Healthcare Industry News:  i-STAT 

Diagnostics FDA

 News Release - July 26, 2006

Abbott Receives FDA Clearance for i-STAT(R) BNP Test to Diagnose Congestive Heart Failure

New Point of Care Test Helps Physicians Quickly, Accurately Assess Difficult-to-Diagnose Heart Failure at Patient's Bedside

EAST WINDSOR, N.J., July 26 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its i-STAT BNP cartridge, a new point of care diagnostic test used to quickly assess the level of BNP (brain naturietic peptide) in patients in emergency rooms, heart failure clinics and observation units, laboratories and other critical care settings. BNP is a protein secreted into the bloodstream by heart tissue during congestive heart failure (CHF), a disease in which the heart loses its ability to adequately pump blood throughout the body, and which results in a build-up of fluid pressure inside the heart.

CHF is often challenging to diagnose because its key signs and symptoms -- such as shortness of breath and fatigue -- are relatively non-specific and often associated with other conditions. Determining the level of BNP in a patient's blood, an objective marker of the presence of heart failure, can help physicians quickly and more accurately diagnose and assess disease severity. Additionally, BNP testing at the patient bedside accelerates triage, diagnosis, treatment and disposition of patients, clearing overcrowded emergency departments.

The BNP cartridge is designed for use with the i-STAT System, a market-leading automated hand-held blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow health care professionals to make rapid diagnosis and treatment decisions for their patients.

"Nearly 80 percent of heart failure patients admitted to the hospital come through the emergency department," said Thomas Bugliosi, M.D., medical director, Abbott Point of Care. "These patients present with shortness of breath, which doctors must assess to differentiate between heart attack, pulmonary embolism, asthma, the flu or a number of other conditions in addition to CHF. Point of care testing for BNP is an important advance for patients and physicians, who can make differential diagnosis and informed decisions on patient care more quickly and accurately."

Faster Test Results May Lead to Better Outcomes

The new i-STAT BNP cartridge is a single-use, in vitro diagnostic test intended for use by license practitioners to measure the level of BNP with just a drop of blood, delivering lab-accurate results in approximately 10 minutes at the patient's bedside. (Current clinical guidelines state that turnaround time for BNP results should be less than 60 minutes). Research has shown that early diagnosis and treatment of heart failure with intravenous drug therapy in the emergency department reduced length of stay by 35% and mortality for admitted patients by 60%. (ADHERE Registry http://www.adhereregistry.com/publications/manuscripts/ADHERE_in_RICM.pdf ).

About Abbott Point of Care

Abbott Point of Care, headquartered in East Windsor, N.J., develops, manufactures and markets critical medical diagnostic and data management products for rapid blood analysis. The company's premier product is the i-STAT System, a market-leading hand-held blood analyzer used in emergency departments, surgical suites, neonatal intensive care units and other critical care settings that is capable of performing a panel of commonly ordered blood tests on two or three drops of blood at the patient's side.

Utilizing 18 different self-contained test cartridges, along with the Precision PCx(TM) and PCx Plus(TM) glucose test strips, the i-STAT System delivers lab-accurate testing for blood gases, electrolytes, chemistries, coagulation, hematology, glucose and cardiac markers in just minutes. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patients' care.

About Abbott

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 .


Source: Abbott

Issuer of this News Release is solely responsible for its content.
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