Information for Labs
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 is the basis of the APIFINY Test?
A. APIFINY technology is based on the measurement of eight prostate-cancer-specific autoantibodies in human serum. These autoantibodies are produced and replicated (amplified) by the immune system in response to the presence of prostate cancer cells. The autoantibodies are stable and, because of their amplification, are likely to be abundant and easy to detect, especially with small tumors characteristic of early-stage cancers.
The use of APIFINY results may supplement other information about prostate cancer risks, and may therefore aid in earlier risk assessment of prostate cancer and potentially increase survival rates. The autoantibody markers span a range of biological functions integral to prostate-cancer progression. Cell cycle, structure, and cellular signaling pathways are all represented.
Q. What makes APIFINY unique?
A. APIFINY is a prostate cancer risk assessment 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. Armune BioScience continues to conduct further research and development of the assay for commercial use.
Q. Why should physicians and patients consider the APIFINY test?
A. APIFINY measures unique biomarkers (autoantibodies) that may indicate a risk for prostate cancer. APIFINY test results may provide valuable information to aid physicians and their patients in making decisions regarding the right monitoring or cancer-detection program for them.
Q. How do the APIFINY biomarkers relate to each other?
A. Statistical analysis shows there is an interdependence among the biomarkers, which is further confirmed by their biological functions. Three of the biomarkers are associated with androgen-response regulation, and four are related to cellular structural integrity. The eighth biomarker has been implicated in prostate-cancer progression and a variety of cellular functions ranging from cellular signaling for numerous protein kinases to regulating cell cycle and cellular division. This eighth biomarker appears to be a potential bridge between the biomarkers in the other two general biochemical areas. More information about the biomarkers can be found in this article published in Translational Oncology.
Q. How is the APIFINY assay performed?
A. The APIFINY test process is performed in part using a qualitative immunoassay technique and in part using flow cytometry. The laboratory data generated by these methodologies are then subjected to a proprietary algorithmic analysis that generates a cancer-risk score. The APIFINY Test Directory has more information about the assay, test-score reference range, laboratory turn-around, and other test details.
Q. How should APIFINY be used?
A. APIFINY should be used in combination with other accepted methods of patient management. In men with elevated PSA, APIFINY is designed to aid in the assessment of prostate cancer risk and in the selection of patients for biopsy. Since APIFINY is based on a simple blood draw, it should be easily tolerated by most men. APIFINY score reporting was designed to optimize the identification of patients at lower risk. Many patients with lower-risk APIFINY scores may be placed on a routine clinical-monitoring program (i.e., semi-annual or annual checkup) with other accepted methods to assess the ongoing risk of prostate cancer. Men with higher APIFINY scores may require a more specific risk-assessment plan, which may include a biopsy.
Q. How do I order APIFINY?
A. Download, fill out, and sign the APIFINY Test Requisition and Advanced Payment Notification Forms on the Order APIFINY page. If you are using an APIFINY sample collection/mailer kit, the mailer will contain Test Requisition Forms along with Advanced Payment Notification forms, sample collection materials and directions. For more information about sample collection, handling, and shipment, refer to the APIFINY User Guide.
Q. Have you done clinical studies?
A. Two studies have been done. The first, a biomarker selection / algorithm development study, established the appropriate components for the assay. The second was a clinical validation study.
The assay biomarkers and the classifier algorithm were “locked down” in advance of the validation analysis using entirely independent samples. 519 samples were used in the biomarker selection / algorithm development study and 259 different samples were used in the clinical validation study. Samples were sourced from the University of Michigan, Johns Hopkins University, and Bioreclamation, a commercial sample provider. These studies fully complied with the recommendations of the 2012 report from the Institute of Medicine Committee on Omics-Based Predictive Tests, “Evolution of Translational Omics: Lessons Learned and Path Forward”; National Academy Press, Washington, DC. Results of the studies were analyzed by independent biostatisticians.
Based on the studies and on the design intent of APIFINY, a cut point of 59 was chosen to optimize the identification of patients at lower risk. Scores below 59 are lower risk, while scores at or above 59 are higher risk. APIFINY-test-score ranges and potential decisions are summarized below. Most relevant to the identification of patients at lower risk are the specificity of 80% and negative predictive value of 88%.
Q. Are APIFINY scores affected by age, race, or other factors?
A. Research is not yet complete in determining the affects of these demographics on APIFINY scores.
Q. How often should a patient get an APIFINY test?
A. APIFINY is a risk-assessment tool that is intended for use in men with elevated PSAs and who are potential candidates for a biopsy. APIFINY may be used as part of a routine clinical monitoring program (i.e., semi-annual or annual checkup) to assess a patient’s ongoing risk of prostate cancer.
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 patients are responsible for any portion of the payment, the Test Requisition Form offers them the option of using a check or debit/credit card. Payment will not be processed until the test is complete, and the report 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 a patients’ APIFINY test?
A. Every patient’s APIFINY test results, along with all patient and physician information, are held in the strictest confidence by Armune BioScience. Results from each test will be sent directly to the ordering clinic or physician’s office. More information about Armune’s policies regarding a patient’s Protected Health Information under HIPAA can be found here.
Q. How accurate is APIFINY?
A. APIFINY test results combined with existing patient information and 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. Should a patient use the results of APIFINY to delay or cancel other tests or treatment?
A. No. APIFINY is a risk-assessment tool and should be used in conjunction with all the other detection and risk assessment tools at a physician’s disposal. Prostate biopsy currently is the primary detection method and should be utilized following a physician’s recommendation. APIFINY results may indeed encourage greater compliance with follow-up biopsies by men who are identified at higher risk of having prostate cancer.
Q. Is APIFINY a genetic test?
A. APIFINY does not produce genetic information about the patient, and there are no tests for DNA sequences or gene mutations included in the APIFINY assay. The test measures only the level of certain autoantibody proteins in blood serum.
Q. How does the APIFINY technology compare with other prostate cancer tests?
A. APIFINY technology is the only cancer-specific non-PSA blood test available. APIFINY has no dependence on PSA and may directly indicate potential cancer activity in prostate tissue based on measurement of 8 prostate-cancer-specific serum autoantibodies created and amplified by the body’s own immune system. APIFINY’s advantages also include easy-blood-draw sample collection, low assay-rejection rates, and competitive lab turn around and pricing.
Q. How can I get more information?
A. If you have additional questions about APIFINY or Armune BioScience, please contact CustomerService@armune.com, or call 844-4Armune (844-427-6863).
If you have a question for us, please send us a message today or call 844-4Armune (844-427-6863).
1. Schipper M, Wang G, Giles N, Ohrnberger J. Novel prostate cancer biomarkers derived from autoantibody signatures. Transl Oncol. 2015;8(2):106-11.