Roche Diagnostics receives FDA clearance for new test on OMNI blood gas analyzers
Measurement of pH in pleural fluids expedites test results enabling quicker treatment for patients

Today, Roche Diagnostics announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for measuring pH in pleural fluid samples on the Roche OMNI blood gas analyzers. The Roche Diagnostics OMNI® Modular 1-9, OMNI® C, and OMNI® S1-6 instruments are the only blood gas analyzers in the industry cleared by the FDA to run this test.

According to the American College of Chest Physicians (ACCP), more than 1 million pleural effusions (excess fluid between the lungs and chest wall) are diagnosed in the U.S. each year. A pleural effusion can have many causes including infection, heart failure, liver disease, cancer, rheumatoid disease, esophageal rupture and trauma.1

“This is an important test for physicians and patients, particularly in the emergency room,” said Rod Cotton, Senior Vice President, U.S. Point of Care Diagnostics, Roche Diagnostics. “With this new testing parameter on the Roche OMNI blood gas analyzers, hospitals will be able to get quick results that are critical for diagnosis and treatment.”

“Without the pH measurement for patients with pleural effusions, we have to wait for the other tests to be completed such as chemistries, cultures, and cell counts. Certain situations call for immediate intervention such as chest tube drainage plus appropriate antibiotics. Measuring pH should help us recognize some of those situations within minutes instead of hours or days. Early intervention in some cases may help spare the patient the need for surgery," said Paul E. Bellamy M.D., Pulmonary and Critical Care, Kaiser Foundation Hospital Woodland Hills and Southern California Permanente Medical Group.

A 1998 report by the ACCP determined that only pH values provided by blood gas machines are sufficiently accurate when pleural fluid pH is used for decision making.2

Roche Diagnostics OMNI blood gas analyzers provide point-of-care settings with additional time-saving features including a fully-automated Quality Control system (Auto QC) with up to 40 days of QC onboard, zero maintenance electrodes, and liquid calibration which eliminates the need for gas tanks., and basic blood gas and pH results in less than 60 seconds.

The measurement of pH in pleural fluids is currently available on the Roche OMNI blood gas analyzers. There is no additional hardware or reagents required to perform pH testing on pleural fluid samples.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Diagnostics Division, with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide.

Roche Point of Care Diagnostics, a business area of Roche Diagnostics, supplies products and systems for near patient diagnostic testing in hospitals and outpatient settings.

Roche Diagnostics’ North American headquarters is located in Indianapolis, Ind. (www.roche-diagnostics.us) For further information, please visit our websites www.roche.us and www.roche-diagnostics.com

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OMNI is a trademark of Roche.

1. Rubens, Jeffrey et al. Pleural Effusions . eMedicine.com. April 21, 2005 .

2. Cheng, DS et al. Comparison of Pleural Fluid pH Values Obtained Using Blood Gas Machine, pH Meter, and pH Indicator Strip .
2. Chest 1998; 114:1368-1372.