Decipher Biosciences Achieves Major Medicare Milestone for Decipher Prostate Genomic Tests

First Precision Oncology Company to Receive Medicare Coverage for Both Favorable and Unfavorable Intermediate Risk Prostate Cancer

San Diego – December 3, 2019

Decipher Biosciences, a leader in the field of urologic cancer genomics, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), issued a final local coverage determination (LCD) for use of Decipher® Prostate Biopsy in men diagnosed with favorable and unfavorable intermediate-risk prostate cancer.

In 2019, an estimated 56,000 men in the U.S. will be diagnosed with intermediate-risk prostate cancer.  Most of these patients will receive surgery, radiation with or without hormone therapy, or will be carefully  monitored over time. Currently, the factors that are used to make the treatment determination are limited in scope and their ability to identify aggressive disease.  The Decipher Prostate Biopsy genomic test has been shown to be a better predictor of disease progression in more than 1,000 unique patients over a wide range of clinical validation studies.

“We believe that use of Decipher Prostate Biopsy in intermediate-risk men with prostate cancer helps to match selection and intensity of treatment with the metastatic potential of the tumor, decreasing the number of men who are over- or undertreated, resulting in improved patient outcomes,” said Tina Nova, PhD, president and chief executive officer of Decipher Biosciences. “For a single test to be applicable across the spectrum of therapeutic options, including monitoring, surgery, radiation, and the addition of hormone therapy, is a significant breakthrough for the management of patients with prostate cancer.”

The Medicare LCD, “Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Intermediate Risk Disease,” will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.  The final LCD is posted on the Centers for Medicare and Medicaid Services (CMS) website and will become effective on January 6, 2020. LCDs are subject to annual review by the MAC.

Decipher Biosciences also has effective Medicare coverage for use of Decipher Prostate in men with very low and low risk prostate cancer as well as men with adverse pathological findings after surgical removal of the prostate. Collectively, along with this new LCD, Decipher Prostate genomic tests have Medicare coverage for indications which address an estimated 146,000 men with prostate cancer in the U.S. in 2019.

About Decipher Prostate and Decipher GRID

Our Decipher Prostate genomic tests are clinical, commercially available oncology tests that provide a genomic assessment of tumor aggressiveness for individual patients newly diagnosed with prostate cancer and after surgical removal of the prostate. Decipher Prostate Biopsy is indicated for men with localized prostate cancer at diagnosis, and Decipher Prostate RP is indicated for men after prostate-removal surgery.  Decipher tests can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our real-world evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.

About Decipher Biosciences

Decipher Biosciences is committed to improving patient care, initially focused on urologic cancers. Our novel prostate cancer genomic testing products, Decipher Prostate Biopsy and Decipher Prostate RP, provide valuable information about the underlying biology of a patient's tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient's entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Decipher Biosciences is headquartered in San Diego, California. Decipher, Decipher GRID, and GRID are registered trademarks of Decipher Biosciences.

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