Healthcare Industry News:  H. pylori 

Diagnostics FDA

 News Release - November 27, 2006

Otsuka Pharmaceutical Co., Ltd. Announces FDA Clearance for the RAPIRUN(R) H. pylori Antibody Detection Kit

TOKYO, Nov. 27 (HSMN NewsFeed) -- Otsuka Pharmaceutical Co., Ltd. (Head Office: Tokyo, Japan; president: Tatsuo Higuchi; Phone: +81-3-3292-0021) today announced that the company received U.S. Food and Drug Administration (FDA) clearance on November 16th, 2006 for its 510(k) application to market the RAPIRUN® H. pylori Antibody Detection Kit (RAPIRUN® Kit), the first test available in the U.S. market to detect anti-H. pylori IgG antibodies in urine.

Otsuka has become a leader in the field of H. pylori diagnostics. Additional Otsuka family technologies related to H. pylori include the BreathTek(TM) UBT (13)C-urea breath test for determination of H. pylori infection, and the UBiT®-IR300 and POCone(TM) Infrared Spectrophotometers for measurement of (13)CO(2) level in breath. These products are marketed in the U.S. by Meretek Diagnostics, Inc. (Lafayette, Colo.), a subsidiary of Otsuka Pharmaceutical Co., Ltd.

The RAPIRUN® Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against H. pylori in urine to aid in the diagnosis of H. pylori infection. The kit is suitable for use in both point-of-care and clinical laboratory settings. The test is easy to administer, economical and convenient for the patient.

Noninvasive testing for screening of H. pylori infection is preferred over methods that require endoscopy. Approximately 81% of dyspeptic patients presenting to primary care receive noninvasive testing in the U.S. Options include testing for specific anti-H. pylori IgG antibodies, urea breath tests (UBTs) and stool antigen tests.

The RAPIRUN® Kit has been developed as an in vitro diagnostic device employing the immunochromatographic method that can detect low levels of anti-H. pylori antibodies in urine. The operating procedures are simple and test results can be determined by visual inspection in about 20 minutes.

Recent studies show that detecting anti-H. pylori antibodies in urine to diagnose infection is an effective alternative to blood-based antibody tests. However, the concentration of IgG in urine is far lower than it is in serum. Because of the low concentration, a highly sensitive test like the RAPIRUN® Kit is required for detection of antibodies in urine.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka -- people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment and diagnosis of disease and on consumer products for the maintenance of everyday health.

The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US$6.8 billion in annual revenues in fiscal 2005.

For more information about Otsuka Pharmaceutical Co., Ltd. and the company's products, contact International Business Development at the e-mail address wwdi@otsuka.jp.


Source: Otsuka Pharmaceutical

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