What is Apifiny?
One of the most common assays used to diagnose prostate cancer is the prostate-specific antigen (PSA) test. This calculates the risk of the patient having cancer based on the levels of the PSA protein in the blood, which is produced by the prostate gland. However, this test has a high false-positive rate (when a patient is wrongly diagnosed with prostate cancer). As a result, many biopsies are performed unnecessarily, which can be an invasive and potentially risky procedure for the patient.
Apifiny aims to reduce the false-positive rate by providing a second test to help clinicians and patients make a more informed decision about proceeding with a biopsy.
Prostate cancer cells can trigger a particular immune response, where proteins called autoantibodies are secreted into the blood. Eight specific autoantibodies were identified as being prostate-cancer-specific. This was determined through the comparison of blood samples from 414 men (ages 40 to 70) with prostate cancer and 346 men (ages 25 to 40) who were cancer-free. The results of this study are published in the journal Translational Oncology.
How should Apifiny be used?
For the test, a blood sample is taken and sent for clinical testing to Armune BioSciences laboratories. The test assesses a different biomarker (a factor produced by the body that can indicate a particular disease) and is independent of the PSA assay.
Apifiny is recommended for men who have a PSA level greater than 2.5 ng/ml (nanograms of PSA per milliliter).
Apifiny should not be used to entirely replace other forms of testing (such as PSA assay or a biopsy).
What do the results mean?
The results will be in the form of a score from 0-100, which can be used to estimate the risk of the patient having prostate cancer. The greater the score, the higher the risk.
Based on a clinical validation study, Armune BioScience suggests that a patient with a score of less than 59 has a 90 percent chance of being cancer-free. With a score of 59 or more, approximately 33 percent of patients were found to have prostate cancer.
Armune BioScience entered into a co-marketing agreement with the biopharmaceutical company Aeterna Zentaris, giving the biopharma exclusive rights to promote Apifiny to medical professionals in the U.S.
Apifiny has not been approved by the U.S. Food and Drug Administration (FDA). It is a clinical test and should not be used for research. The labs assessing the Apifiny test have been certified to perform complex clinical testing.
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