MADISON, Wis.

,

Oct. 12, 2020

/PRNewswire/ — Exact Sciences Corp. (NASDAQ: EXAS) today announced the introduction of the Oncotype MAP™ Pan-Cancer Tissue test for patients with advanced, metastatic,

refractory, or

recurrent cancer. The Oncotype MAP test, previously known as PCDx, provides clinically actionable information from genomic alterations in hundreds of cancer-related genes, allowing physicians to understand a patient’s tumor profile and effectively recommend targeted therapies or clinical trials.

“Exact Sciences is pursing life-changing answers that give people the clarity to take action earlier. Our growing Precision Oncology portfolio and the addition of the Oncotype MAP test allow us to do just that for patients fighting late-stage or metastatic cancer,” said

Kevin Conroy

, chairman and CEO of Exact Sciences. “Patients with advanced cancer need answers fast, and providing them with actionable results in days, rather than weeks, is critical for improving their outcomes.”

Key attributes and differentiators of the Oncotype MAP test include:

• fast turnaround time of 3-5 business days
  
  ^1,2
  
  to guide timely treatment decisions,
• small sample requirements with as little as 3 mm
  
  ²
  
  of tissue or 2-3 slides
  
  ³
  
  ,
• highly accurate
  
  ¹
  
  and comprehensive results using next generation sequencing and immunohistochemistry, and,
• based on a study from a previous generation of the test, a significantly increased rate of progression-free survival when compared to patients who did not utilize the test (43% vs. 5%)
  
  ⁴
  
  .

The Oncotype MAP test report is easy to interpret with NCCN

^®

Compendium-based recommendations, along with potential evidence-based therapies and clinical trials. The report is currently tailored to support clinical decision making by showing actionable biomarkers associated with more than 100 evidence-based therapies, over 45 combination therapies, and more than 650 active clinical trial associations. By delivering insights into targeted therapy options, the Oncotype MAP test is designed to address the needs of more than 500,000 patients who face advanced cancer each year in

the United States


⁵

.

“The systemic treatment of patients with advanced or metastatic cancer is challenging,” said

Rick Baehner

, MD, chief medical officer of Precision Oncology at Exact Sciences. “Oncotype MAP is a tissue-based assay which delivers results regarding the underlying biology of a patient’s cancer and provides therapeutic and clinical trial options. Genomic results guide clinicians to individualize and optimize oncology therapy by targeting patient tumor biology with the most effective therapies.”

The Oncotype MAP test is currently available for physicians in the U.S. to order at

www.OncotypeMAP.com

. Medicare covers the Oncotype MAP test for qualifying members and commercial coverage varies by insurance plan and patient benefit level.

About the Oncotype MAP

^™

Pan-Cancer Tissue Test


The Oncotype MAP

^TM

Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With minimal tissue requirements, the Oncotype MAP test utilizes next generation sequencing (NGS) and immunohistochemistry (IHC) to provide in-depth insights into genomic alterations in hundreds of cancer-related genes, including tumor mutations, copy number variants, fusions, tumor mutation burden (TMB), microsatellite instability, and protein expression. Providing results in 3-5 business days

^1,2

, the Oncotype MAP test report is currently tailored to support clinical decision making with actionable biomarkers associated with more than 100 evidence-based therapies, over 45 combination therapies, and more than 650 active clinical trial associations, to deliver treatment options for a breadth of solid tumor types. The Oncotype MAP test is performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP). To learn more about the Oncotype MAP test, visit

www.OncotypeMAP.com

.

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: Oncotype DX, Oncotype MAP and Oncotype MAP Pan-Cancer Tissue are trademarks of Genomic Health, Inc. Cologuard is a trademark of Exact Sciences Corporation.

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 our actual results and financial condition 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 and maintain turnaround times’ 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 business acquisitions 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 acquired businesses 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

Data on file, in-house assay optimization protected by trade-secret/patent regulations.


²

Turnaround time is based on sample receipt.


³

Morris S, Subramanian J, Gel E, Runger G, Thompson E, Mallery D, et al. Performance of next-generation sequencing on small tumor specimens and/or low tumor content samples using a commercially available platform. PLoS ONE. (2018); 13(4): e0196556.

https://doi.org/

10.1371/journal.pone.0196556.


⁴

Radovich, M, et al. Clinical benefit of a precision medicine-based approach for guiding treatment of refractory cancers. Oncotarget. (2016); 7(35): 56491-56500.

https://doi.org/

10.18632/oncotarget.10606.


⁵

L.E.K. Analysis of NIH SEER Program (2016). ASCO 2020 Poster #184919 from Roche

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