8 August 12 20:02–In developed countries the health authorities recommend that every citizen over 50 undergoes a colon cancer screening test. In most of the world, and Israel too, blood occult in feces is tested. The test is relatively convenient and cheap to perform but it is not very accurate. Only in the US and Germany are such tests carried out solely by colonoscopy, which is the most accurate, but highly inconvenient.
Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) had requested to replace the colonoscopy examination with its capsule, swallowed like food and which transmits a picture of the colon. The examination requires no anesthetic, making it far more convenient, although like the colonoscopy it requires an empty stomach and special diet on the days preceding the procedure.
However, today Given Imaging told the US Food and Drug Administration (FDA) that it will not be seeking the replacement of colonoscopies with its pill. Instead, the company will request FDA approval for patients unable to have a successful colonoscopy due to the anatomical structure of their colon, or are unable to withstand the colonoscopy procedure, or adamantly refuse to submit to the procedure.
In Japan, Given Imaging did not intend from the outset to register its pill as an examination but rather as a referral for those receiving suspicious blood feces results. Today such patients are referred to do a colonoscopy but only 25% actually do it. “They probably prefer to die,” said Oppenheimer analyst Yuval Yanai, “or they don’t trust the feces results.”…Read More>>