££......Osmetech ......Smell the Success.....££

You're right Trout - it certainly wasn't aimed at you. Thanks for the steer.

However in the past the FDA used to post the minutes of their approval committee deliberations. This was what I was looking for and was surprised when I couldn't locate it. One thing I have found [which I'm sure you've already seen] are the many references to the Tag-It System - presumably this is a competitor and which seems well entrenched in the FDA's eyes. Here is a para or two pasted from the FDA website
=====Quote=====
Genomics and Medical Devices: A New Paradigm for Health Care
By Carol Rados

Imagine that a swipe of the inside cheek or a stick of the little finger could be used to predict whether or not certain types of cancer may be in your future. Theoretically, both can. Thanks to the advances in genetics, and with the clearance by the Food and Drug Administration of a growing list of genetic diagnostic testing devices, doctors are beginning to understand how certain diseases, or increased risks for certain diseases, pass from generation to generation.

The Tag-It Cystic Fibrosis Kit is one such device. Cleared for marketing in May 2005, Tag-It finds genetic variations in what scientists now know is the gene that causes cystic fibrosis--the most common fatal genetic disease in the United States. Made by Tm Bioscience Corp. of Toronto, Tag-It will help diagnose cystic fibrosis in children and identify adults who are carriers of the gene.......
========UNQUOTE=========
I'll continue to look at the FDA website as under the US FOI [Freedom of Information Act] the info should be there somewhere
regards
PG