Armune BioScience, Inc.
Armune has developed, validated and is marketing a non-PSA prostate cancer diagnostic assay. It plans to develop an assay for lung and breast cancer.
Armune BioScience is a medical diagnostics company formed to develop and commercialize unique technology for diagnostic and prognostic tests for prostate, lung and breast cancers. The technology utilizes autoantibodies created by the body’s own immune system to detect cancer at an early stage. When the immune system recognizes a cancer antigen, it creates an autoantibody to the antigen that is replicated by the immune system. Armune’s technology detects these autoantibodies in serum. A published study reported that lung cancer autoantibodies can be detected up to five years before clinical diagnosis of lung cancer , so Armune’s process of detecting these autoantibodies in serum offers a significant benefit and a competitive advantage.
Armune has developed and validated a new prostate cancer diagnostic assay that is being marketed under the Apifiny® trade name. The assay is marketed to urologists and primary care physicians as a Laboratory Developed Test (LDT) in accordance with the Clinical Laboratory Improvement Amendments (CLIA) guidelines.
The common practice when diagnosing prostate cancer is for the primary care physicians to request a PSA test in conjunction with an annual physical. Currently, the PSA test is the only prostate cancer screening test available, but it has several limitations. PSA is not a cancer-specific antigen and only indicates an abnormality of the prostate gland. As a result, an elevated PSA level may be prostate cancer, but it may also be the result of an enlarged prostate (BPH), an inflammation (prostatitis) or a urinary tract infection. Due to the limitations of PSA, there are unnecessary referrals from primary care to urology where additional tests/procedures are needed to determine if the man has prostate cancer. Under current American Urological Association guidelines, a PSA level greater than 2.5 ng/mL is suggestive of prostate cancer and the patient is normally referred to a urologist. The urologist will evaluate a number of factors when deciding whether the high PSA level indicates prostate cancer; the gold standard is to perform a TRUS (transrectal ultrasound) procedure and biopsy (normally 8 to 12 needles inserted into the prostate to obtain tissue). The prostate tissue is sent to a pathologist and 70 to 80% of the time, the results are negative for cancer. The obvious question is whether these biopsies are negative because the needles missed the tumor or whether the elevated PSA is due to other benign causes. The urologist’s primary concern is the false negative patient. It is estimated that 20 to 25% of men with a negative biopsy actually have prostate cancer. Consequently, a patient can remain in a highly anxious, “watchful waiting” period until his condition significantly changes or the urologist deems a follow-up biopsy is warranted.
Armune’s Apifiny assay may help to minimize the number of unnecessary referrals from primary care to urology and reduce the number of unnecessary prostate biopsies.