Exact Sciences
Cologuard Approved for Use by Americans Ages 45 to 49 Page 3 of 5
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of some of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal 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.
About Cologuard
Cologuard was first approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and as a recommended option for adults over the age of 50 by the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016).
Cologuard is indicated to screen adults of either sex, 45 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals, including those with a history of colorectal cancer and adenomas, a family history of colorectal cancer, IBD, or certain hereditary syndromes. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. The clinical validation studies were conducted in patients over 50 years of age. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.
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, 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 and marketing 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
October Is Health Literacy Month
This October is health literacy month where we celebrate 20 years of promoting health information. Whether you have rarely used your health insurance in the past or your family hits […]
Financial Assistance for Colorectal Cancer Screenings and Treatments
If you have recently had a colorectal cancer diagnosis or need a screening, learn more about financial assistance programs that may alleviate some of your medical bills. The Blue Hope Financial Assistance program helps low-income individuals reduce the burden of testing and treatment costs.
The Blue Hope Financial Assistance program offers low-cost screenings for colonoscopies and FIT tests, $300 stipends to assist with screenings or $200 to help with colorectal cancer treatment costs.
To qualify for a low-cost colonoscopy, you must be uninsured or underinsured and have a total income below 200% of the federal poverty guidelines. To be eligible for a stipend, you must be uninsured or underinsured and have a total household income of less than $75,000. If you have received assistance from the program in the past, you may not apply again.
The program does not exclude applicants based on age or genetic factors, so encourage your loved ones to apply if they qualify for the Blue Hope Financial Assistance program.
Learn more about the Blue Hope Financial Assistance program and apply at the Colon Cancer Alliance. Discover more resources on financial assistance and get the tools and support you need online.
Additional resources:
https://www.cancercare.org/financial_assistance
https://www.panfoundation.org/index.php/en/patients/assistance-programs/colorectal-cancer
https://www.ccalliance.org/patient-family-support/financial-assistance-programs
https://www.cancer.org/content/cancer/en/treatment/support-programs-and-services/patient-lodging/hope-lodge.html
https://www.cancerandcareers.org/en
https://www.allysonwhitney.org/grants/
https://www.cancersupportcommunity.org/resources
https://www.patientadvocate.org/explore-our-resources/national-financial-resource-directory/
COLOGUARD® GAINS FDA APPROVAL FOR USE IN YOUNGER AMERICANS, AGES 45 TO 49
Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.
MADISON, Wis. –September 23, 2019 (NASDAQ: EXAS) – Exact Sciences Corp. announced today that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older. The decision comes at a critical time when the incidence of colorectal cancer is on the rise among American adults under the age of 50.i
Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.i Among these cases, more than half were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low. About one out of 10 people with stage IV colorectal cancer survive beyond five years.ii,iii
The American Cancer Society (ACS) responded to the growing trend of colorectal cancer in younger patients in May 2018 when it updated its colorectal cancer screening guidelines to include people between the ages of 45 to 49.i The prior ACS recommendation called for screening to begin at age 50.vii
Colorectal cancer is considered the most preventable, yet least prevented form of canceriv and is the second deadliest cancer in the U.S.v Regular screening is crucial because colorectal cancer is more treatable when detected in its earlier stages.v
The label expansion, or broadening of the population for whom Cologuard is FDA- approved, provides a new, sensitive, at-home stool-based screening choice for the approximately 19 million average-risk people in the U.S. ages 45 to 49.vi
“About three million people have been screened for colorectal cancer with Cologuard, with nearly half of those surveyed saying they were previously unscreened. With the FDA now approving the use of Cologuard for this vulnerable 45-49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people,” said Kevin Conroy, chairman and CEO of Exact Sciences.
Backed by strong science and robust clinical research in collaboration with Mayo Clinic, Cologuard is a stool DNA-based colorectal cancer screening test for average-
(more)
Exact Sciences
Cologuard Approved for Use by Americans Ages 45 to 49 Page 2 of 5
risk individuals. Cologuard uses a biomarker panel which analyzes a person’s stoolsample for 10 DNA markers, as well as blood in the stool (hemoglobin).
