Exact Sciences Announces First Patient Enrolled in its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence Study

Rhea-AI Summary

Exact Sciences Corp. (Nasdaq: EXAS) has initiated its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence study, enrolling the first patient at Baylor Scott & White Health in Texas. The study aims to enroll up to 25,000 patients aged 50-80 with no cancer history, evaluating the clinical performance and impact of MCED testing over a five-year period. Endeavor Health in Illinois will also participate, starting enrollments this fall.

The study, authorized by the FDA under an investigational device exemption, will provide insights for developing Exact Sciences' future MCED test. Participants will undergo annual MCED testing for three years, followed by two years of follow-up data collection. The test combines two high-performing biomarker classes to detect cancer early, potentially addressing the gap in existing screening programs and aligning with the U.S. government's Cancer Moonshot initiative to reduce cancer mortality by 50% over 25 years.

Positive

• FDA authorization of investigational device exemption for Exact Sciences' MCED test
• Enrollment of first patient in the Falcon Registry study, aiming for 25,000 participants
• Collaboration with major health systems Baylor Scott & White and Endeavor Health
• Potential to detect aggressive cancers and those lacking current standard screening
• Alignment with U.S. government's Cancer Moonshot initiative

Negative

• MCED test not yet cleared or approved by FDA or other regulatory authorities
• Extended five-year study period before potential commercialization

Insights

Medical Research Analyst

Exact Sciences' enrollment of the first patient in their MCED Falcon Registry study marks a significant milestone in cancer screening research. This large-scale study, aiming to enroll up to 25,000 patients, will provide important real-world evidence on the performance and impact of multi-cancer early detection testing.

The study's design, including a comparator cohort of 50,000 patients, will offer robust data on the effectiveness of MCED testing compared to standard care. This approach could potentially revolutionize cancer screening by addressing cancers that currently lack recommended screening options.

However, it's important to note that the five-year duration of the study means that definitive results and potential regulatory approvals are still years away. Investors should view this as a long-term investment in Exact Sciences' future product pipeline rather than an immediate revenue driver.

Oncology Doctor

The initiation of the Falcon Registry study is a pivotal step in addressing the critical need for earlier cancer detection. The study's focus on patients aged 50-80 aligns with the highest-risk population for many cancers, potentially maximizing the impact of MCED testing.

The test's ability to detect aggressive cancers and those without current screening options is particularly promising. This could lead to earlier interventions and potentially improved patient outcomes. However, it's important to consider potential challenges such as false positives and the psychological impact of testing, which this study aims to assess.

The collaboration with major health systems like Baylor Scott & White and Endeavor Health adds credibility to the study and ensures a diverse patient population, enhancing the generalizability of results.

Financial Analyst

Exact Sciences' investment in the Falcon Registry study demonstrates its commitment to innovation in the cancer screening market. This positions the company to potentially capture a significant share of the growing MCED market, estimated to reach $25 billion by 2030.

The study's design, including a large patient cohort and extended follow-up, suggests a substantial financial investment. While this may impact short-term profitability, it could lead to long-term revenue growth if the MCED test proves successful and gains regulatory approval.

Investors should note that the study's five-year timeline means any potential commercial benefits are not immediate. However, positive interim results could drive investor confidence and potentially impact stock performance. The company's current strong position in cancer diagnostics provides a solid foundation for this new venture.

Primary study sites Baylor Scott & White Health in Texas and Endeavor Health in Illinois aim to enroll up to 25,000 patients from diverse backgrounds, assessing the impact of MCED testing on clinical care

Falcon Registry study is another step in Exact Sciences’ rigorous approach to develop its future multi-biomarker class blood-based MCED test

MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas. The multi-site study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Endeavor Health, a Chicago-area health system serving more than 1.4 million patients, will start enrolling patients this fall. The U.S. Food and Drug Administration (FDA) recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry. This study will provide valuable insight to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers, and guideline bodies.

“Exact Sciences is dedicated to advancing an MCED test, as it offers a highly promising way to make an impact on the burden of cancer,” said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. “Too often, cancers go undetected until symptoms appear, resulting in diagnoses at advanced, less treatable stages. Early detection through screening improves outcomes, yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options.¹ Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care.”

To better understand the impact of MCED testing on patient care, the study will use a registry approach, tracking patient data over time to evaluate outcomes and improve future treatments. Up to 25,000 patients ages 50-80 with no history of cancer will participate in annual MCED testing for three years and two additional years of follow-up data collection. Data will also be collected for a comparator cohort of up to 50,000 patients, demographically and clinically similar to the study cohort but receiving standard care without the MCED test. The Exact Sciences MCED test features two high-performing biomarker classes known for their ability to identify cancer early, offering sensitivity and specificity that can detect aggressive cancers and those lacking current standard of care screening.²

“With this important work, we aim to intercept cancer earlier than ever before,” said Ronan Kelly, M.D., principal investigator of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is the director of oncology, Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center — Dallas, and chief of oncology, North Texas Division, Baylor Scott & White Health. “We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the U.S. government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programs.”

