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• 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 CustomerService@armune.com.
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.