“The alarming rise in incidences of colorectal cancer for those under 50 is creating a sense of urgency,” said Anjee Davis, President of Fight Colorectal Cancer. “To tacklethe need for increased awareness and screening across the country, we must work together with advocacy groups, industry innovators, insurance companies and health care providers. There is a need to educate the public about colorectal cancer screening and the array of reliable screening options. Expanding the screening age to 45 for Cologuard provides an additional tool to reach the unscreenedpopulations.”
In an effort to combat the colorectal cancer screening gap, Exact Sciences designed a one-of-a-kind, nationwide user-navigation system that provides 24/7 phone and online support to help people through the process of collecting and returning their samples. This approach combines multiple industry best practices to offer a vital tool in the collective efforts to increase colorectal cancer screening.
“The medical and scientific communities agree that rising rates of colorectal cancer in younger adults must be addressed, and we support efforts to gather evidence on the impact of screening in younger populations,” said Paul Limburg, MD, MPH,AGAF, Chief Medical Officer of Exact Sciences and Mayo Clinic gastroenterologist. “As research progresses, we must offer screening options to people that may already have or will develop colorectal cancer and pre-cancers, aiming to increase screening rates and halt the rise of colorectal cancer in younger Americans.”
Exact Sciences is committed to working across the health care delivery system to ensure those seeking an at-home, noninvasive screening test have access to all options and is actively working with payer partners to expand coverage to include this critical screening population.
Cologuard is available to appropriate patients through their health care provider. For more information, visit www.CologuardTest.com or call 1-844-870-8870.
###
Cara Connelly, cconnelly@exactsciences.com, 614-302-5622
Media Contact: Investor Contact:
Megan Jones, meganjones@exactsciences.com, 608-535-8815About Exact Sciences Corp.
Exact Sciences
Cologuard Approved for Use by Americans Ages 45 to 49 Page 3 of 5
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of some of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal 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.
About Cologuard
Cologuard was first approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and as a recommended option for adults over the age of 50 by the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016).
Cologuard is indicated to screen adults of either sex, 45 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals, including those with a history of colorectal cancer and adenomas, a family history of colorectal cancer, IBD, or certain hereditary syndromes. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. The clinical validation studies were conducted in patients over 50 years of age. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.
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, 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 and marketing 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
Exact Sciences
Cologuard Approved for Use by Americans Ages 45 to 49 Page 4 of 5
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. Our actual results and financial condition 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: 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 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 from other cancer screening and diagnostic 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 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; our ability to effectively utilize strategic partnerships, such as 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; 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.
Exact Sciences
Cologuard Approved for Use by Americans Ages 45 to 49 Page 5 of 5
i Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281.
ii Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;0:1-8.
iii Lansdorp-Vogelaar I, v Ballegooijen M, Zauber AG et al. Effect of Rising Chemotherapy Costs
on the Cost Savings of Colorectal Cancer Screening. J Natl Cancer Inst 2009;101:1412-1422.iv
v
vi United States Census Bureau. www.census.gov. Accessed September 10, 2019.
vii Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening. CA: A Cancer Journal for Clinicians, 67: 100-121.
In Loving Memory of Dr. Thomas K. Weber
September Is Childhood Cancer Awareness Month
Colorectal cancer, one of the most deadliest cancers in the United States, affects a variety of ages. This September, honor Childhood Cancer Awareness Month by learning more about early age onset cancer and how it affects those around you.
What Is Early Age Onset Colorectal Cancer?
Early age onset cancer happens when anyone under 50-years-old develops colorectal cancer, including children. Even though diagnoses over the age of 50-years-old are decreasing, those under 50-years-old are seeing higher diagnosis rates. While it is rare for children to get this deadly cancer, it can occur based on genetics and/or lifestyle choices.
Can Children Get Early Age Onset Colorectal Cancer?
According to St. Jude Children’s Research Hospital, less than 100 children in the United States will develop colon carcinoma this year. While colorectal cancer may be rare in children, it is still possible and genetic screening can help your loved ones catch the cancer earlier. Learn more about early age onset cancer on our blog.
What Can I Do to Support Those With Childhood Cancer?
You can support those with childhood colorectal cancer in many ways. Getting involved with the Colon Cancer Foundation is an easy way to provide support for those with colorectal cancer. We have opportunities for everyone regardless of your income level or time commitment. Learn how to get involved today on our blog.
