Business and Finance
WALTHAM, Mass. (Map) -
In connection with the meeting, Inverness provided information on its previously announced 4th generation rapid HIV diagnostic test, the Determine HIV-1/2 Ag/Ab Combo and disclosed publicly for the first time details on its unique Point-of-Care Analyzer upon which a first of its kind CD4 cell enumeration test will be deployed.
For individuals who have been confirmed as being HIV positive, testing for CD4, or T helper cells, is a critical baseline measurement to gauge the state of their immune system and for clinicians to initiate antiretroviral (ART) HIV therapy. It indicates how far the disease has advanced and the risk to the patient of complications or debilitating infections. CD4 is also measured at regular intervals during course of HIV therapy.
The Inverness CD4 system has been designed for use in point of care settings in the developing world, as well as in hospitals and in physician's offices in the developed world and potentially in the home as part of an enhanced health management program. It is a simple to operate, portable system with a rechargeable battery and provides rapid results in 15 minutes or less. Using a small finger stick blood sample, the platform may be able to deliver not only CD4 cell enumeration but ultimately provide diagnostic capabilities for a wide array of additional markers.
It is estimated that less then 1/3 of those confirmed as being HIV positive in the developing world have access to this critical information and the Inverness CD4 instrument will be the first device to enable low cost CD4 quantification at these point-of-care settings, where the need is greatest.
Clinical trials for the CD4 system will begin in the 4th quarter of this
year and the instrument will be launched to select markets in mid-2009.
Inverness plans to feature the product at the 15th Annual Conference on AIDS
and STIs (ICASA) in
Ron Zwanziger, President and CEO Inverness Medical Innovations, stated, "We are very pleased with the development progress of the analyzer platform and the broad possibilities for its application across our disease management portfolio. We also realize the immediate significant impact it will have upon the care of those living with HIV in the developing world where few technologies are available at point-of-care."
The Inverness CD4 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
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 Inverness' ability to complete clinical trials of the product within the time frame suggested and with results that support the anticipated performance of the new product; Inverness ability to secure and maintain the regulatory approvals or clearances necessary to sell the product in various markets; market acceptance of the product; Inverness' ability to successfully manufacture and distribute the product; 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.
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