- New data and society guidelines support value of Oncotype DX Breast Recurrence Score® test in guiding neoadjuvant treatment decisions for newly diagnosed patients - Mayo Clinic collaboration yielding new data and insights on some of the deadliest cancers
| MADISON, Wis., May 29, 2020 /PRNewswire/ -- EXACT Sciences Corporation. (NASDAQ: EXAS) today announced it is presenting new data at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program. These data further demonstrate the clinical value of the Oncotype DX Breast Recurrence Score® test and exemplify the research progress made by Exact Sciences’ Mayo Clinic collaboration toward smarter solutions across the cancer continuum.
Three studies of the Oncotype DX Breast Recurrence Score® test presented at ASCO20 highlight the value that the Oncotype DX® test can provide by personalizing and improving neoadjuvant treatment decisions (i.e., prior to surgery) in women with hormone receptor positive, HER2-negative breast cancer. The new data at ASCO20 add to existing evidence1,2,3 and reinforce the value of the Oncotype DX test in light of recent COVID-19 pandemic recommendations.4,5 “As health systems across the world respond to the COVID-19 pandemic, both cancer screenings and elective surgeries are being postponed,” said Dr. Anthony Lucci, professor of Breast Surgical Oncology at MD Anderson Cancer Center. “Based on the new data presented at ASCO20, the Oncotype DX test identified women with a low likelihood of responding to neoadjuvant chemotherapy, who may benefit from alternative approaches while awaiting surgery, such as neoadjuvant endocrine therapy at home. This approach could overcome some of the unique challenges we and our patients are currently facing during this public health crisis.” Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score in young women with estrogen receptor-positive early breast cancer 21-gene Recurrence Score assay as a predictor of pathological response in neoadjuvant chemotherapy administration for ER-positive/HER2-negative early-stage breast cancer Prediction of response to neoadjuvant hormonal therapy (NAHT) using upfront Oncotype DX Breast Recurrence Score (RS): results from the SAFIA phase III trial Additional Abstracts Highlight Progress in Research and Development Through a longstanding collaboration, researchers at Exact Sciences and Mayo Clinic continue to identify biomarkers associated with some of the deadliest forms of cancer. Abstracts accepted for presentation at ASCO20, including promising results in five different cancer types, are highlighted below. Algorithm for blood-based panel of methylated DNA and protein markers to detect early-stage hepatocellular carcinoma (HCC) with high specificity Molecular detection of pancreatic neuroendocrine tumors using methylated DNA markers: discovery and tissue validation Novel methylated DNA markers in plasma detect distant recurrence of colorectal cancer Methylated DNA markers for plasma detection of ovarian cancer: discovery, validation, and clinical feasibility Methylated DNA marker panel for metastatic melanoma: discovery and tissue validation ASCO20 will be conducted May 29-31, 2020. About Oncotype DX About Exact Sciences Corp. NOTE: Oncotype, Oncotype DX, Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences is a trademark or registered trademark of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners. Forward-Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Genomic Health’s operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. 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. 1 Iwata H, et al. Breast Can Res Treat. 2019.
SOURCE EXACT SCIENCES CORP | ||||||||||||||
Company Codes: NASDAQ-SMALL:EXAS |
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