Exact Sciences Demonstrates Leadership in Cancer Innovation with New Data on Screening and Molecular Residual Disease at 2025 ASCO GI Symposium
Exact Sciences (NASDAQ: EXAS) will present 11 abstracts at the ASCO GI Symposium in January 2025, showcasing significant advances in cancer screening and diagnostics. The company's Oncodetect™ molecular residual disease (MRD) test demonstrated strong performance in Stage III colon cancer patients, with 78% sensitivity post-surgery and 91% during surveillance, along with specificities of 80% and 94% respectively.
The data reveals high adherence rates for the Cologuard® test across different demographic groups: African Americans (62%), Hispanic population (63%), Asian population (69%), and 45-49-year-olds (65%). These rates significantly exceed the generally accepted FIT adherence of 42%. New modeling data indicates that screening with triennial Cologuard results in fewer colorectal cancer cases, lower treatment costs, and higher life years gained compared to blood-based tests at perfect adherence.
Exact Sciences (NASDAQ: EXAS) presenterà 11 abstract al Symposium ASCO GI di gennaio 2025, evidenziando significativi progressi nello screening e nella diagnostica del cancro. Il test Oncodetect™ per la malattia residua molecolare (MRD) ha mostrato ottime prestazioni nei pazienti con cancro del colon in stadio III, con una sensibilità del 78% post-chirurgia e del 91% durante il monitoraggio, insieme a specificità dell'80% e del 94% rispettivamente.
I dati rivelano alti tassi di adesione per il test Cologuard® attraverso vari gruppi demografici: afroamericani (62%), popolazione ispanica (63%), popolazione asiatica (69%) e 45-49enni (65%). Questi tassi superano significativamente l'adesione generalmente accettata per il FIT del 42%. Nuovi dati di modellazione indicano che lo screening con Cologuard triennale porta a meno casi di cancro colorettale, costi di trattamento inferiori e un maggiore numero di anni di vita guadagnati rispetto ai test basati sul sangue in caso di adesione perfetta.
Exact Sciences (NASDAQ: EXAS) presentará 11 resúmenes en el Simposio ASCO GI en enero de 2025, destacando avances significativos en el tamizaje y diagnóstico del cáncer. La prueba Oncodetect™ de enfermedad residual molecular (MRD) mostró un fuerte desempeño en pacientes con cáncer colorrectal en estadio III, con una sensibilidad del 78% post-cirugía y del 91% durante la vigilancia, junto con especificidades del 80% y del 94% respectivamente.
Los datos revelan altas tasas de adherencia para la prueba Cologuard® entre diferentes grupos demográficos: afroamericanos (62%), población hispana (63%), población asiática (69%) y personas de 45 a 49 años (65%). Estas tasas superan significativamente la adherencia generalmente aceptada del FIT del 42%. Nuevos datos de modelado indican que el tamizaje con Cologuard cada tres años resulta en menos casos de cáncer colorrectal, menores costos de tratamiento y más años de vida ganados en comparación con pruebas basadas en sangre con adherencia perfecta.
Exact Sciences (NASDAQ: EXAS)는 2025년 1월 ASCO GI 심포지엄에서 암 검진 및 진단의 중요한 발전을 보여주는 11개의 초록을 발표할 예정입니다. 회사의 Oncodetect™ 분자 잔여 질환(MRD) 검사는 III기 대장암 환자에서 수술 후 78%, 감시 중 91%의 민감도를 보였으며, 각각 80% 및 94%의 특이도를 기록했습니다.
데이터는 다양한 인구 그룹에 대한 Cologuard® 검사에 대한 높은 충실도 비율을 보여줍니다: 아프리카계 미국인(62%), 히스패닉 인구(63%), 아시아계 인구(69%) 및 45-49세(65%). 이러한 비율은 일반적으로 승인된 FIT 충실도 42%를 크게 초과합니다. 새로운 모델링 데이터는 3년마다 Cologuard로 검진할 경우, 혈액 기반 검사와 비교해 대장암 발생률이 줄어들고, 치료 비용이 낮아지며, 더 많은 생명년수를 확보할 수 있음을 나타냅니다.
Exact Sciences (NASDAQ: EXAS) présentera 11 résumés lors du Symposium ASCO GI en janvier 2025, mettant en avant des avancées significatives dans le dépistage et le diagnostic du cancer. Le test Oncodetect™ de maladie résiduelle moléculaire (MRD) a démontré de solides performances chez les patients atteints d'un cancer du côlon au stade III, avec une sensibilité de 78 % après la chirurgie et de 91 % pendant le suivi, ainsi que des spécificités de 80 % et 94 % respectivement.
Les données révèlent des taux d'adhésion élevés pour le test Cologuard® parmi différents groupes démographiques : Afro-Américains (62 %), population hispanique (63 %), population asiatique (69 %) et personnes âgées de 45 à 49 ans (65 %). Ces taux dépassent de manière significative l'adhésion généralement acceptée au FIT de 42 %. De nouvelles données de modélisation indiquent que le dépistage avec Cologuard tous les trois ans entraîne moins de cas de cancer colorectale, des coûts de traitement plus bas et un plus grand nombre d'années de vie gagnées par rapport aux tests sanguins avec une adhésion parfaite.
Exact Sciences (NASDAQ: EXAS) wird im Januar 2025 auf dem ASCO GI-Symposium 11 Abstracts präsentieren, die bedeutende Fortschritte in der Krebsfrüherkennung und -diagnose zeigen. Der Oncodetect™-Test für molekularen Restkrankheit (MRD) erzielte bei Patienten mit kolorektalem Krebs im Stadium III eine Sensitivität von 78 % nach der Operation und 91 % während der Überwachung, mit Spezifitäten von 80 % und 94 % respectively.
