“PCLS is excited to work with an industry leader like Beckman Coulter to expand our urologic health offerings," said Joe Wiegel, PCLS President and CEO.
(PRWEB) May 08, 2015
Today, PCLS is pleased to announce that they have added Beckman Coulter’s Prostate Health Index (phi) to the urologic health testing menu, providing access to physicians across the United States.
According to the American Cancer Society, about 220,800 new cases of prostate cancer will be diagnosed this year. Prostate cancer occurs mainly in men older than 50 years of age and is the second leading cause of cancer death among American men, behind only lung cancer. Prostate cancer is a serious disease, but most men diagnosed with prostate cancer do not die from the disease. Screening and early detection are important in order for men to catch prostate cancer early, but choosing the right screening method can be difficult. The PSA (prostate-specific antigen) test is currently the most widely used screening test for prostate cancer, but because of its limited specificity, many patients undergo prostate biopsy unnecessarily.
The Prostate Health Index (phi) is:
- A simple blood test that is three times more specific for the detection of prostate cancer than PSA alone1
- The only multi-analyte prostate cancer blood test with FDA approval2
- The only multi-analyte blood test recommended in the National Comprehensive Cancer Network Guidelines (NCCN) for prostate cancer early detection.
The phi test helps physicians distinguish prostate cancer by combining three PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to accurately determine the probability of cancer in patients with elevated PSA levels and substantially reduce the number of negative biopsies. The increase in accuracy of the phi test over PSA addresses physician’s concerns regarding the decision to biopsy. Results from a multi-center clinical study found a 31 percent reduction in unnecessary biopsies due to false-positives as a result of using the phi test. 3
“PCLS is excited to be working with an industry leader like Beckman Coulter to expand our urologic health offerings. The phi test is a step in the right direction toward better prostate cancer management and PCLS is pleased to be one of only two laboratories offering the test to physicians throughout the U.S,” said Joe Wiegel, PCLS President and CEO. “According to a recent study published in the Journal of Urology, phi is 3 times more specific than PSA and offers doctors and patients a better way to determine if a prostate biopsy is appropriate. Currently, 75 percent of prostate biopsies performed are negative for cancer. Phi will help reduce the number of men that undergo a prostate biopsy unnecessarily, thereby reducing the number of complications associated with the biopsy procedure and treatment of non-life threatening disease.”
PCLS is an emerging esoteric laboratory that goes beyond testing to provide innovative solutions to healthcare problems. PCLS has a unique mix of services that are designed to inform physicians about their patient’s health status relative to several difficult to manage disease states including narcotic misuse and abuse, neonatal abstinence syndrome, titrating psychiatric drugs for debilitating mental disorders, recurrent/resistant bacterial infections, heart disease, gastrointestinal/urogenital disorders and cancers. The company has broadly invested in offering high value diagnostics that enable personalized and precision medicine to better manage these complicated disease states with the goal of improving health outcomes.
1. Catalona WJ, Partin AW, Sanda MG, et al. A multicenter study of [-2]pro-prostate-specific antigen combined with prostate-specific antigen and free prostate-specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/mL prostate-specific antigen range. J Urology 2011 May;185:1650-55.
2. phi is a combination of three Beckman Coulter assays: Access Hybritech PSA, Access Hybritech free PSA, and Access Hybritech p2PSA.
3. Beckman Coulter U.S. Prostate Cancer Pivotal Study Report