Inverness Medical Innovations, Chembio Diagnostics, Inc. and StatSure Diagnostic Systems, Inc. Announce Agreements to Market Rap
05 Octubre 2006 - 7:30AM
PR Newswire (US)
WALTHAM and FRAMINGHAM, Mass., MEDFORD, N.Y. Oct. 5
/PRNewswire-FirstCall/ -- Inverness Medical Innovations, Inc.
(AMEX:IMA), Chembio Diagnostics, Inc. (OTC:CEMI) (BULLETIN BOARD:
CEMI) , and StatSure Diagnostic Systems, Inc. (OTC Bulletin Board:
SSUR) announced today that they had entered into a series of
agreements that provide Inverness with exclusive worldwide
marketing rights to Chembio's FDA-cleared, point of care, rapid
test for the detection of antibodies to HIV. The test utilizes
Inverness' proprietary lateral flow technology as well as
StatSure's patented "barrel" technology designed to maximize ease
of use and minimize exposure to infectious agents. In addition,
Inverness obtains exclusive US marketing rights to Chembio's
proprietary lateral flow cassette test (HIV 1/2 STAT PAK(TM)) for
antibodies to HIV which will complement Inverness' market-leading
Determine rapid HIV test (only sold outside the U.S.). In
conjunction with this agreement, Chembio and StatSure will equally
share in the profits relating to the application of the barrel
technology and have settled past litigation between them. Details
of this settlement are being announced separately. Both Chembio HIV
tests are FDA-cleared for use with fingertip blood, whole blood,
serum or plasma for the detection of HIV-I as well as HIV-II
antibodies. The proprietary barrel format has been designed to
provide distinctive customer benefits relating to convenience,
safety and product performance. Both tests achieved a sensitivity
of 99.7% and a specificity of 99.9% in clinical trials. Inverness
also has granted Chembio a license to its lateral flow technology
to manufacture and market the Chembio cassette HIV product and a
Chembio dipstick HIV test outside the US and to manufacture and
market certain defined veterinary and emerging disease tests.
Inverness will also receive non-exclusive worldwide marketing
rights under Inverness brands to this latter group of products and
has invested $2 million in a Chembio financing as announced
separately today. In addition, Inverness will also grant to SDS a
license to its lateral flow technology for an HIV cassette product
as well as certain other products. The addition of two new HIV
products, the FDA-cleared "barrel" and cassette formats, further
strengthens the Inverness line of point of care testing products,
already one of the broadest in the market. Rapid HIV testing is an
expanding area with strong growth potential in Inverness's key
markets of physician office and hospital testing as well as having
the potential to be sold through retail channels. The HIV products
will be introduced in the US as soon as FDA clearance is received
for the use of Inverness labeling. Commenting on the agreements,
Ron Zwanziger, CEO of Inverness, said, "We are very pleased to be
able to work with Chembio and StatSure to market these products.
The recently published revised HIV testing recommendations from the
CDC point to the need for screening all adults aged 13-64 as well
as for routine testing for pregnant women and persons at high risk
of infection." Lawrence Siebert, President of Chembio commented,
"This is a significant milestone for our company as we believe
Inverness will be able to achieve widespread distribution of our
products. We look forward to working with Inverness and StatSure on
the barrel product and HIV cassette in the US, and capitalizing on
the licenses we have received." Steve Peltzman, CEO of StatSure
commented, "Great technology, when married to outstanding
manufacturing and Inverness' marketing, can produce extraordinary
results. We believe this team will deliver those results as
customers around the world recognize their needs for rapid HIV
testing are best served by these new product entries." ABOUT
INVERNESS MEDICAL Inverness Medical Innovations is a leading global
developer of advanced diagnostic devices and is presently exploring
new opportunities for its proprietary electrochemical and other
technologies in a variety of professional diagnostic and
consumer-oriented applications including immuno-diagnostics with a
focus on women's health, cardiology and infectious disease. The
Company's new product development efforts, as well as its position
as a leading supplier of consumer pregnancy and fertility/ovulation
tests and rapid point-of-care diagnostics, are supported by the
strength of its intellectual property portfolio. Inverness is
headquartered in Waltham, Massachusetts. For more information about
Inverness Medical Innovations, please visit our website at
http://www.invernessmedical.com/. 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 for Tuesday October 10, 2006
at 4:30 pm 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: Inverness Medical Innovations, Inc.
CONTACT: Doug Guarino of Inverness, +1-781-647-3900; or James
Carbonara for Chembio, +1-212-825-3210; or Investor Relations for
StatSure, +1-508-872-2625 Web site:
http://www.invernessmedical.com/
Copyright