Personalized Test for Cancer Drug

The test has been cleared by the U. S. Food and Drug Administration (FDA).

The Invader molecular assay detects variations in the UGT1A1 gene that are associated with an adverse reaction risk. A clinical study has shown that patients with one of these variations have a risk of experiencing toxicity that is more than nine times that of patients without the gene. In a study submitted to the FDA, the Invader test was 100% accurate, compared to DNA sequencing, the standard for genotype determination.

The test was developed by Third Wave Technologies, Inc. (Madison, WI, USA), a developer and marketer of molecular diagnostics for a variety of DNA and RNA analysis applications. The company has selected Genzyme Genetics, a business unit of Genzyme Corp. (Cambridge, MA, USA) as its preferred laboratory partner because of Genzyme's commitment to developing personalized tests for cancer therapies. Genzyme will launch the test throughout North America as an addition to its own diagnostic testing menu.

"Third Wave's new test is a perfect example of how personalized medicine can be implemented today,” said Mara Aspinall, president of Genzyme Genetics. "With the Invader assay, physicians will now be able to better predict the proper dosage of therapy for patients, avoiding unnecessary side effects.”




Related Links:
Third Wave
Genzyme