InterGenetics’ Breast Cancer Risk Test Enters International Market
News Mar 02, 2007
InterGenetics, a predictive medicine company, announced the international release of the first genetic-based, breast cancer risk test that incorporates both personal history and gene-based information to determine a woman’s future breast cancer risk.
Opaldia, a genetic health service provider with a network of clinics, will release OncoVue® in the United Kingdom and Ireland under an exclusive agreement.
“OncoVue has undergone over 7 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 5 geographic regions of the United States, giving us the support to introduce the test to an international market.” said Dr. Craig Shimasaki, InterGenetics CEO/president.
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 tube.
In the InterGenetics’ laboratories, 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.
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.
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.”
Warburton continued, “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.”
The OncoVue report shows a woman her risk assessment in three stages of her life; Pre-menopause, Peri-menopause, and Post-menopause and has been developed even for women who do not have a strong family history of cancer, or about 85% of the women who get breast cancer.
The OncoVue test has been released in the United States under a Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) study conducted by InterGenetics at Comprehensive Breast Centers and individual physician’s practices.
The centers participating in the study are Investigational Review Board (IRB) approved and operating under the protocols as recommended by the IRB to meet the requirements of the FDA Investigational Device Exemption study.
The test has been released in the U.S. through centers in Tucson AZ, Chicago IL, Indianapolis and Goshen IN, Rancho Mirage and Newport Beach CA, Tyler TX, Tacoma WA, Knoxville TN, Boise ID, Grand Blanc MI and Oklahoma City OK.
Opaldia 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.
InterGenetics and Opaldia will jointly participate in the development and sharing of best practice protocols for OncoVue in the UK and Irish markets.
The strategic partnership between InterGenetics and Opaldia will also expand the borders applying this science,” continued Dr. Shimasaki. “Opaldia is implementing medical programs in South Africa, the Middle East, Australia and in the Far East opening up potential future commercial markets for OncoVue.”
China is poised to introduce a new regulation on gene editing in humans. A draft of the country’s new civil code lists human genes and embryos in a section on personality rights to be protected. Experiments on genes in adults or embryos that endanger human health or violate ethical norms can accordingly be seen as a violation of a person’s fundamental rights.READ MORE