


| Prostate Cancer Program
MacroArray Technology will initially focus its efforts on developing prostate cancer diagnostic products. Our primary objective is to obtain FDA approval to commercialize PCADM-1 as a clinical diagnostic test for prostate cancer. Our Prostate Cancer Program consists of:
PCADM-1 A urine-based diagnostic test for prostate cancer. This test is designed to replace the current PSA blood test currently in use. The advantages of the PCADM-1 test are that it is non-invasive, easily administered, safe and extremely cost effective for the diagnosis of prostate cancer. Urologists would no longer require the majority of patients to submit to blood tests, DREs or painful biopsies, whose accuracy may be compromised by unreliable PSA results in order to confirm the existence of prostate cancer. The availability of a simple yet reliable urine based test would facilitate periodic testing of patients to more accurately assess their medical condition and status of disease progression, remission or recurrence. MacroArray Technology has sourced an initial investment to initiate a multi-center clinical trial for an FDA Pre Market Approval (PMA) which requires that its test is clinically equivalent to or better than the PSA test. The FDA trial and PMA review and approval process is expected to be achieved within 18-24 months. The PCADM-1 test is expected to eventually replace the PSA test for the diagnosis of prostate cancer and perhaps more importantly, the identification of individuals who do not have the disease. Upon FDA review and PMA approval of the clinical trial results, the Company intends to license the test to a leading clinical diagnostic providers or diagnostic supply company. PCADM-2 A serum-based marker for prostate cancer found only in the serum patients with prostate cancer. We believe that the PCADM-2 serum test combined with the PCADM-1 urine test will provide for a significantly greater sensitivity in the diagnosis of prostate cancer, hopefully approaching >90%. Our early development stage products include HGPIN-1, a urine based marker for pre-malignant cancer (i.e. high grade prostatic intraepithelial neoplasia), and CAM-1, a serum-based marker for colon cancer. Current diagnosis of colon cancer depends largely upon a stool-DNA test or expensive and invasive colonoscopy examinations. This marker is only found in the serum of colon cancer tissues, not normal tissues, and is intended to replace stool-based and DNA based tests currently in use. |
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A Comparison of PCADM-1 to Conventional PSA Tests Therapeutics Discovery Technologies |














