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Clinical trials began in the 4th quarter 2008 and the instrument with CD4 application will be launched to select markets in mid 2009. Inverness has featured the product at the 15th Annual Conference on AIDS and STIs (ICASA) in Dakar, Senegal on December 3-7, 2008. Information on the system can also be found on the product website at www.pimatest.com.
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In those who have been confirmed as being HIV positive, CD4 testing is a critical baseline measurement to gauge the state of their immune system and for clinicians to initiate antiretroviral (ART) HIV therapy. Measurement of CD4 levels indicates how far the disease has advanced and the risk to the patient of complications or debilitating infections. In addition to the baseline measurement, CD4 is also measured generally 2 to 4 times annually during course of HIV therapy.
The Inverness CD4 system's design is optimal for use both in point of care settings in the developing world as well as in the doctor's office in the developed world. It is a simple to operate, portable system with a rechargeable battery and provides rapid results. Using a small finger stick blood sample, the platform will be able to deliver not only CD4 cell enumeration but ultimately allow analysis of a wide array of additional markers.
It is estimated that there are more than 33 million people living with HIV/AIDS globally, 90% of which reside in the developing world. Of the nearly 30 million infected individuals in the developing world, less than 20% are aware of their HIV status. Further, it is estimated that less than 1/3 of those confirmed as being infected in the developing world have access to CD4 testing. The introduction of pima(TM) CD4 represents a significant step forward in realizing effective integration of testing, care and therapy at the point-of-care setting, where the need is greatest.
Ron Zwanziger, President and CEO Inverness Medical Innovations, stated, "We are very pleased with the interest generated from the presentation of the pima(TM) instrument and the CD4 assay at the important conference in Dakar and recognize the significant impact it will have upon the care of those living with HIV and AIDS in the developing world where few technologies are available at point-of-care. We anticipate broad possibilities for application of the instrument across our disease management portfolio."
The introduction of the Inverness point-of-care analyzer reflects the commitment by Inverness Medical Innovations to develop and bring to market innovative diagnostics to identify infectious disease and to enable effective health management of those with chronic conditions.
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.
This press release may contain forward-looking statements within the meaning of the federal securities laws, including statements regarding timing of the product release and 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.
