saw its shares jump after the company said the Food and Drug Administration agreed to establish its diagnostic system as a first-line tool in the detection of abnormalities of the small bowel, removing the "adjunctive tool" qualifier.
The FDA based its decision on clinical data from 32 independent studies with a total of 691 patients. The analysis compared the Given diagnostic system with other abnormality-detection methods, including gastroscopy, colonoscopy and CT scans.
Based on the agency's decision, Given expects private and public insurers to adjust their current policies and issue new policies to cover the first-line use of the Given M2A capsule for suspected disorders of the small intestine.
The Given diagnostic system uses the M2A capsule endoscope, the only noninvasive method for direct visualization of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule, which is ingested by the patient. The M2A capsule passes through the digestive tract, transmitting images, without interfering with the patient's normal activities. The system received clearance from the FDA in August 2001.
Shares of Given were up $2.14, or 25%, to $10.67 following the news.