Invader UGT1A1 Molecular Assay Wins U.S. FDA Approval

Filed in archive Genomics, Proteomics and Bioinformatics on August 26, 2005

It sound like some computer war game, but it's actually a blood test for detecting levels of expression of the UGT1A1 gene, which dictates the levels of a drug that enters into the bloodstream. Earlier this week, the Invader UGT1A1 Molecular Assay (from Third wave Technologies, Inc) won FDA approval for marketing the technology for use with other drugs, even though so far, it has been shown to work only with the colon cancer drug Camptosar (made by Pfizer, Inc., Generic name: Irinotecan).

"For a patient with a particular UGT1A1 gene variation, a dose of irinotecan that is safe for another person might be too high for this patient, raising the risk of certain side effects. There is, we think, a lot of potential for this to be applied to other drugs," FDA officials said.

Another step into personalised medical treatment.

Read Reuters report here.