Information for Patients
Q. What is APIFINY®?
A. APIFINY is the only cancer specific non-PSA blood test that may aid clinicians in the assessment of risk for the presence of prostate cancer.
Q. What makes APIFINY unique?
A. APIFINY is a 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 risk assessment test. It is well known that early detection improves long-term survival rates, therefore this technology along with current screening and detection methods, including family history, may provide additional insight for clinicians to aid in a clinical decision for determining a patient’s risk of prostate cancer.
Q. Who developed APIFINY?
A. 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.
Q. Why may the APIFINY test be right for me?
A. APIFINY measures specific biological markers known to be associated with an immune system response to prostate cancer. APIFINY test results, along with current screening and detection methods such as PSA and digital rectal exams, may provide valuable information to aid your physician in determining the best monitoring or cancer detection program for you.
Q. How often should I get an APIFINY test?
A. 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 patient-management plan (for example, during semi-annual or annual check-ups).
Q. How do I order APIFINY?
A. Consult with your physician about determining if APIFINY is an appropriate test for you. Your physician can order the test through the Armune BioScience laboratory in Ann Arbor, MI. Please refer to ordering information on our website. If your physician has questions before ordering or does not have access to the information on our website, contact us at 844-427-6863 or CustomerService@armune.com.
Q. Is the APIFINY test reimbursed by insurance?
A. Medicare, Medicaid, and certain private insurance companies may cover the APIFINY test. Armune BioScience will bill these programs and private insurance companies for the costs associated with this test. If you are responsible for any portion of the payment, the Test Requisition Form offers you the option of using a check or debit/credit card. Payment will not be processed until the test is complete, and the report is sent to your doctor.
Q. Is APIFINY FDA approved or certified in any way?
A. The APIFINY test is not FDA approved. It is a clinical test performed by Armune BioScience, Inc. and should not be regarded as investigational or for research. The Armune laboratory is regulated by the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The laboratory has been certified under CLIA to perform high-complexity clinical testing.
Q. Who will see the results of my APIFINY test?
A. 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.
Q. How accurate is APIFINY?
A. APIFINY test results combined with existing patient information and your physician’s clinical experience may aid in the assessment of prostate-cancer risk. In the most recent peer-reviewed published study on APIFINY,1 approximately 9 out of 10 men with an APIFINY score of less than 59 were cancer free and approximately 1 out 3 men with a score of 59 or above had prostate cancer.
Q. Can I use the results of the APIFINY test to delay or cancel surgery or other treatment?
A. 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. 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.
Q. Is APIFINY a genetic test?
A. 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.
Q. How can I get more information?
A. Review Armune’s website (www.armune.com), email CustomerService@armune.com, or call 844-4Armune (844-427-6863) for more information about Armune BioScience, the APIFINY technology, or the Armune BioScience Laboratory.
1. Schipper M, Wang G, Giles N, Ohrnberger J. Novel prostate cancer biomarkers derived from autoantibody signatures. Transl Oncol. 2015;8(2):106-11.