African Americans Have a Greater Risk for Colorectal Cancer
When it comes to colorectal cancer, various factors affect your risk for developing this deadly disease, including your ethnicity. African Americans are more likely to develop colorectal cancer at a younger age than Caucasian or Hispanics.
Why are African Americans More Likely to Develop Colorectal Cancer?
Multiple factors affect one’s likelihood of developing colorectal cancer. According to the National Cancer Institute, African Americans are more likely to have a predisposition to colorectal cancer due to genetic makeup. Mutations in the KRAS gene, which affect a cell’s ability to repair errors in DNA replication, are more abundant in African Americans.
Are African-Americans Less Likely to Get Screened for Colorectal Cancer?
African Americans are less likely to get screened for colorectal cancer, which is attributed to an increase in colorectal cancer mortality rates. According to recent research, medical mistrust may contribute to a decrease in screenings for African Americans.
How Can I Convince My Friends to Get Screened?
Ask your friends if they are abiding by the recommended screening guidelines. The American Cancer Society recommends starting screenings at 45-year-old for those with normal risk. Learn more about colorectal cancer screenings and get tested today.
Fifth Annual Early Age Onset Colorectal Cancer Summit Videos
Did you catch our recap on the Fifth Annual Early Age Onset Colorectal Cancer Summit? We are excited to share video footage from our groundbreaking conference on preventing colorectal cancer. If you were unable to attend, please watch these short recaps on various sessions throughout the summit.
Palliative Care
https://www.youtube.com/watch?v=pURzAM80gMo
In session six, Sarah DeBord, a patient, discusses building her own cancer support system and her familiarity with palliative care, including lobbying for more support. She uses a specific analogy of an onion to describe the layers of care that a patient requires.
Cancer Susceptibility Gene Mutations in Individuals
https://www.youtube.com/watch?v=xyO1_lMk2K4
Dr. Matthew B. Yurgelun shared the shift in mentality in how physicians look at hereditary colorectal cancer. Dr. Yurgelun shares how next-generation sequencing technologies allow for rapid assessment of genes in a way that is deeper than researchers could understand in the past.
Framing the Conversation
https://www.youtube.com/watch?v=zsHZP8_bMCE
One of our favorite, but most heartbreaking, moments of the conference included various attendees sharing their personal stories with colorectal cancer. These stories show the importance of getting tested and staying educated on the dangers of colon cancer.
Discover the rest of our videos from the summit on our YouTube page and learn more about the summit on our website.
Create a Facebook Fundraiser for the Colon Cancer Foundation for Your Birthday
If your birthday is coming up, consider creating a Facebook Fundraiser for the Colon Cancer Foundation for your birthday. It’s a quick and simple way to show your support for survivors and patients of one of cancer’s deadliest diseases. Learn more with these quick steps:
Step 1: Visit Facebook Fundraisers
Visit Facebook Fundraisers to start the process of setting up a fundraiser.
Step 2: Find the Colon Cancer Foundation
Type in Colon Cancer Foundation when prompted to find a nonprofit. Since we are a US 501(c)(3), your donations will be tax-deductible. However, we encourage reaching out to a tax professional if you have more questions.
Step 3: Decide how much you would like to raise for your fundraiser.
No matter what amount you decide, all money will go directly to the Colon Cancer Foundation. Facebook does not charge fees for donations made to nonprofits. Any money that is donated will help support our mission to support colorectal cancer survivors and patients while also supporting innovative research to fight this deadly disease.
Step 4: Encourage your friends to donate!
Friends may choose to donate publically or privately. However, they may need encouragement from you. Make sure to share status updates and tell your friends why the fundraiser is important to you.
The CCF is fortunate to have raised over $100,000 this year in Facebook Fundraisers! Small actions together can make great change, so start a fundraiser today to help support the CCF. Every penny helps when it comes to eradicating colorectal cancer and we can’t do it without you.
What Is Palliative Care?
Palliative Care is a trending topic in many cancer circles right now and is making headway as general medical care for those with colorectal or colon cancer. Palliative care is a specific treatment for those suffering from severe illness with the hopes of providing relief from symptoms. While palliative care is still becoming mainstream for those who are suffering from colorectal cancer, many patients who are struggling with the disease are finding relief that is aiding their fight against cancer.
