Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK COMPLETE(TM)...

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Mon Mar 30, 2009 9:32am EDT

Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK
COMPLETE(TM) Rapid Test

WALTHAM, Mass., March 30 /PRNewswire-FirstCall/ -- Inverness Medical
Innovations, Inc. (NYSE: IMA), a global leader in enabling individuals to take
charge of their health at home through the merger of rapid diagnostics and
health management, announced today that it will begin marketing and
distributing the new C. DIFF QUIK CHEK COMPLETE(TM) rapid test as an in vitro
diagnostic aid for Clostridium difficile associated disease (CDAD). This
follows TECHLAB(R), Inc.'s recent clearance from the Federal Drug
Administration (FDA) to manufacture the product for Inverness. C. difficile is
responsible for the most common form of hospital-acquired diarrhea and
antibiotic-associated colitis. C. difficile is highly infectious and a
significant danger to the health of immunocompromised or elderly patients. The
infection can be life-threatening when not caught in time to allow for
appropriate therapy to combat the disease and thereby reduce morbidity
associated with CDAD. The new rapid test yields results within 30 minutes and
detects all strains of C. difficile, including the highly virulent strain
BINAP1/027 which is causing outbreaks of increasing severity and mortality
across Europe and North America.  Collective scientific data suggests that the
incidence of C. difficile infection (CDI) has recently increased in East Asia
and the Middle East, further highlighting the disease as a global epidemic. 
In US Hospitals alone, current annual spending is estimated at $40 million in
testing aimed at diagnosing CDAD patients in order to provide appropriate
therapy and control the spread of the disease.

While primarily a hospital-acquired disease, C. difficile infection is
increasingly occurring in community outpatient settings. This is causing a
major problem for hospital and community care environments because the number
of patients at risk for C. difficile infection is substantial. At present, the
incidence of infection has reached epidemic proportions.  Recently-released
results from the "National Prevalence Study of Clostridium difficile in US
Healthcare Facilities" indicate that the rate of infection, or colonization,
is 6.5 to 20 times greater than previous estimates. 

The C. DIFF QUIK CHEK COMPLETE(TM) test offered by Inverness Medical is the
only device that simultaneously detects both C. difficile glutamate
dehydrogenase (GDH) and C. difficile toxins A and B in one simple assay. It
can be used for screening while also confirming the presence of toxigenic C.
difficile strains. The test provides results in less than 30 minutes from
fecal samples, enabling rapid diagnosis and initiation of appropriate patient
management. With use of a C. difficile rapid test, patients can be effectively
isolated at an earlier stage of illness, reducing the risk of cross
contamination and widespread outbreaks.

The C. difficile antigen glutamate dehydrogenase (GDH) used in the test is
common to all strains of C. difficile and has been identified as an excellent
screening marker for the infection. The new C. DIFF QUIK CHEK COMPLETE(TM)
test, developed and manufactured by TECHLAB(R), Inc. in Blacksburg, VA, 
provides a more complete picture of the patient's disease state within one
single test format with quicker time to results and higher negative predictive
value (less false negative results) when compared to alternative existing
testing methods.
About Inverness
By developing new capabilities in near-patient diagnosis, monitoring and
health management, Inverness Medical Innovations enables individuals to take
charge of improving their health and quality of life.  A global leader in
rapid point-of-care diagnostics, Inverness' products, as well as its new
product development efforts, focus on infectious disease, cardiology,
oncology, drugs of abuse and women's health.  Inverness is headquartered in
Waltham, Massachusetts.

For more information about Inverness Medical Innovations, please visit our
website at http://www.invernessmedical.com.

About TECHLAB(R)
TECHLAB(R), Inc. continues to be at the forefront of C. difficile research and
are experts in the field of enteric diagnostics; and with Inverness Medical,
offer a wide range of testing formats for the detection of C. difficile
antigen glutamate dehydrogenase and toxins A and B that can suit all
laboratory practices and preferences.

This press release may contain forward-looking statements within the meaning
of the federal securities laws, including statements regarding the potential
benefits of the new product. These statements reflect Inverness' current views
with respect to future events and are based on its management's current
assumptions and information currently available. Actual results may differ
materially due to numerous factors including, without limitation, risks
associated with market acceptance of the product; Inverness' ability to
successfully manufacture and distribute the product; Inverness ability to
secure and maintain the regulatory approvals or clearances necessary to sell
the product in various markets; and the risks and uncertainties described in
Inverness' annual report on Form 10-K, and other factors identified from time
to time in its periodic filings with the Securities and Exchange Commission.
Inverness undertakes no obligation to update any forward-looking statements
contained herein.


SOURCE  Inverness Medical Innovations, Inc.

Doug Guarino, Director of Corporate Relations of Inverness Medical
Innovations, Inc., +1-781-647-3900
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