GenomeDx Biosciences, San Diego and Vancouver, British Columbia, Canada, has announced that Palmetto GBA, a national contractor that administers Medicare benefits, has issued a positive coverage determination through the MolDX program for the company’s Decipher prostate cancer classifier.

Developed in partnership with the Mayo Clinic, the Decipher prostate cancer classifier is a highly validated and commercially available genomic test for men with intermediate and high-risk prostate cancer. The test enables physicians and their patients to make more informed decisions about postoperative care. More than 50% of men diagnosed with prostate cancer are over the age of 65 and covered by Medicare.


Doug Dolginow, MD

Adding unique information to the treatment decision-making process, Decipher predicts cancer aggressiveness by looking for a genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Published studies have shown Decipher to be more accurate than prostate-specific antigen (PSA), Gleason score, and other clinical risk factors for predicting metastatic disease in men following prostate surgery.

“We are pleased to have had the opportunity to work closely with Palmetto GBA to establish coverage for Decipher,” says 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.”

In partnership with leading medical centers, GenomeDx 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.

“Our goal is to develop tests that will have a real benefit in terms of improved patient outcomes and savings to the healthcare system,” adds Dolginow. “The coverage of Decipher by Medicare is a huge step toward reaching that goal.”

Decipher is intended for testing men who have had prostate surgery and are considered by guidelines to be at 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 determination covers men whose prostate cancer has these characteristics, and who are weighing treatment options after a radical prostatectomy.

Clinical data generated at leading cancer centers during the development of Decipher showed improved accuracy in predicting aggressive prostate cancer, with the potential to spare patients the burden of life-altering side effects associated with additional treatment. In clinical validation and utility studies published in more than a dozen medical journals, 60% of men classified as high risk by traditional tools were reclassified as low risk by the Decipher test, and 98.5% of these men had no incidence of metastasis within 5 years of surgery.

Physicians changed their treatment recommendations 30% to 40% of the time 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.

For further information, visit GenomeDx Biosciences.