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Four New Studies of Oncotype DX® Genomic Prostate Score™ (GPS) Reconfirm Value of Test in Guiding Early-stage Prostate Cancer Risk Assessment and Treatment Selection
"We now have 22 clinical studies, involving more than 4,200 prostate cancer patients, that distinguish Oncotype DX as the only test developed specifically for men who are deciding between active surveillance or definitive treatment. The test is validated to provide individualized information about both the current state and future risk of patients' prostate cancer," said
Kaiser Permanente Clinical Validation Study Confirms Oncotype DX GPS Predicts Biochemical Recurrence Across Full Spectrum of Prostate Cancer, Providing Improved Risk Stratification Beyond Clinical Risk Assessment
A large clinical validation study, conducted in collaboration with Kaiser Permanente Northern California, has reconfirmed that the Oncotype DX GPS is a strong independent predictor of biochemical recurrence (BCR), a rise in prostate-specific antigen (PSA) in patients following surgery, which is a longer-term outcome measure of aggressive disease. To evaluate whether the GPS predicts BCR across the full spectrum of clinical risk as defined by NCCN criteria, researchers used Kaiser's database of 6,184 radical prostatectomy-treated men diagnosed with very low-, low-, intermediate- and high-risk prostate cancer. Results showed that the GPS was strongly associated with BCR both alone (p < 0.0001) and after adjusting for PSA, clinical stage and central biopsy
"Biochemical recurrence following surgery identifies men for whom the surgery was not curative. Understanding a patient's individual risk for developing biochemical recurrence after treatment helps physicians and patients make well-informed treatment decisions," said
Additional data from the clinical validation study with
Prospective Study Demonstrates Oncotype DX GPS Is an Independent Predictor of High-risk Surgical Pathology (HRSP) in Men with Clinically Low-risk Disease
In previous retrospective cohorts, the GPS was validated as a predictor of adverse pathology and BCR in prostate cancer patients treated surgically with radical prostatectomy. In this new ongoing prospective observational study, conducted in a real-world, community healthcare setting, researchers analyzed the association between the GPS and HRSP in 122 men who elected to receive radical prostatectomy for initial disease management.
Results showed that the GPS was a significant, independent predictor of HRSP (p=0.018) across very low-, low- and intermediate-risk patients. The GPS remained significant after adjusting for NCCN risk group. These findings suggest that the test may be valuable in treatment planning for men with clinically low-risk prostate cancer who are at risk for HRSP and may need to consider adjuvant therapy after surgery.
Large Study Demonstrates that Medical Conditions Common in Prostate Cancer Patients Do Not Influence the Oncotype DX GPS
Validated molecular biomarkers can improve risk stratification in newly diagnosed patients with prostate cancer, but it is important to understand if biomarkers are influenced by common coexisting clinical conditions. Using data from the
Results showed that there was no significant difference in GPS results between men with or without obesity, hypertension, hypercholesterolemia, diabetes mellitus or lower testosterone. These findings support the value of using the test in eligible patients, even if they have these health conditions.
Study of Veterans Finds Oncotype DX GPS Helps Physicians Identify Appropriate Candidates for Active Surveillance while Finding Patients with Higher-risk Prostate Cancer
Active surveillance is a recommended management approach for low-risk prostate cancer, and studies have shown variable rates of active surveillance in the
Results showed that use of active surveillance was higher (74 percent) in veterans who received Oncotype DX than in veterans who did not (62 percent), with the largest increase observed in low-risk patients. The use of the test also helped improve risk stratification by identifying 24 patients who had more favorable pathology and 13 patients who had less favorable pathology than would be expected using NCCN criteria alone.
About the Oncotype DX® Genomic Prostate Score™ (GPS)
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX Genomic Prostate Score (GPS) identifies which clinically low-risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness. With more than 700,000 patients tested in more than 90 countries, Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX GPS, visit www.OncotypeDX.com or www.MyProstateCancerTreatment.org.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical studies and their impact on reimbursement and adoption of the company's tests; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize tests and expand into new markets domestically and internationally; the risk that the company has all rights necessary to commercialize its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing
tests and any future tests it may develop; the risks of competition; and the other risks set forth in the company's filings with the
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