Frequently Asked Questions (FAQs)

Patient FAQs

Clinician FAQs

Patients FAQs

Q. Who is InterGenetics® and what do we do?
A. InterGenetics® is a personalized medicine and targeted cancer therapeutics company that develops cancer risk predictive tests that can accurately estimate the likelihood that an individual will develop cancer. Knowing a patients risk allows the patient and the physician to take proactive steps to prevent the disease or catch it at its earliest stages where the outcomes are potentially more favorable. InterGenetics® first product is a test called OncoVue® Breast Cancer Risk Test that will predict a woman’s individual risk of developing breast cancer. OncoVue® takes both a woman’s genetic makeup and information related to her personal history to estimate her risk of developing breast cancer. The personal history measures are important because they represent factors that interact with a woman’s genes to determine her overall risk.

Back to top

Q. What information will be given on the report?

A. The OncoVue® Breast Cancer Risk score is presented as a numerical value. This number is used to determine the level of risk – standard, moderate, or high – and the score can be used to determine options. The individual results are plotted across three distinct phases of breast cancer risk in a women’s life – pre-menopause, peri-menopause, and post–menopause. The risk level is compared to that of a statistical average of all women’s risk so that a woman can put her own level of risk into perspective.

Back to top

Q. How long will it take to get the report?
A. The test results will be available to the provider within 5 business days of the specimen arriving at the InterGenetics® laboratory for analysis. Once received, the results are explained to the patient by a healthcare professional along with recommendations appropriate for their specific risk level.

Back to top

Q. What should women do with this information?
A. This is where your health care provider comes in. Those women with standard risk scores will continue to monitor their breast health through annual screening mammograms as recommended by their physician, keeping in mind that no woman is at NO RISK for developing breast cancer.

Those women with moderate to high risk scores will work with their healthcare provider to establish risk appropriate screening regimens and consider more sophisticated screening techniques, the use of cancer preventing medications, and lifestyle changes to manage their pre-disposition to breast cancer.

Back to top

Q. What is the ideal age to offer the OncoVue® Breast Cancer Risk test?
A. Because the OncoVue® test examines germ line DNA, the kind that you are born with, it is possible to test anyone at the time of birth. However, because OncoVue® uses personal and medical history information in the test results, and it is important for the patient to have the willingness to take some medical action based upon the results, InterGenetics'® recommends that women between the ages of 30 and 69 seriously consider taking the OncoVue® test.

Back to top

Q. How often should this test be done?
A. The OncoVue® Breast Cancer Risk Test is based on an individuals germ line DNA which would not change so the test could be done once in a lifetime. However, there may be improvements in the technology in the future that could provide additional information and environmental or medical issues at a later stage in a patient’s life that could ultimately modify a woman’s risk.

Back to top

Q. Are there other tests available?
A. The OncoVue® Breast Cancer Risk Test is the first genetic-based cancer risk test broadly applicable to women. Many of the genes that have an impact on breast cancer also impact other types of cancers. InterGenetics® will offer additional cancer risk tests in the future for ovarian, colon, prostate, skin, brain, and lung cancers.

Back to top

Q. What do the clinicians think?
A. The clinicians who are currently part of the Breast Cancer Risk Testing Network and offering the test are enthusiastic about having another tool to help them identify women that are pre-disposed to breast cancer. Early detection and intervention are important steps in achieving better outcomes through the use of cancer prevention drugs and more sophisticated surveillance techniques.

Back to top

Q. Where can I go to get the test?
A. The test is offered through members of the Breast Cancer Risk Testing Network. This is a growing nationwide network of comprehensive breast care centers that meet specific criteria enabling them to offer the services necessary to meet the physical and emotional needs of patients related to their test results. These centers are among the most innovative in the country offering patient education, state of the art screening and diagnostic services, and access to preventative treatment options. The list of participating centers is provided on the OncoVue® website BCRT Network testing locations.

Back to top

Q. Will insurance cover this test?
A. This test will initially be paid for by the patient. As the test is more widely used by the medical community and becomes standard protocol, insurance companies may begin to cover the test. At this time, some payors may reimburse for the patient education and/or consultation.

Back to top

Q. What if the OncoVue® test predicts a ‘high risk?’
A. By identifying women at high risk for breast cancer—before the disease occurs—measures can be taken to reduce the risk of getting the disease via the use of preventative medications or more sophisticated surveillance modalities such as MRI. By knowing who is at risk, more comprehensive and early-detection testing can diagnose the disease at its earliest stages, where long term survival is the greatest. Women who are unknowingly at ‘high risk’ for breast cancer may potentially be identified many years before a diagnosis, even with no strong family history of breast cancer.

Back to top

Q. What if the OncoVue® test predicts a ‘moderate’ risk?
A. The woman’s physician may recommend she maintain a risk appropriate schedule of mammograms and clinical breast exams and suggest possible lifestyle changes to reduce her risk of developing breast cancer.

Back to top

Q. What if the OncoVue® test predicts a ‘standard risk?’
A. Women identified as having ‘standard risk’ will benefit from the peace of mind that comes with knowing that their chances of having breast cancer are minimal. There is no ‘zero risk’ of breast cancer, so all women still need to continue with their normal mammogram schedule and regular visits to the doctor.

