Healthcare Industry News: C. difficile
News Release - March 30, 2009
Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK COMPLETE(TM) Rapid TestWALTHAM, Mass., March 30 (Healthcare Sales & Marketing Network) -- 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®, 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®, 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.
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.
TECHLAB®, 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
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