New Prostate Cancer Blood Test Now Available in the US

Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non-invasive blood test that is three times more specific in detecting prostate cancer1than PSA (prostate-specific antigen). The new test’s accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.

The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood’s level of PSA — a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present.

"The PSA test is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer," said William Catalona, MD, principal investigator on the Prostate Health Index clinical study and urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, where they began using the phi test on patients in February. Dr. Catalona, who was the first physician in the U.S. to run the phi test, added, "However, the problem is that higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessarily invasive biopsies and an increased potential for patient harm."

The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of 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.¹

"The phi test helps physicians distinguish prostate cancer from benign conditions by utilizing three different PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels," said Kevin Slawin, MD, director, Vanguard Urologic Institute at Memorial Hermann Medical Group, clinical professor of Urology at Baylor College of Medicine and director of Urology, Memorial Hermann Hospital-Texas Medical Center, who performed some of the key research that led to the development of the phi test and who also began using the test in February. "We have seen first-hand how phi is much more accurate and reduces the need for prostate biopsies. And, the fact that phi is a simple blood test has been very appealing to our patients."

The phi test is now available to physicians nationwide through Innovative Diagnostics Laboratory (IDL), a national clinical reference laboratory specializing in personalized blood-based testing to find, understand and treat cancer.

“The phi test is a true advancement in the science of prostate cancer management and we are excited to be the first laboratory to offer this test to physicians throughout the U.S.,” said Tonya Mallory, CEO, president and co-founder of Innovative Diagnostics Laboratory. “The Prostate Health Index is a significant addition to our comprehensive menu of advanced clinical evidence-based blood tests that aid in early cancer detection."

"After years of collaboration with some of the world’s leading prostate cancer researchers and medical institutions who have studied the scientific and clinical benefits of phi, we are pleased that the test is now available to help physicians and patients with an elevated PSA test result, more accurately detect prostate cancer²," said John Blackwood, senior vice president, Chemistry/Immunoassay Business Unit, Beckman Coulter Diagnostics.

1 Beckman Coulter U.S. Prostate Cancer Pivotal Study Report
2 Hybritech p2PSA Instructions For Use

* The Prostate Health Index is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.