How was Palliative Care Created?
According to the Center for Palliative Care at the Harvard Medical School, palliative care started in the United Kingdom in the 1960s. Medical professionals aimed to ease the pain and suffering of terminal cancer patients who had run out of options. The field developed, however, to treat those with non-terminal illnesses to relieve the suffering of any patient, regardless of disease.
How Does Palliative Care Help Colorectal Cancer Patients?
Many colorectal cancer patients face day-to-day issues that stem from not only their cancer but necessary treatment to eradicate the disease as well. Palliative care can treat symptoms from colorectal cancer, such as discomfort in bowel impactions or issues in the large intestine. Blockages can irritate the body and require surgery, but palliative care can change a patient’s quality of life to prevent discomfort.
Where Can I Get More Information About Palliative Care?
If you want to learn more about palliative care, contact your family physician doctor to discuss treatment options. Improving the quality of life for colorectal cancer patients is essential to aide their fight against the deadly disease. Our Fifth Annual Early Age Onset Colorectal Cancer Summit discussed the latest trends and innovations regarding palliative care last May. The Colon Cancer Foundation is proud to support physicians and researchers who are actively tackling palliative care and other vital topics that affect those with colorectal cancer.
For more information on palliative care, please reach out to us at info@coloncancerchallenge.org or (914) 305-6674.
Fifth Annual Early Age Onset Colorectal Cancer Summit Recap
We are proud to announce our Fifth Annual Early Age Onset Colorectal Cancer Summit was a success in bringing together the nation’s experts on early age onset colorectal cancer last month. The event, held at The Times Center in New York City, focused on performing a knowledge GAP analysis and building a strategic “action plan” to reduce early age onset colorectal cancer incidence & mortality.
At the summit, leading clinicians, scientists and early age onset colorectal cancer survivors shared their experience with colorectal cancer treatment. Lectures, workshops and panel discussions provided innovative approaches to palliative care and featured world-renowned speakers from leading academic medical centers. Popular sessions ranged from “Identifying the Key Elements of a Center for Early Age Onset Colorectal Cancer – Panel Discussion” to “Cancer Susceptibility Gene Mutations in Individuals with Colorectal Cancer.”
One of this year’s highlights included a “Research in Progress” segment, where participants learned about NCI funded and planned early age onset colorectal research projects from across the world. Participants learned more about recent research and evidence-based framework for reducing risk in those susceptible to early age onset colorectal cancer.
Our poster presentation at the fifth annual summit showcased research or programs that have the potential to impact how we treat early age onset colorectal cancer. “Does the Impact of Tumor Sideedness Differ for Young-Onset Vs. Later-Onset Colorectal Cancer” by Lucas D. Lee, MD, at The University of Texas MD Anderson Cancer Center in Houston, Texas received first place for the abstract awards. For a complete list of abstracts, please read more in the Fifth Annual Early Age Onset Colorectal Cancer Summit agenda.
ABSTRACT AWARDS
FIRST PLACE
DOES THE IMPACT OF TUMOR SIDEDNESS DIFFER FOR YOUNG-ONSET VS. LATER-ONSET COLORECTAL CANCER?
Lucas D. Lee, MD
The University of Texas MD Anderson Cancer Center, Houston, Texas
SECOND PLACE
THE PSYCHOSOCIAL AND FINANCIAL BURDEN ON CAREGIVERS OF YOUNG-ONSET COLORECTAL CANCER PATIENTS
Kimberley Newcomer, BS, CPPN Colorectal Cancer Alliance, Washington, DC
THIRD PLACE
CLINICOPATHOLOGICAL, FAMILIAL, AND MOLECULAR CHARACTERIZATION OF RECTAL CANCER WITHIN EARLY- ONSET COLORECTAL CANCER
José Perea, MD, PhD
Fundación Jiménez Díaz University Hospital and Health Research Institute, Early-Onset Colorectal Cancer-UAM Observatory, Madrid, Spain
Thank you to all of our sponsors who made the event possible. If you are interested in sponsoring any Colorectal Cancer Foundation events in the future, please contact us at 914.305.6675 to learn more.