New 20-Year Data Published in Urologic Oncology Validates Adverse Pathology as Predictor of Prostate Cancer Outcomes in Clinically Low-Risk Patients

--Results strongly support the use of the Oncotype DX® GPS™ test, the only genomic assay that reports individual values for adverse pathology risk, consistent with the new study findings--

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EXACT SCIENCES CORP

Nov 23, 2021, 09:08 ET

MADISON, Wis., Nov. 23, 2021 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, today announced the publication of results underscoring the importance of adverse pathology as a reliable and critical endpoint for risk-assessment in clinically low-risk prostate cancer patients.¹ Published in Urologic Oncology: Seminars and Original Investigations and led by study collaborators at the Cleveland Clinic, the findings showed that men who were discovered to have adverse pathology, following a radical prostatectomy, were 10 times more likely to develop metastatic disease and eight times more likely to die from their prostate cancer than those with favorable pathology, up to a 20-year follow up.¹ The findings strongly support the clinical use of the Oncotype DX Genomic Prostate Score® (GPS™) test, the only commercial genomic test that was specifically developed to improve assessment of a patient's risk of adverse pathology, beyond clinical factors alone, and optimized to perform in biopsy samples. ^2,3

"The critical clinical question urologists ask when treating their low-risk prostate cancer patients is whether active surveillance may be appropriate or if they may be harboring more aggressive disease that needs to be treated immediately," said Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. "These findings are important as they establish adverse pathology at radical prostatectomy as a strong prognostic factor for long-term prostate cancer outcomes and demonstrate the value of AP for assessing risk in this low-risk population, ultimately providing confidence when deciding between active surveillance or other immediate treatment strategies."

In the study, analyses were performed on a sample of 428 patients, largely clinically low and intermediate risk (10% being clinically high risk), treated with radical prostatectomy (RP) between 1987 and 2004. Adverse pathology was defined as either high-grade or high-stage disease (Gleason Grade 3 or above and/or non-organ confined disease, pT3 or higher). Patients with no AP at surgery had a nearly zero risk of metastasis and death even at 20 years, while metastatic and death events rose immediately and sharply in the group of patients who had adverse pathology.

"We developed the GPS test to fundamentally change how risk assessment at the time of biopsy for prostate cancer patients could be improved with genomics, and we chose adverse pathology as the actionable endpoint in all of our validation studies," said Rick Baehner, MD, chief medical officer of Precision Oncology at Exact Sciences. "These study results show that the combined risk of adverse pathology is strongly associated with worse long-term outcomes, supporting the clinical utility of the Oncotype DX® GPS test and the many patients who have put their trust in the GPS test to confidently manage their treatment decisions."

The Oncotype DX GPS test is backed by a robust body of clinical evidence in more than 9,000 men⁴ and Exact Sciences is committed to further strengthening the data supporting the expanded clinical utility of the test. Recently, the company has redesigned its patient test reports to reflect new clinical evidence and to answer the different clinical needs in low- and high-risk patients. With two tailored reports, the Oncotype DX GPS assay provides critical information for when active surveillance may be an appropriate decision in lower-risk patients and provides risk estimates to help inform treatment decisions for higher risk patients.⁴ The patient-friendly resources help facilitate discussions between patients and their healthcare practitioners by consolidating key prostate cancer characteristics in a single document for ease of reference during treatment management conversations. The new high-risk reports are currently available, and the new low-risk reports will launch December 2021.

For more information about Exact Sciences' Oncotype DX Genomic Prostate Score test and to view samples of the new patient test reports, visit www.oncotypeiq.com.

About the Oncotype DX Genomic Prostate Score® Test
The Oncotype DX Genomic Prostate Score® (GPS™) test is a genomic assay designed for men with clinically low- and high-risk localized prostate cancer to help guide treatment decisions at the time of diagnosis. Developed, clinically validated, and studied collectively in over 9,000 patients, the Oncotype DX® GPS™ test analyzes prostate cancer gene activity to predict disease aggressiveness to help refine risk assessment, as well as provides clinically meaningful endpoints.⁴ With two tailored patient reports, the GPS assay provides useful information for when active surveillance may be an appropriate decision, as well as risk estimates to help inform treatment decisions for higher risk patients. To learn more about the Oncotype DX GPS 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® 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: Oncotype, Oncotype DX, Oncotype DX Genomic Prostate Score, and GPS are trademarks of Genomic Health, Inc.. Exact Sciences and Cologuard are registered trademarks of Exact Sciences Corporation.

Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. You should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact: Stephanie Spanos, [email protected], 608-556-4380


¹ Brooks et al. Urologic Oncology: Seminars and Original Investigations. 2021.
² Klein et al. European Urology. 2014
³ Cullen et al. European Urology. 2015
⁴ Data on file