Oncotype DX Genomic Prostate Score® Result Shows for the First Time the Value of the Test to Guide Treatment Plans for Unfavorable Intermediate-Risk Prostate Cancer Patients

Findings, published in Urology, suggest that GPS™ results can help guide the intensity of clinical management in this higher-risk patient population

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EXACT SCIENCES CORP

Jun 16, 2020, 08:00 ET

MADISON, Wis., June 16, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS) today announced the publication of results highlighting the performance of the Oncotype DX Genomic Prostate Score^®(GPS™) result in patients with unfavorable intermediate (UFI)-risk prostate cancer. Published in Urology, the new results demonstrate the GPS test is a strong independent predictor of critical outcomes in UFI-risk prostate cancer patients.

"While men with very low-, low- and favorable intermediate-risk prostate cancer often choose between active surveillance and treatment, men with unfavorable intermediate-risk disease must make decisions about how aggressive their treatment plan should be," said Jennifer Cullen, Ph.D., M.P.H., lead author of the publication and Associate Director of Cancer Population Sciences at the Case Comprehensive Cancer Center in Cleveland. "These new findings, which demonstrate for the first time the GPS test as a strong predictor of critical endpoints in UFI-risk disease, indicate that Oncotype DX^® testing can aid physicians and UFI-risk prostate cancer patients in their decision-making process. The GPS score may help in decisions regarding treatment intensity and empower patients in their care choices."

For this new publication, additional statistical analyses were conducted of GPS results from two previously published cohort studies in men treated with radical prostatectomy. The study included 299 intermediate-risk patients, 175 of whom were classified as UFI-risk. Results showed that UFI-risk patients with a GPS test result >40 had outcomes consistent with high-risk disease and a poor prognosis, indicating they may benefit from more aggressive therapies. In contrast, UFI-risk patients with a GPS value <40 had outcomes similar to favorable intermediate-risk patients, suggesting less aggressive therapy may be needed.

The GPS test has been shown in multiple studies to be a strong independent predictor of several critically important outcomes in men with very low, low, and favorable intermediate-risk prostate cancer. Findings from these new analyses support guideline inclusion of the GPS test in the broader population of UFI-risk patients.¹

"Men and families facing a prostate cancer diagnosis have many questions and tough decisions in determining the best course of treatment. Tools like the GPS test can help patients have confidence in navigating a treatment pathway," said Jamie Bearse, chief executive officer of ZERO - The End of Prostate Cancer. "This is an important step forward for expanding access and coverage for intermediate-risk prostate cancer patients, as they can use the GPS test to help best guide and determine their treatment."

About the Oncotype DX Genomic Prostate Score^® (GPS^™) Test
Developed by Genomic Health, a wholly-owned subsidiary of Exact Sciences Corp., and based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX® GPS test is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor and the patient's likelihood of prostate cancer metastasis and death at 10 years. The GPS test is included within NCCN Guidelines^® as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease and is covered by Medicare and multiple private insurance companies in the United States. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard^® and Oncotype DX tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

NOTE: In the US and certain other jurisdictions, Genomic Health, Oncotype, Oncotype DX, Oncotype IQ, Breast Recurrence Score, Recurrence Score, DCIS Score, Colon Recurrence Score, Genomic Prostate Score, GPS, AR-V7 Nucleus Detect, Pass It On: Until Every Woman Knows, and Making Cancer Care Smarter are trademarks of Genomic Health, Inc., an Exact Sciences corporation.

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¹ Cullen J, Kuo HC, Shan J, et al. The 17-Gene Genomic Prostate Score Test as a Predictor of Outcomes in Men with Unfavorable Intermediate Risk Prostate Cancer. Urol. 2020 (In Press)