Abbott Innovations Honored for Third Time in Five Years
ABBOTT PARK, Ill., Oct. 22 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) has received a 2007 Chicago Innovation Award for its m2000(TM) molecular diagnostic instrument (http://www.abbott.com/global/url/content/en_US/60.15:15/feature/Feature_0021.htm ) and the Abbott RealTime HIV-1 viral load test, the most sensitive test of its kind capable of detecting and precisely measuring all known strains of the human immunodeficiency virus (HIV).
Abbott's RealTime HIV-1 test, approved for use in the United States in May 2007, and run on the m2000 system, is the only viral load test of its kind that can detect and measure all group M, group N and group O strains of HIV-1 as well as non-B subtypes of the virus. The products offer physicians a quick and highly accurate test method to help ensure their patients receive the most effective treatment.
This is the third time in five years Abbott has been selected for a Chicago Innovation Award. In 2005, the company's PathVysion(TM) (http://www.pathvysion.com ) breast cancer test received the honor, and in 2003, HUMIRA(TM)(http://humira.com ), the first human monoclonal antibody drug for rheumatoid arthritis, won the award.
"At Abbott we're in the business of improving lives -- often saving lives. That's an important motivation in fostering innovation," said Miles D. White, chairman and chief executive officer, Abbott. "Patients depend on us for new and better medicines, diagnostics and nutritionals, and that inspires our scientists everyday. The m2000 and HIV-1 viral load test, PathVysion and HUMIRA are just a few examples of the caliber of research being conducted at Abbott to find solutions to unmet medical needs."
Sponsored by Kuczmarski and Associates and the Chicago Sun-Times, the Chicago Innovation Awards are intended to create awareness of the contributions of Chicago-area companies in developing innovative products that change the world. Abbott and other awardees will be recognized at a ceremony and reception tonight at the Goodman Theatre attended by some 400 local business, academic and government leaders.
About the Abbott RealTime HIV-1 test and the m2000 instrument
Since the first diagnostic tests for the HIV virus came on the market in 1985, public health authorities have been concerned about the virus' ability to mutate and create new strains of subtypes that may elude detection. Optimal treatment of HIV depends on accurate measurement of viral levels, but if variant subtypes are present and undetected, drug therapy could be ineffective.
While many of the variant strains of the virus are not as prevalent in the United States as other countries, new studies suggest that that the influx of immigrants from areas of the world where these strains are more common is increasing the number of newly diagnosed patients infected with variant HIV.
"With more than 20 years of experience in HIV testing, our scientists identified a particular region of the HIV genome resistant to the impact of mutations, and were able to develop the first and only viral load assay of its kind capable of detecting and measuring all known strains of HIV," said John Robinson, Ph.D., senior director, Research and Development, Abbott Molecular.
The RealTime HIV-1 assay is intended to monitor disease prognosis and for use as an aid in assessing viral response to antiretroviral drug treatments. Quantitative measurements of HIV-1 levels in blood have greatly contributed to the understanding of the process by which the virus infection leads to disease and have been shown to be an essential parameter in prognosis and management of HIV infected individuals. Decisions regarding initiation or changes in antiretroviral therapy are guided by monitoring plasma HIV-1 levels or viral load, CD4-T cell count and the patient's clinical condition. The goal of antiretroviral therapy is to reduce the virus in plasma to below detectable levels.
The RealTime HIV-1 test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
The RealTime HIV-1 test runs on the new Abbott m2000, an automated system that uses real-time polymerase chain reaction (PCR) to amplify, detect and measure minute levels of virus in blood samples as well as extremely high levels of these infectious agents. Real-time PCR enables the production of large quantities of DNA from very small samples in a short period of time, making it possible to detect extremely low levels of a virus's genetic material.
"The m2000 instrument in combination with the HIV-1 assay and Abbott-developed software gives clinical laboratories the ability to automatically and quickly measure very small levels of virus in patient samples, allowing labs to deliver highly accurate test results in a matter of hours," said Scott Safar, senior director, Systems Development and Support, Abbott Molecular.
PathVysion is a test for breast cancer patients that provides physicians with genetic information to help them predict if a particular type of cancer treatment may be effective for an individual patient. PathVysion fluorescence in situ hybridization (FISH) technology measures the number of copies of the HER-2 gene at the DNA level. Using fluorescent colors and a microscope, physicians count the actual number of HER-2 genes present in the cell nucleus. Results from the PathVysion kit are intended for use as an aid in selecting potential candidates for Herceptin(R) (trastuzumab) monoclonal therapy and as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node-positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy.
About Abbott's Molecular Diagnostics Business
Abbott Molecular, a division of Abbott based in Des Plaines, Ill., is an emerging leader in molecular diagnostics -- the analysis of DNA, RNA and proteins at the molecular level. Abbott Molecular's instruments and tests provide physicians with critical information based on the early detection of pathogens and subtle, but key changes in patients' genes and chromosomes. The products help physicians diagnose disease and infections earlier, select appropriate therapies and monitor disease progression. In addition to the RealTime HIV-1 viral load test and the Abbott m2000, Abbott Molecular's portfolio of products also includes innovative genomic tests for chromosome changes associated with congenital disorders and cancer.
In the United States, HUMIRA is approved by the Food and Drug Administration (FDA) for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti- rheumatic drugs (DMARDs). HUMIRA is also approved for reducing signs and symptoms in patients with active ankylosing spondylitis.
Earlier this year, HUMIRA was approved for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the use of TNF- blocking agents, including HUMIRA. Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Infections have also been reported in patients receiving HUMIRA alone. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Humira. The combination of HUMIRA and anakinra is not recommended and patients using HUMIRA should not receive live vaccines.
More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately 3.5 fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known. TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome. The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis and Crohn's disease, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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