Third Wave Technologies Inc. won U.S. approval Monday to market a genetic blood test that could help make some medicines more personalized by allowing doctors to adjust drug dosages and minimize side effects.
The Food and Drug Administration said the test, called the Invader UGT1A1 Molecular Assay, so far has only been shown to work with Pfizer Inc.’s colon cancer drug Camptosar, but future data could link it to other drugs.
“There is, we think, a lot of potential for this to be applied to other drugs,” FDA spokeswoman Julie Zawisza said.
While the drug’s label includes some specific information on Camptosar, known generically as irinotecan, it was not clear if that would require the company to seek additional FDA approval, she said.
Third Wave’s test works by picking up differences in the UGT1A1 gene, which makes an enzyme that helps metabolize drugs. The differences in the gene affect how much medicine enters the blood stream. Higher levels of the drug in the blood can lead to more side effects.
“While the pharmacogenetic market is just beginning to emerge, we believe it will become increasingly valuable,” Third Wave President and Chief Executive Officer John Puisis said in a statement.
Shares of the Madison, Wisconsin-based firm closed up 51 cents, or nearly 11 percent, to $5.17 Monday on Nasdaq.
The company submitted an outside study of 66 colon cancer patients taking Camptosar that found those with a certain variation in the UGT1A1 gene had a higher risk of toxicity, the FDA said.
“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,” FDA officials said in a statement.
The agency added that the test is a tool to help doctors, who should also consider the patient’s age, liver and kidney function, and any other drugs they are taking.
