Next Generation Test for Prostate Cancer Gaining Ground in U.S.

RICHMOND, Va., Sept. 29, 2015 /PRNewswire/ -- Innovative Diagnostic Laboratory ("IDL"), a College of American Pathologists ("CAP")-Accredited clinical reference laboratory specializing in cancer risk assessment tests, is building momentum with the Prostate Health Index ("phi"), an innovative FDA-approved test to help physicians detect prostate cancer in their male patients. IDL added Beckman Coulter Diagnostics' test to its menu of advanced cancer risk assays in April of 2014, and over the past year has seen increasing adoption of the test amongst primary care practitioners, urologists and hospital networks.

phi has been recommended by the National Comprehensive Cancer Network (NCCN) as a blood test to improve specificity for prostate cancer detection in its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection. Inclusion in the NCCN Guidelines recognizes the benefit and clinical utility of phi to help bring about better prostate cancer diagnosis and for the appropriate use of prostate biopsies. IDL recently signed an agreement to provide The University of Texas MD Anderson Cancer Center ("MD Anderson") with phi testing services in addition to approximately 500 primary and specialty practices throughout the U.S. who are already using the test.

"We are finding there is significant interest in the phi test from hospitals and physician practice groups who are looking to demonstrate their commitment to value-based care for prostate cancer risk assessment and detection," said James Howard-Tripp, CEO of IDL. "IDL looks forward to working with health care professionals, providers and hospitals throughout the U.S. to provide patients with high quality, effective and efficient cancer risk assessment tests."

The phi test is a blood-based test that is three times more specific in detecting prostate cancer than prostate-specific antigen (PSA)*.² ³  While PSA is currently the most widely used screening test for prostate cancer, PSA results can often indicate the possibility of prostate cancer when none is present. Higher phi values, on the other hand, are associated with increased probability of prostate cancer, and with more aggressive disease.

Peer-reviewed published studies support the use of the phi test in men with total PSA values as low as 2 ng.¹ phi 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.⁴

For more information on phi, visit www.myinnovativelab.com/prostate-cancer  

About IDL ¹ ²

Innovative Diagnostic Laboratory ("IDL") is a national clinical reference lab specializing in personalized blood tests to help find, understand, and address cancer risk. Currently, IDL offers blood-based risk assessment tests for colon, lung and prostate cancer.

1. Catalona WJ et al. J Urol 2011;185(5):1650-5
2. J Urol. 2015 April; 193(4): 1163–1169. doi:10.1016/j.juro.2014.10.121.
3. Am J Clin Exp Urol 2014;2(4):343-350
4. http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090026a.pdf
   *At 90 percent clinical sensitivity.

SOURCE Innovative Diagnostic Laboratory

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