Cancer remains the second leading cause of death in the United States, with over 2 million new cases and approximately 611,000 deaths projected for 2024.³ Advancing early detection through innovative approaches like MCED testing has never been more critical. Baylor Scott & White and Endeavor Health, located in distinct parts of the country and serving a diverse range of communities, will help reach a broad representative group of Americans and provide insights on the potential benefits of early detection across diverse populations.

“Implementing MCED testing and advancing preventative genomics are crucial steps in addressing the ‘last mile’ problem in health care,” said Peter Hulick, M.D., the Janardan D. Khandekar, M.D., chair of personalized medicine and the director of the Mark R. Neaman Center for Personalized Medicine at Endeavor Health. “The Falcon Registry is a pivotal research study to meet the real-world challenges of implementation and aligns with the broader vision of the Davis Family Center for Preventive Genomics at Endeavor Health, which is to assist patients, their families, and caregivers in making better-informed decisions about early diagnosis, prevention strategies, and personalized treatment options.”

The Exact Sciences MCED test is available to patients who have consented and enrolled in the Falcon Registry study. It has not been cleared or approved by the U.S. Food and Drug Administration or other notified regulatory authority. The test was developed and its performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

About Baylor Scott & White Health

As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit BSWHealth.com.

About Endeavor Health

Endeavor Health℠ is a Chicagoland-based integrated health system driven by the mission to help everyone in their communities be their best. Illinois' third-largest health system and third-largest medical group serves an area of more than 4.2 million residents across seven northeast Illinois counties. More than 27,000 team members and more than 7,100 physician and advance practice provider partners deliver seamless access to personalized, pioneering, world-class patient care across more than 300 ambulatory locations and nine hospitals, including eight Magnet-recognized acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights), Skokie and Swedish (Chicago) and Linden Oak Behavioral Health Hospital (Naperville). For more information, visit www.endeavorhealth.org.

NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype is a trademark of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statement

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. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the size and effectiveness of the real-world evidence study discussed in this news release; the development and commercialization of the multi-cancer early detection (MCED) test; the performance characteristics and health care benefits of the MCED test in a commercial setting; and the timing and anticipated results of FDA or any other national regulatory authority submission. 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.

¹ Siegel RL, et al. Cancer statistics, 2024. CA Cancer J Clin. 2024;74:12–49.
² Gainhullin V., et. al. Abstract #LB100/11, AACR 2024.
³ Siegel, R. L., Giaquintion, A,N.,& Jemal, A (2024). Cancer statistics, 2024. CA: a cancer journal for clinicians, 74(1), 12–48. https://doi.org/10.3322/caac.21820

View source version on businesswire.com: https://www.businesswire.com/news/home/20240820448601/en/

Exact Sciences

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

Investor Contact: Erik Holznecht, investorrelations@exactsciences.com, 608-800-6605

Baylor Scott & White Media Contact: Julie Smith, Julie.Smith@BSWHealth.org, 940-765-7560

Endeavor Health Media Contact: Keith Hartenberger, keith.hartenberger@eehealth.org, (630) 527-3929

Source: Exact Sciences Corp.

FAQ

What is the purpose of Exact Sciences' MCED Falcon Registry study?

The study aims to evaluate the clinical performance, patient and provider experience, and psychological impact of Multi-Cancer Early Detection (MCED) testing over a five-year period, enrolling up to 25,000 patients.

How many patients will be enrolled in Exact Sciences' MCED Falcon Registry study?

The study aims to enroll up to 25,000 patients aged 50-80 with no history of cancer for MCED testing, and up to 50,000 patients in a comparator cohort receiving standard care without the MCED test.

Which health systems are participating in Exact Sciences' (EXAS) MCED Falcon Registry study?

The primary study sites are Baylor Scott & White Health in Texas and Endeavor Health in Illinois.

Has the FDA approved Exact Sciences' (EXAS) MCED test?

The FDA has authorized an investigational device exemption (IDE) for the MCED test, allowing its use in the Falcon Registry study. However, the test has not been cleared or approved by the FDA for general use.

How long will patients be followed in Exact Sciences' MCED Falcon Registry study?

Patients will participate in annual MCED testing for three years, followed by two additional years of follow-up data collection, for a total study period of five years.