Decipher is the first genomic test for postoperative prostate cancer to gain Medicare coverage
San Diego, January 14, 2015 – GenomeDx Biosciences today announced that Palmetto GBA, a national contractor that administers Medicare benefits, has issued a positive coverage policy through the MolDX Program for the company’s Decipher® prostate cancer classifier. Decipher is a genomic test for prostate cancer that has shown in multiple published studies to be more accurate than PSA, Gleason score and other clinical risk factors in predicting metastatic disease in men following prostate surgery, allowing physicians and their patients to make more informed decisions about postoperative care. Over 50% of men diagnosed with prostate cancer are over the age of 65 and covered by Medicare.
“We are pleased to have had the opportunity to work closely with Palmetto GBA to establish coverage for Decipher,” said Doug Dolginow, MD, CEO of GenomeDx. “This is an important milestone for GenomeDx and the thousands of men who may benefit from the valuable genomic information provided by Decipher. Our goal is to develop tests that will have a real benefit in terms of improved patient outcomes and savings to the healthcare system. The coverage of Decipher by Medicare is a huge step toward reaching that goal.”
Decipher is a unique genomic test intended for men who have had prostate surgery and are considered by guidelines to be at high-risk for their cancer returning. These are men who have specific risk factors for cancer recurrence, including positive surgical margins, pathological stage T3 disease (seminal vesicle invasion, extraprostatic extension, bladder neck invasion) or rising PSA after initial PSA nadir. The Medicare coverage policy covers men with prostate cancer who have these features and are weighing treatment options after a radical prostatectomy.
Clinical data generated in the development of Decipher showed improved accuracy in predicting aggressive prostate cancer, and test results impacted physicians’ treatment decisions, with the potential to provide cost-savings to the healthcare system and to spare patients the burden of life-altering side effects associated with additional treatment. In published clinical validation and utility studies, 60 percent of men classified as high risk by traditional tools were reclassified as low risk by the Decipher test and 98.5 percent of these men had no incidence of metastasis within five years of surgery. Thirty to 40 percent of the time, physicians changed their treatment recommendations based on the results of the Decipher test. Further, recent studies suggest that Decipher may predict which men will benefit from radiation therapy after surgery and which may not.
The Decipher® Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decision-making process, Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic.
Decipher is covered by Medicare and multiple private insurance plans and is available to eligible US patients through their physicians.
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher®, a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers, the company has assembled the largest genomic catalogue of prostate cancer tumors in the world, representing billions of data points and more than 20 years of prostate cancer research expertise. Using advanced cloud-based bioinformatics, GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinician-scientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.