Breast Cancer Risk Test Enters International Market

The first genetic-based, breast cancer risk test has been released that incorporates both personal history and gene-based information to determine a woman's future breast cancer risk.

The OncoVue test is easy for women to take, who first answer a simple medical history questionnaire, then swish a harmless mouthwash and deposit the fluid into a tub. DNA from the woman's cheek cells in the mouthwash are analyzed using the OncoVue CombiSNP technology that looks at combinations of genes, rather than any single gene alone. The test 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 the support to introduce the test to an international market.

Developed by InterGenetics (Oklahoma City, OK, USA), the OncoVue test has been released in the United States under a U.S. Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) study conducted by the company at Comprehensive Breast Centers and individual physicians.

Research has shown such gene and personal history combinations have a significant relationship to women diagnosed with ‘sporadic' breast cancer; the type of breast cancer affecting 90-95% of all women. The research also reveals a strong dependence on age for genetic contribution to breast cancer risk.

Opaldia (London, UK) will promote OncoVue in the UK and provide genetic counseling and other breast surveillance services in tandem with the testing. Samples collected in the UK will be sent to the InterGenetics laboratories in Oklahoma City for testing and reporting. Opaldia will use InterGenetics' patient education program, adapted for a UK audience, developed by i.d.e.a.s., the management buy-out story-telling arm of Disney/MGM.

Elaine Warburton, Opaldia's chief executive commented, "Opaldia is the UK's premier private provider of genetic health services. Many of our patients worry about their risk of developing breast cancer, and in the UK, we have a ‘one size fits all' national breast-screening program, which has the potential to miss cancers in women under 50. OncoVue is a perfect fit for Opaldia's unique Breast Care program as the test can now identify those women at greater risk of developing sporadic breast cancer and who would therefore benefit from a carefully managed screening program at various stages in their lives.”

InterGenetics and Opaldia will jointly participate in the development and sharing of best practice protocols for OncoVue in the U.K. markets.


Related Links:
InterGenetics
Opaldia