• Prostate cancer is the #1 1 non-skin cancer among men. Patient Information What is your Apifiny™ Score? • About 1 man in 7 will be diagnosed with prostate cancer during his lifetime.1 • Talk to your physician about Apifiny, the only cancer specific, non-PSA blood test that may aid clinicians in the detection of prostate cancer. Apifiny™ Prostate Cancer 0 Lower Risk 59 Higher Risk 100 Risk Assessment The only cancer specific, non-PSA blood test that may aid clinicians in the detection of prostate cancer 1. www.cancer.org/cancer/prostatecancer Apifiny™ Prostate Cancer 0 Lower Risk 59 Higher Risk 100 Risk Assessment The only cancer specific, non-PSA blood test that may aid clinicians in the detection of prostate cancer Apifiny™ Prostate Cancer 0 Lower Risk 59 Higher Risk What is your Apifiny™ Score? 100 Risk Assessment Armune BioScience, Inc. www.armune.com 401 West Morgan Road Ann Arbor, MI 48108 Toll Free Helpline: 844-427-6863 www.armune.com CT-026A Rev.03 06/08/15 Copyright © 2008-2015, Armune BioScience, Inc. What is Apifiny? How do I order Apifiny? How accurate is Apifiny? Apifiny is a prostate cancer specific blood test that does not rely on PSA values. The technology measures the body’s immune response to cancer. Consult with your physician about determining whether or not Apifiny is an appropriate test for you. Your physician can order the test through Armune BioScience’s laboratory in Ann Arbor, MI. Please refer to ordering information on our website. If your physician has questions before ordering and/or does not have access to the information on our website, contact us at 844-4276863 or [email protected]. According to independent statistical analysis, the Apifiny test results may correlate well with prostate cancer risk. As with any test, you and your physician should discuss Apifiny test results and how they may relate to any other tests and clinical information obtained during routine exams in order to determine the next steps in your care. Is the Apifiny test reimbursed by insurance? No. We must emphasize that Apifiny is not intended as a stand-alone decision making tool. Assessing the risk for prostate cancer is complex and your physician will rely on a number of factors to determine the most appropriate care plan for you. What makes Apifiny unique? Apifiny is a prostate cancer diagnostic technology that takes advantage of a man’s immune system which generates autoantibodies against cancer in prostate tissue. These autoantibodies produced by the immune system are detectable in a patient’s blood, providing the basis for Armune’s minimally invasive diagnostic test. It is well known that early detection of cancer can improve long term survival rates, so this technology may potentially have a profound impact on prostate cancer. Who developed Apifiny? The Apifiny technology is derived from research at the University of Michigan under the direction of Arul Chinnaiyan, MD, PhD. Armune BioScience was formed in 2008 to conduct further research and development in order to prepare the technology for commercial use with physicians and patients. Why should I consider the Apifiny test? Apifiny measures unique biomarkers that may indicate a risk for prostate cancer. Apifiny test results, along with current screening and detection methods, such as PSA and digital rectal exam, may provide valuable information to aid your physician in determining the best monitoring or cancer detection program for you. How often should I get an Apifiny test? Apifiny is a tool that may be used for patients with elevated PSA levels of greater than 2.5 ng/ml. The Apifiny risk score may aid a physician in determining potential next steps in assessing a patient’s risk of prostate cancer. Your physician may order Apifiny as a component of your ongoing health management (for example: during semi-annual or annual check-ups). Medicare, Medicaid, and certain private insurance companies may cover the Apifiny test. Armune BioScience will bill these programs and private insurance companies. If you are responsible for any portion of the payment, the Test Requisition Form offers you the option of using check or debit/credit card. Payment will not be processed until the test is complete and the report sent to your doctor. Is Apifiny certified in any way? The Armune BioScience Laboratory is a commercial reference laboratory, certified and regulated by the federal Clinical Laboratory Improvement Amendments (CLIA) law established in 1988 (CLIA ‘88). The laboratory’s CLIA Certificate permits it to perform Apifiny and other highcomplexity medical tests. Apifiny’s technology research, validation study, and performance data are published in peer reviewed journals. Who will see the results of my Apifiny test? Your Apifiny test results, along with all patient and physician information, are held in the strictest confidence by Armune BioScience. Results from your test will be sent directly to the ordering clinic or physician’s office. More information about Armune’s policies regarding your Protected Health Information under HIPAA can be found on our website. Can I use the results of the Apifiny test to delay or cancel surgery or other treatment? Apifiny is a risk assessment tool that may best be used in patients with an elevated PSA greater than 2.5 ng/ml. Apifiny should be used in conjunction with other treatment, screening, and detection tools available to your physician. Is Apifiny a genetic test? The Apifiny test does not produce genetic information. The test measures only the level of certain autoantibody proteins in blood. Some people may come from families that have an inherited (hereditary or genetic) disposition for prostate cancer. There are some genes identified that relate to prostate cancer and information about all or some of these may be important to your physician. Based on your family history, your physician may choose to discuss genetic testing with you. Consult your physician if you have further questions about genetic testing or inherited forms of prostate cancer.
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