In connection with the meeting, Inverness provided information on itspreviously announced 4th generation rapid HIV diagnostic test, the DetermineHIV-1/2 Ag/Ab Combo and disclosed publicly for the first time details on itsunique Point-of-Care Analyzer upon which a first of its kind CD4 cellenumeration test will be deployed.
For individuals who have been confirmed as being HIV positive, testing forCD4, or T helper cells, is a critical baseline measurement to gauge the stateof their immune system and for clinicians to initiate antiretroviral (ART) HIVtherapy. It indicates how far the disease has advanced and the risk to thepatient of complications or debilitating infections. CD4 is also measured atregular intervals during course of HIV therapy.
The Inverness CD4 system has been designed for use in point of caresettings in the developing world, as well as in hospitals and in physician'soffices in the developed world and potentially in the home as part of anenhanced health management program. It is a simple to operate, portable systemwith 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 delivernot only CD4 cell enumeration but ultimately provide diagnostic capabilitiesfor a wide array of additional markers.
It is estimated that less then 1/3 of those confirmed as being HIVpositive in the developing world have access to this critical information andthe Inverness CD4 instrument will be the first device to enable low cost CD4quantification at these point-of-care settings, where the need is greatest.
Clinical trials for the CD4 system will begin in the 4th quarter of thisyear and the instrument will be launched to select markets in mid-2009.Inverness plans to feature the product at the 15th Annual Conference on AIDSand STIs (ICASA) in Dakar, Senegal December 3-7, 2008.
Ron Zwanziger, President and CEO Inverness Medical Innovations, stated,"We are very pleased with the development progress of the analyzer platformand the broad possibilities for its application across our disease managementportfolio. We also realize the immediate significant impact it will have uponthe care of those living with HIV in the developing world where fewtechnologies are available at point-of-care."
The Inverness CD4 point-of-care analyzer reflects the commitment byInverness Medical Innovations to develop and bring to market innovativediagnostics to identify infectious disease and to enable effective healthmanagement of those with chronic conditions.
By developing new capabilities in near-patient diagnosis, monitoring andhealth management, Inverness Medical Innovations enables individuals to takecharge of improving their health and quality of life. A global leader inrapid point-of-care diagnostics, Inverness' products, as well as its newproduct development efforts, focus on infectious disease, cardiology,oncology, drugs of abuse and women's health. Inverness is headquartered inWaltham, Massachusetts.
For more information about Inverness Medical Innovations, please visit ourwebsite at http://www.invernessmedical.com.
This press release may contain forward-looking statements within themeaning of the federal securities laws, including statements regarding timingof the product release and benefits of the new product. These statementsreflect Inverness' current views with respect to future events and are basedon 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 completeclinical trials of the product within the time frame suggested and withresults that support the anticipated performance of the new product; Invernessability to secure and maintain the regulatory approvals or clearancesnecessary to sell the product in various markets; market acceptance of theproduct; Inverness' ability to successfully manufacture and distribute theproduct; and the risks and uncertainties described in Inverness' annual reporton Form 10-K, and other factors identified from time to time in its periodicfilings with the Securities and Exchange Commission. Inverness undertakes noobligation to update any forward-looking statements contained herein.
SOURCE Inverness Medical Innovations, Inc.
