Third Wave Technologies Corp. has received U.S. Food and Drug Administration (FDA) permission to release to market a new genetic analysis of blood (a test called Invader UGT1A1), which helps match patients to strictly defined dose of the drug Camptosar, for the treatment of colon cancer. The proposed test "sum" differences in the gene UGT1A1, which provides colorectal cancer patients with important information that could positively impact their treatment. Differences in gene affect how much of the drug gets into the bloodstream. Indeed, the high content of drugs in the blood can lead to a large number of side effects. A clinical study indicated that patients with one of these variations have a greater than 9-fold greater risk of experiencing toxicity from Camptosar than patients without it. In the future, the test can be modified for the appointment of patients and other medical supplies.
Third Wave’s UGT1A1 test is built on the accuracy, scalability and ease of use of the company’s unique, patented Invader® chemistry. In a study submitted to the FDA as part of the company’s clearance application, the Invader® UGT1A1 test was 100 percent accurate compared to DNA sequencing, the standard for genotype determination.
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