Back to top

Q. What can I expect from patient education and why is it required?
A. The patient education program is designed to prepare a patient for taking the OncoVue® Breast Cancer Risk Test. It is important that the patient understand the origins of breast cancer, the genetics behind the test, what the results mean, and what can be done after receiving the results. While many women would just like to know their results, InterGenetics® and the members of the Breast Cancer Risk Testing Network strongly believe women must receive this educational information along with their results so they can make informed decisions.

Back to top

Q. How can cells from the inside of my cheek indicate if I’m at high risk for breast cancer? Wouldn’t a blood test be more accurate?
A. The cells that are collected from the inside of the cheek contain the same DNA that is found in every cell in your body. There is no need to use a more invasive collection method.

Back to top

Q. How do I take the test?
A. The first step is to schedule an appointment with the center in your area that is a member of the Breast Cancer Risk Testing Network. On your first appointment, you will participate in the patient education program to learn more about breast cancer, genetics, and the test. At the end of the educational program, you will take the test by simply filling out the patient questionnaire, test requisition, and informed consent. Then, you will swish the mouthwash and deposit the sample into the tube provided. Your healthcare provider will send your DNA sample along with your paperwork and payment for the test to the InterGenetics® laboratory for analysis. You will be contacted by the breast care center for your results. Your healthcare provider will carefully explain your results and work with you to develop your personal screening and prevention plan, based on your specific risk level.

Back to top

Q. Is genetic discrimination prohibited by law?
A. The Health Insurance Portability and Accountability Act of 1996 provided the first federal protections against genetic discrimination in health insurance. In addition, the Senate passed the Genetic Information Nondiscrimination Act (GINA), approved by unanimous consent of 95-0 an amended version of H.R. 493, which passed the House April 25th 2007 by a vote of 420-3. The House is expected to take up the measure again quickly before sending it to President Bush to sign the measure into law. This legislation would prohibit group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. It would also bar employers from using individuals' genetic information when making employment decisions, such as hiring, firing, and promotions.

Back to top

Q. Who can gain access to my genetic based risk assessment results?
A. Genetic test results are strictly confidential and test results will only be released to the ordering physician.

Back to top

Q. Will this test detect the presence of breast cancer?
A. No, this test does not diagnose breast cancer. The purpose of this test is to provide a woman with an understanding of her individual risk of developing breast cancer at different stages of her life so that she is empowered to make decisions that can impact her medical future outcomes.

Back to top

Clinicians FAQs

Q. Who is InterGenetics® and what do we do?
A. InterGenetics® is a personalized testing and targeted cancer therapeutics company that develops cancer risk predictive tests that can accurately estimate the likelihood that an individual will develop cancer. Knowing a patients risk allows the patient and the physician to take proactive steps to prevent the disease or catch it at its earliest stages where the outcomes are potentially more favorable. InterGenetics® first product is a test called OncoVue® Breast Cancer Risk Test that will predict a woman’s individual risk of developing breast cancer. OncoVue® takes both a woman’s genetic makeup and information related to her personal history to estimate her risk of developing breast cancer. The personal history measures are important because they represent factors that interact with a woman’s genes to determine her overall risk.

Back to top

Q. How many genes/SNPs/combinations were looked at in the study?
A. OncoVue® is based on a large case/control associative study that examines common genetic polymorphisms and medical history variables. Currently, we examined 117 common polymorphisms (mostly SNPs) located in over 87 genes. These candidate polymorphisms were chosen for examination because they are believed to alter breast cancer risk. Most result in amino acid changes in the proteins encoded by the genes in which they occur. The medical history variables include answers to questions concerning women’s reproductive histories, family histories of cancer and a few other questions related to general health. In addition, we are identifying gene-gene interactions to more accurately estimate a woman’s risk of developing breast cancer. We expect that examination of only the most significant and informative common polymorphisms will be included in the commercially released version of OncoVue® Breast Cancer Risk Test.

Back to top

Q. How many participants were in the study?
A. Current studies involve approximately 12,000 individuals of whom over 3100 have been diagnosed with breast cancer.

Back to top

Q. How is the test conducted?
A. First the patient completely fills out the test questionnaire that includes questions similar to the Gail Model Questionnaire which provides lifestyle and personal history measures specific to the patient. The patient then swishes a commercially available mouthwash and deposits it into the collection tube provided. The test requisition and the informed consent must also be completed and returned to the InterGenetics® laboratory, with the other test components for processing. At the InterGenetics® laboratory, the DNA is extracted from the patient’s cheek cells and analyzed to determine the patient’s individual risk of developing breast cancer. The results are returned to the breast center within 5 business days of receiving the sample at the InterGenetics® lab.

Back to top

Q. How accurate are the results?
A. The numeric OncoVue® score is calculated at each life stage by analyzing each individual’s genetic information, family history, and lifestyle factors as compared to all other women tested using proprietary algorithms to determine the individual’s unique level of risk. The genetic analysis of the individuals information is extremely accurate (>99.999%). The OncoVue® score is an assessment based on the current knowledge of genes contributing to the individuals unique risk level. It is not a diagnosis, nor a guarantee. Women who have a lower level of risk than others may still end up getting the disease.

