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Exact Sciences (EXAS) Enrolls First Patient in Pivotal MCED Study
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Exact Sciences Corporation (EXAS - Free Report) recently enrolled the first patient in its pivotal Multi-Cancer Early Detection (“MCED”) Falcon Registry Real-World Evidence (“RWE”) study. The Texas-based not-for-profit health system, Baylor Scott & White, will serve as the principal site for the study, with Endeavor Health in Chicago set to begin enrolling patients this fall.
The multi-site study will register up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over five years. In addition, the FDA recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry.
Relevance of the Study
Cancer remains the second leading cause of death in the United States, with more than 2 million new cases and approximately 611,000 deaths projected for 2024. Per the EXAS representative, cancers frequently remain undetected until symptoms appear, leading to diagnoses at advanced, less treatable stages. While early detection through screening improves outcomes, nearly two-thirds of cancer cases and deaths occur from cancers that do not have recommended screening options. In light of these, EXAS is committed to advancing an MCED test, which holds substantial potential to make an impact on the burden of cancer.
Image Source: Zacks Investment Research
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. It is presently available to patients who have consented and enrolled in the Falcon Registry study and have not been cleared or approved by the FDA or other notified regulatory authorities. Exact Sciences Laboratories developed and validated the test based on the College of American Pathologists and Clinical Laboratory Improvement Amendments regulations.
The findings from the MCED Falcon Registry RWE research will be essential to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers and guideline bodies.
More on the Falcon Registry Study
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 aged 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.
Both 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. The collaboration marks a crucial step forward for Exact Sciences and a valuable opportunity to help transform cancer care.
Industry Prospects
Per a Grand View Research Report, the global MCED market is valued at $993 million (estimated) in 2023 and is likely to witness a CAGR of 16.6% by 2030. The rising prevalence of multiple cancers and the demand for early detection methods are fueling the market growth.
Notable Developments
The second quarter of 2024 marked a hallmark period for Exact Sciences’ pipeline, with significant advancements made in its most impactful programs — colon cancer screening, molecular residual disease testing and multi-cancer screening. Cologuard Plus is anticipated to become the most non-invasive way to screen for colon cancer, having earlier met all the pivotal BLUE-C study endpoints. The company’s blood-based colon cancer screening test, evaluated more than 3,000 samples, is expected to perform comparably to other tests and meet the Medicare requirements.
Additionally, the Oncodetect MRD (minimal residual disease) test generated impressive study results, proving highly accurate at detecting residual disease in colon cancer patients. These findings will be published in a scientific journal later this year, with the launch and reimbursement of the test planned for 2025.
Price Performance
In the past year, shares of EXAS have dropped 29.4% compared with the industry’s decline of 1%.
Zacks Rank and Other Key Picks
Exact Sciences currently carries a Zacks Rank #2 (Buy).
Masimo shares have risen 11.6% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 56.5% in the past year compared with the industry’s rise of 10.9%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.
Estimates for Quest Diagnostics’ 2024 earnings have moved 0.3% north to $8.88 in the past 30 days. Shares of the company have increased 14.7% in the past year compared to the industry’s 19.5% growth.
DGX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.3%. In the last reported quarter, it delivered an earnings surprise of 1.7%.
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Exact Sciences (EXAS) Enrolls First Patient in Pivotal MCED Study
Exact Sciences Corporation (EXAS - Free Report) recently enrolled the first patient in its pivotal Multi-Cancer Early Detection (“MCED”) Falcon Registry Real-World Evidence (“RWE”) study. The Texas-based not-for-profit health system, Baylor Scott & White, will serve as the principal site for the study, with Endeavor Health in Chicago set to begin enrolling patients this fall.
The multi-site study will register up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over five years. In addition, the FDA recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry.
Relevance of the Study
Cancer remains the second leading cause of death in the United States, with more than 2 million new cases and approximately 611,000 deaths projected for 2024. Per the EXAS representative, cancers frequently remain undetected until symptoms appear, leading to diagnoses at advanced, less treatable stages. While early detection through screening improves outcomes, nearly two-thirds of cancer cases and deaths occur from cancers that do not have recommended screening options. In light of these, EXAS is committed to advancing an MCED test, which holds substantial potential to make an impact on the burden of cancer.
Image Source: Zacks Investment Research
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. It is presently available to patients who have consented and enrolled in the Falcon Registry study and have not been cleared or approved by the FDA or other notified regulatory authorities. Exact Sciences Laboratories developed and validated the test based on the College of American Pathologists and Clinical Laboratory Improvement Amendments regulations.
The findings from the MCED Falcon Registry RWE research will be essential to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers and guideline bodies.
More on the Falcon Registry Study
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 aged 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.
Both 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. The collaboration marks a crucial step forward for Exact Sciences and a valuable opportunity to help transform cancer care.
Industry Prospects
Per a Grand View Research Report, the global MCED market is valued at $993 million (estimated) in 2023 and is likely to witness a CAGR of 16.6% by 2030. The rising prevalence of multiple cancers and the demand for early detection methods are fueling the market growth.
Notable Developments
The second quarter of 2024 marked a hallmark period for Exact Sciences’ pipeline, with significant advancements made in its most impactful programs — colon cancer screening, molecular residual disease testing and multi-cancer screening. Cologuard Plus is anticipated to become the most non-invasive way to screen for colon cancer, having earlier met all the pivotal BLUE-C study endpoints. The company’s blood-based colon cancer screening test, evaluated more than 3,000 samples, is expected to perform comparably to other tests and meet the Medicare requirements.
Additionally, the Oncodetect MRD (minimal residual disease) test generated impressive study results, proving highly accurate at detecting residual disease in colon cancer patients. These findings will be published in a scientific journal later this year, with the launch and reimbursement of the test planned for 2025.
Price Performance
In the past year, shares of EXAS have dropped 29.4% compared with the industry’s decline of 1%.
Zacks Rank and Other Key Picks
Exact Sciences currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are Masimo (MASI - Free Report) , Boston Scientific (BSX - Free Report) and Quest Diagnostics (DGX - Free Report) . While Masimo sports a Zacks Rank #1 (Strong Buy) at present, Boston Scientific and Quest Diagnostics each carry a Zacks Rank #2. You can see the complete list of today’s Zacks Rank #1 stocks here.
Masimo shares have risen 11.6% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 56.5% in the past year compared with the industry’s rise of 10.9%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.
Estimates for Quest Diagnostics’ 2024 earnings have moved 0.3% north to $8.88 in the past 30 days. Shares of the company have increased 14.7% in the past year compared to the industry’s 19.5% growth.
DGX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.3%. In the last reported quarter, it delivered an earnings surprise of 1.7%.