Bob,
I had some time this weekend to do some surfing and found some more interesting information at the PharmInfoNet site: New Additions, 11 February 1997, H Pylori News:
pharminfo.com
Companies target H. pylori infection with a broad range of diagnostic assay products. Genetic Engineering News. 1996;16[16]:15, 36-37. I didn't notice any test under this section that looked like it could receive a CLIA waiver.
Helicobacter pylori and gastric cancer. Scandinavian Journal of Gastroenterology. 1996;31[Suppl.220]:23-26. "...Stomach cancer is the second most common fatal malignancy in the world. . . Using different odds ratio estimates gives different percentages, but even with the most conservative estimates, at least 31% and 52% of gastric cancers can be attributed to H. pylori infection in developed and developing countries, respectively, leading to about a third of a million new cases of cancer annually. This means that H. pylori is one of the most frequent established causes of cancer. Only tobacco, the human papillomaviruses, and the hepatitis viruses are known to carry a similar or greater cancer burden. Screening for H. pylori infection in, for example, men aged 55 to 59 would cost on the order of UK œ5000 to 10,000 per life saved, which is similar to the costs per life saved for cervical cytology and breast mammography..."
Mike |