Effective August 2, 2022, mdxhealth has acquired the Oncotype DX GPS (Genomic Prostate Score) test from Exact Sciences. To help ensure a smooth transition for patients, continue to place orders for this test through the existing Exact Sciences portal until further notice. Additionally, Genomic Health Inc, part of Exact Sciences, will continue to perform the Oncotype DX GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the following press release. Questions? Email: gps@mdxhealth.com

Updated Guidelines from the American Urological Association Include Genomic Assays, such as the Oncotype DX® GPS Test, for the First Time in Localized Prostate Cancer Patients

“2022 Guidelines At-A-Glance, Prostate Edition” booklets available exclusively at Exact Sciences’ AUA2022 Booth (#647) in New Orleans, May 12-16

MADISON, Wis., May 11, 2022 – Exact Sciences Corp., a global leader in advanced cancer diagnostics, today announced the American Urological Association (AUA) updated their guidelines to include genomic assays, such as the Oncotype DX Genomic Prostate Score® (GPS™) test, when treating men with localized prostate cancer. The 2022 guidelines now state that clinicians may selectively use tissue-based genomic biomarkers when added risk-stratification may alter clinical decision-making. Exact Sciences will exclusively offer the at-a-glance booklets of the prostate cancer guidelines and exhibit its full portfolio of prostate cancer genomic tests at booth #647 during the AUA 2022 Annual Meeting from May 12-16 in New Orleans. This is the first in-person AUA meeting where Exact Sciences will feature its full Oncotype® portfolio of urologic genomic assays, including the Oncotype DX® GPS test for localized prostate cancer; the Oncotype MAP™ Pan-Cancer Tissue test for solid tumors, including advanced prostate cancer; and the Oncotype DX AR-V7 Nucleus Detect® test for metastatic castration-resistant prostate cancer.

"We're pleased that the updated guidelines recognize the impact genomic assays can have on treatment decision making for men with localized prostate cancer," said Daniel Shoskes, MD, MSc, FRCS(C), Medical Director of Urologic Oncology Medical Affairs at Exact Sciences and Emeritus Professor of Urology at The Cleveland Clinic. "While every patient is unique, clinical guidelines can help physicians offer the best evidence-based care using the most current data. The Oncotype DX GPS test is one of the most rigorously studied assays in localized prostate cancer patients, helping physicians refine risk stratification and make decisions between active surveillance and definitive treatment in low-risk patients, and to determine treatment intensity in higher-risk patients."

Key AUA activities featuring the Oncotype portfolio during the meeting include:



Thursday, May 12:Advanced Prostate Cancer: Practical Considerations for Incorporating Genomic Profiling in Practice

Topic: Learn How Genomic Profiling Can Help Guide Therapy Selection for Advanced Prostate Cancer  

Presenter: Gautam Jayram, MD 

Co-director, Advanced Therapeutic Center Urology Associates, PC
Time: 11:45 AM - 1:00 PM CT
Location: Room 267, Hilton New Orleans Riverside

Friday, May 13: Industry Clinical Update Theater #1043
Topic: A Case Based Discussion: Individualizing Localized Prostate Cancer Treatment Decisions with the Oncotype DX® GPS™ Assay    

Presenters: Stephen Canfield, MD

Chief of Urology / Memorial Hermann-Texas Medical Center / McGuire Distinguished Chair in Urology / McGovern Medical School at UTHealth/

Edward Uchio, MD

Jerry D. Choate Chair in Urologic Oncology / Director of Clinical Research / Professor, Department of Urology / University of California, Irvine

Daniel Shoskes, MD, MSc, FRCS(C)

Medical Director, Urologic Oncology Medical Affairs, Exact Sciences / Emeritus Professor of Urology, The Cleveland Clinic

Time: 9:30 - 10:30 AM CT

Location: Booth #647

Monday, May 15: Urologic Society for American Veterans Presentation

Title: Performance of the Oncotype DX Genomic Prostate Score® Test in African American Patients with Localized Prostate Cancer

Presenter: Daniel Shoskes, MD, MSc, FRCS(C)

Medical Director, Urologic Oncology Affairs at Exact Sciences / Emeritus Professor of Urology, The Cleveland Clinic

Time: 12:50 - 1:10 PM CT
Location: St. Charles Ballroom, Hilton New Orleans Riverside

In addition to the above presentations, Exact Sciences is hosting an Advocacy Roundtable on Sunday, May 15 from 7:00 - 8:30 AM CT. Leading prostate cancer and pan-cancer patient advocacy groups are invited to hear the latest updates on Exact Sciences’ prostate cancer genomic tests and to learn more about the company.

For more information about Exact Sciences’ AUA events and programming, visit https://www.oncotypeiq.com/en-US/announcements/AUA

 

About the Oncotype Portfolio of Prostate Cancer Tests

The Oncotype portfolio of prostate cancer tests applies advanced genomic science to reveal the unique biology of a patient’s tumor in order to help optimize cancer treatment decisions. The Oncotype DX Genomic Prostate Score test is designed for men with low-, intermediate-, and high-risk localized prostate cancer to help guide treatment decisions at the time of diagnosis, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. Patients with advanced prostate cancer, who eventually progress on hormonal agents, may benefit from the Oncotype MAP Pan-Cancer Tissue test, which delivers comprehensive tumor profiling and identifies actionable genomic and proteomic alterations within 3-5 business days[1] to determine eligibility for targeted therapeutic options. To learn more about the Oncotype urology portfolio of tests, 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 support patients before and throughout their cancer diagnosis and treatment. 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, GPS, Oncotype MAP Pan-Cancer Tissue, and Oncotype DX AR-V7 Nucleus Detect are trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are 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.

 

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Media Contact: Stephanie Spanos, sspanos@exactsciences.com, 608-556-4380

 

 

 



[1] Data on file. Turnaround time is based on qualified sample receipt.

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