Back to top

Q. How will this be incorporated into a comprehensive breast care center?
A. OncoVue® will be part of the Breast Cancer Risk Management Program offered only through members of the Breast Cancer Risk Testing Network. This test serves as a tool to accurately identify patients who are appropriate for high risk protocols. OncoVue® is not intended to be a stand-alone test, but to be used as an additional measure in determining risk.

Members of the Breast Cancer Risk Testing Network have received training and supporting materials about OncoVue® to use with patients when inquiries are made about the test. Centers also receive materials that help to explain the test to their referring physician networks for use in promoting the test to their patients.

Back to top

Q. How will you handle patient education?
A. A patient education program is provided by InterGenetics® Incorporated and is an important component of the testing process. The patient education program informs the patient about breast cancer, genetic pre-disposition to breast cancer based on individual and family genetics, understanding risk assessment and scoring, and learning more about ways to manage their risk to achieve emotional well-being.

Back to top

Q. Is there reimbursement?
A. This test will initially be paid for by the patient. As the test is more widely used by the medical community and becomes standard protocol, insurance companies may begin to cover the test. Patient education and consultation will be an integral component of the assessment. At this time, some payors may reimburse for the patient education and/or consultation.

Back to top

Q. What information will be given on the report?
A. The OncoVue® score is presented as a numerical value. This number is used to determine the level of risk – standard, moderate, or high – and the score can be used to determine options. The individual results are plotted across three distinct phases of breast cancer risk in a women’s life – pre-menopause, peri-menopause, and post–menopause. The risk level is compared to that of a statistical average of all women’s risk so that a woman can put her own level of risk into perspective.

Back to top

Q. How long will it take to get the report?
A. The test results will be available to the provider within 5 business days of the specimen arriving at the InterGenetics® laboratory for analysis. Upon receiving the results, the results are explained to the patient by a healthcare professional and given to the patient with recommendations appropriate for their specific risk level.

Back to top

Q. What should women do with this information?
A. Most women perceive their risk to be higher than it actually is. Those women with standard risk scores will continue to monitor their breast health through standard screening regimens as recommended by their physician, keeping in mind that no woman is at NO RISK for developing breast cancer.

Those women with moderate to high risk scores will work with their healthcare provider to establish risk appropriate screening regimens and consider more sophisticated screening techniques, the use of cancer preventing medications, and lifestyle changes to manage their pre-disposition to breast cancer.

Back to top

Q. What is the ideal age to offer the OncoVue® Breast Cancer Risk test?
A. Because the OncoVue® test examines germ line DNA, the kind that you are born with, it is possible to test anyone at the time of birth. However, because OncoVue® uses personal and medical history information in the test results, and
it is important for the patient to have the willingness to take some medical action based upon the results, InterGenetics'® recommends that women between the ages of 30 and 69 seriously consider taking the OncoVue® test.

Back to top

Q. How often should this test be done?
A. The OncoVue® Breast Cancer Risk Test is based on an individuals germ line DNA which would not change so the test could be done once in a lifetime. However, there may be improvements in the technology in the future that could provide additional information and environmental or medical issues at a later stage in a patient’s life that could ultimately modify a woman’s
risk.

Back to top

Q. Are there other tests available?
A. OncoVue® Breast Cancer Risk Test is the first test to be released on this platform. Many of the genes that have an impact on breast cancer also impact other types of cancers. The InterGenetics® research team will incorporate our findings into additional tests linked to ovarian, colon, prostate, skin, brain, and lung cancers.

Back to top

Q. What do the clinicians think?
A. The clinicians who are currently part of the Breast Cancer Risk Testing Network and offering the test are enthusiastic about having another tool to help them identify women that are pre-disposed to breast cancer. Early detection and intervention are important steps in achieving better outcomes through the use of cancer prevention drugs and more sophisticated surveillance techniques.

Back to top

Q. What if the OncoVue® test predicts a ‘high risk?’
A: By identifying women at high risk for breast cancer—before the disease occurs—measures can be taken to reduce the risk of getting the disease via the use of preventative medications or more sophisticated surveillance modalities such as MRI. By knowing who is at risk, more comprehensive and early-detection testing can diagnose the disease at its earliest stages, where long term survival is the greatest. Women who are unknowingly at ‘high risk’ for breast cancer may potentially be identified many years before a diagnosis, even with no strong family history of breast cancer.

Back to top

Q. What if the OncoVue® test predicts a ‘moderate’ risk?
A. The woman’s physician may recommend she maintain a risk appropriate schedule of mammograms and clinical breast exams and suggest possible lifestyle changes to reduce her risk of developing breast cancer.

Back to top

Q. What if the OncoVue® test predicts a ‘standard risk?’
A. Women identified as having ‘standard risk’ will benefit from the peace of mind that comes with knowing that their chances of having breast cancer are minimal. There is no ‘zero risk’ of breast cancer, so all women still need to continue with their normal mammogram schedule and regular visits to the doctor.

Back to top