InterGenetics reports that it has released the first genetic-based breast cancer risk test that incorporates both personal history and gene-based information to determine a woman's future sporadic breast cancer risk.
Opaldia will release OncoVue® in the U.K. and Ireland under an exclusive agreement. The OncoVue test has also been released in the U.S. under an FDA approved Investigational Device Exemption study conducted by InterGenetics.
"OncoVue has undergone over seven years of research, and the genetic information for this test came from the testing of over 8,000 women with and without breast cancer from five geographic regions of the United States, giving us the support to introduce the test to an international market," comments Craig Shimasaki, Ph.D., InterGenetics’ CEO and president.
The OncoVue test involves answering a medical history questionnaire and then using a mouthwash and depositing the fluid into a tube. In the InterGenetics' laboratories, the DNA is analyzed using the OncoVue CombiSNP™ technology that looks at combinations of genes to diagnose women with sporadic breast cancer. The OncoVue report shows a woman her risk assessment in three stages of her life: premenopause, perimenopause, and postmenopause.