
CEMI) announced today that they have entered into a series of
agreements that provide Inverness Medical Innovations, Inc.
(AMEX:IMA) with exclusive worldwide marketing rights to Chembio's
FDA-cleared, point of care, rapid, SURE CHECK(R) HIV 1/2 product
for the detection of HIV 1 & 2 antibodies. This test utilizes
StatSure's patented barrel technology, designed to provide
convenient, safe, accurate and integrated single-use, rapid HIV
antibody screening, and to minimize exposure to infectious agents;
it will be exclusively manufactured by Chembio for Inverness'
distribution. Chembio and StatSure have entered into a Settlement
Agreement pursuant to which all matters in their litigation
regarding SDS' barrel patent and other matters have been settled.
The Settlement Agreement, which is related to the parties'
three-way agreements with Inverness (details of these agreements
are being announced separately), provides that Chembio and StatSure
will equally share the profits, and that they will act jointly in
the HIV barrel field towards commercializing this technology and
its ensuing products for the HIV market. The settlement combines
each company's HIV barrel intellectual property, including an
exclusive manufacturing license from StatSure to Chembio of its
barrel patent for all HIV applications. Recently the CDC formally
issued new recommendations for routine HIV testing for all
Americans between the ages of 13 and 64. Chembio anticipates
receiving a CLIA (Clinical Laboratory Improvement Act) waiver from
the FDA for these products soon, which will greatly expand the
number of potential professional sites at which these tests could
be performed. Chembio's SURE CHECK(R) HIV 1/2 product is approved
for use with finger- stick or venous whole blood, plasma, and
serum, and has sensitivity and specificity performance
specifications of 99.7% and 99.9% respectively; furthermore these
HIV products have a twenty-four month shelf life, which is
substantially longer than competing products. SDS' patented barrel
technology enables convenient, direct collection of a whole blood
sample from the finger tip without need for a separate sample
transfer device. This format also results in a closed system
designed to reduce exposure to potentially infectious material.
Lawrence Siebert, President of Chembio commented, "We are pleased
to end the litigation with StatSure and enter this new agreement so
that we can deploy our capital more productively. We look forward
to working together with StatSure and Inverness to capitalize on
the significant global opportunity for the HIV barrel product."
Steve Peltzman, President of StatSure commented, "Litigation is
always a time-consuming, expensive win-lose battle. Our Settlement
represents an authentic win-win-win for each of the parties
involved and certainly jump starts our ability to commercialize
this important technology. We now are partners in the HIV Barrel
Field and intend to add and receive significant value to and from
this strategic relationship." ABOUT CHEMBIO Chembio Diagnostics,
Inc. (OTC:CEMI) (BULLETIN BOARD: CEMI) , 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(R) 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(TM)), for its next generation HIV and
other rapid tests. For additional information please visit
http://www.chembio.com/. Chembio has scheduled an investor web cast
and conference call l for Tuesday October 10, 2006 at 4:30 p.m. EDT
to discuss these transactions as well as its recent financing.
Details to follow in a subsequent press release. ABOUT STATSURE
StatSure Diagnostic Systems, Inc. (OTC:SSUR) (BULLETIN BOARD: SSUR)
is engaged in the development, manufacture and marketing of rapid
immunoassay tests for the detection of sexually transmitted and
other infectious diseases; in addition, the Company has developed
and is marketing a product line of patented, oral- fluid collection
devices. The Company's proprietary platforms provide significant
customer benefits and competitive advantages as compared to similar
products that are currently available. Improved accuracy, operator
convenience, and reduced risk of infection from collecting and
handling specimens, have been engineered into SDS products. All of
the company's diagnostic tests are based on the same easy-to-use
technology platform, thus facilitating the development of future
products. Certain of these products are sold in the United States
as well as internationally to various distributors for use in
clinical laboratories, hospitals, clinics, community- based
organizations and other public health organizations. Please visit
our website at http://www.statsure.com/. This press release may
contain forward-looking statements within the meaning of the
federal securities laws. These statements reflect the parties'
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, the future demand for HIV
testing products; Inverness' ability to successfully commercialize
the products; the intensely competitive environment in the relevant
markets and the risks and uncertainties described in periodic
reports filed by each of the parties with the Securities and
Exchange Commission under the federal securities laws, including
their periodic reports on Form 10-Q or Form 10-QSB, as applicable,
for the period ended June 30, 2006. The parties undertake no
obligation to update any forward-looking statements contained
herein. DATASOURCE: StatSure Diagnostic Systems, Inc. CONTACT:
James Carbonara of The Investor Relations Group, +1-212-825-3210,
for Chembio Diagnostics, Inc.; or Investor Relations of StatSure
Diagnostic Systems, Inc., +1-508-872-2625 Web site:
http://www.statsure.com/ http://www.salv.com/
http://www.chembio.com/
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