Panacea Pharmaceuticals, Inc. announced today that PC Detect(sm), the Company's prostate cancer screening test, is now available from Panacea Laboratories. PC Detect(sm) is a simple blood test, which is recommended as an adjunct to the prostate specific antigen (PSA) test and the digital rectal examination (DRE), the currently recommended prostate cancer screening methods.
The addition of PC Detect(sm) to the current screening methods is expected to improve the diagnosis of prostate cancer among men with prostate specific antigen (PSA) values below the currently recommended level for prostate biopsy. Panacea Laboratories, a division of Panacea Pharmaceuticals, is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The blood sample can be ordered by any physician and sent to Panacea for testing. The Company anticipates submission of a Pre-Market Application (PMA) to the U.S. Food and Drug Administration later in 2007 to facilitate development of a PC Detect(sm) kit, which will be commercialized through clinical laboratories around the country.
Prostate cancer is currently the most prevalent form of cancer in men and the second leading cause of male cancer deaths in the United States. The standard-of-care screening tools for prostate cancer used by physicians to determine whether to refer a patient for a prostate biopsy include the prostate-specific antigen (PSA) and the digital rectal examination (DRE).
The American Cancer Society (ACS) recommends that a PSA blood test and DRE be performed annually in men > 50 years old. However, the predictive value of an elevated PSA and/or an abnormal DRE is limited. PSA is a tissue-specific protein and has been shown to be elevated in patients with benign prostatic conditions as well as in patients with prostate cancer. About 25% of men recommended for prostate biopsy with a PSA of 4-10 ng/mL will be found to have cancer on biopsy, and a PSA > 4.0 ng/mL has a sensitivity of 46% for identification of patients who will be found to have prostate cancer over the next 10 years. According to the ACS, patients with a PSA > 10 ng/mL should undergo a prostate biopsy since >50% of these men are likely to have cancer.
However, men with PSA levels of 2-4 ng/mL are not routinely recommended to have prostate biopsies, despite the fact that almost 24% of men with PSA levels of 2.1 to 3.0 ng/mL will be diagnosed with prostate cancer as will almost 27% of men with PSA levels of 3.1 to 4.0 ng/mL, according to a study by Thompson et.al., published in 2004 in the New England Journal of Medicine.
PC Detect(sm) has demonstrated a sensitivity of greater than 90% in identifying men with prostate cancer who have PSA levels of 2-4 ng/mL. Punglia et.al. (2003) found that if prostate biopsies were performed only when the PSA level is greater than 4.0 ng/mL, 82% of cancers would be missed in those who are younger than 60 years of age, and 65% would be missed in those who are 60 or older. As such, PC Detect(sm) may aid in the identification of a significant number of men with prostate cancer at an earlier stage and facilitate improved outcomes.
PC Detect(sm), a CLIA laboratory service, is a new method for screening a patient's serum to help determine the likelihood that prostate cancer is present. PC Detect(sm) provides information to differentiate prostate cancer from benign conditions and to help guide both the physician and the patient regarding further diagnostic testing and management by measuring blood levels of Human Aspartyl (Asparaginyl) beta-Hydroxylase (HAAH), a cancer biomarker. HAAH has been established as an excellent biomarker for many types of cancer, including prostate cancer. The protein is typically undetectable in sera from cancer-free individuals, thus, an elevated serum protein level of HAAH is highly diagnostic for cancer.
"The addition of PC Detect(sm) to standard-of-care prostate cancer screening, with PSA and DRE, should significantly enhance a physician's ability to identify men at high-risk of having prostate cancer, even in those with PSA levels of 2-4 ng/mL," commented Pamela Jo Harris, MD, Vice President, Medical and Clinical Affairs at Panacea. "We are confident that the addition of PC Detect(sm) will help internists, family practitioners, and urologists better assess the need for a patient to have a prostate biopsy and to identify those likely to have prostate cancer."