Die Daten zeigen hohe Adhärenzraten für den Cologuard®-Test in verschiedenen demografischen Gruppen: Afroamerikaner (62 %), hispanische Bevölkerung (63 %), asiatische Bevölkerung (69 %) und 45- bis 49-Jährige (65 %). Diese Raten übersteigen die allgemein akzeptierte FIT-Adhärenz von 42 % erheblich. Neue Modellierungsdaten zeigen, dass das Screening mit triennialem Cologuard zu weniger Fällen von kolorektalem Krebs, niedrigeren Behandlungskosten und mehr Lebensjahren im Vergleich zu blutbasierten Tests bei perfekter Adhärenz führt.
- Oncodetect™ MRD test shows high sensitivity (78-91%) and specificity (80-94%) in colon cancer detection
- Cologuard® test demonstrates strong adherence rates (62-69%) across various demographic groups, exceeding FIT adherence (42%)
- Modeling data indicates superior outcomes for Cologuard vs blood-based tests in terms of cancer detection and cost-effectiveness
- None.
Insights
The latest data from Exact Sciences represents a significant advancement in two critical areas of cancer diagnostics that could strengthen the company's market position. First, the clinical validation of their Oncodetect MRD test demonstrates impressive performance metrics with
The adherence rates for Cologuard across different demographic groups (ranging from
The CRC-AIM modeling data provides compelling evidence for Cologuard's superior cost-effectiveness compared to blood-based alternatives, even assuming perfect adherence for the latter. This is particularly important as the colorectal cancer screening market faces increasing competition from blood-based tests. The ability to detect pre-cancerous lesions - a key advantage of Cologuard - appears to be a critical differentiator in both clinical and economic outcomes.
For investors, these results suggest potential for continued market share expansion and stronger reimbursement positioning. The comprehensive data across multiple demographic groups could help drive adoption in previously underserved populations, expanding the addressable market. The strong performance of Oncodetect also opens up new revenue streams in the high-growth MRD testing space, potentially diversifying the company's revenue base beyond screening.
Circulating tumor DNA (ctDNA) analysis and advanced tumor profiling in GI cancers highlight opportunities for recurrence monitoring and targeted therapy selection
Modeling analyses and real-world evidence further demonstrate the impact of Cologuard® screening through precancer detection and high-test completion rates
“The data we are presenting at ASCO GI underscore Exact Sciences’ leadership in advancing scientific innovation to drive meaningful progress in cancer detection and patient care,” said Jorge Garces, PhD, chief science officer at Exact Sciences. “These findings exemplify our steadfast commitment to rigorous research and collaboration as catalysts for improving patient outcomes.”
Among the depth and breadth of data to be presented, Exact Sciences will showcase clinical validation results for its molecular residual disease (MRD) test, Oncodetect™, including findings from the Alpha-CORRECT study in Stage III colon cancer patients. This study, which features one of the longest MRD surveillance monitoring periods to date, will be highlighted in a poster at ASCO GI this week and published in a peer-reviewed journal on January 25, 2025. The results demonstrate the test's performance, with
Four of the abstracts presented at ASCO GI confirm that the Cologuard® test and its patient navigation program are associated with strong test completion—also called adherence. The data show high adherence to the triennial test among average risk African Americans (
In addition, new modeling data from the validated CRC-AIM model shows that screening with triennial Cologuard (mt-sDNA) at published adherence rates results in fewer CRC cases, lower treatment costs, and higher life years gained than screening with blood-based tests at perfect adherence. This abstract (#88) also reinforces the importance of pre-cancer detection in CRC screening.
Abstracts Presented by Exact Sciences:
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Abstract #83, Board C20: Annual Incidence of Colorectal Cancer Among Average Risk Patients in
the United States Between 2017 And 2023 - Abstract #88, Board C25: Multi-target stool-DNA test for colorectal cancer screening and effects on health and economic outcomes compared to blood-based tests: Influence of adherence
- Abstract #89, Board C26: Comparison of screening outcomes associated with advanced precancerous lesion versus colorectal cancer sensitivity for a blood-based test: a simulation study
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Abstract #98, Board D10: Trends in Utilization of Colorectal Cancer Screening Modalities Among Average Risk Patients in
the United States From 2017 To 2023 - Abstract #99, Board D11: Multi-target Stool DNA Adherence in Average Risk African Americans from 2017-2024
- Abstract #100, Board D12: Adherence with The Multi-target Stool DNA Test in the US Hispanic Population From 2016-2024
- Abstract #101, Board D13: Adherence to Multi-target Stool DNA Test in The US Asian Population From 2017-2024
- Abstract #102, Board D14: Multi-target Stool DNA Test Adherence Among Average Risk 45-49 Year Olds from 2017-2023
- Abstract #268, Board L2: Landscape of Novel Gene Fusions in Gastrointestinal Tumors
- Abstract #302, Poster Board M10: Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: The Alpha-CORRECT study
- Abstract #781, Board K17: Comparison of mutational landscape in primary and metastatic pancreatic tumors
About the Cologuard® and Cologuard Plus™ tests
Developed in collaboration with Mayo Clinic, the Cologuard® and Cologuard Plus™ tests are first-line, non-invasive colorectal cancer (CRC) screening options for adults aged 45 or older who are at average risk for the disease. The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood in stool associated with cancer and precancer, allowing patients to complete the test at home without special preparation or time off. It is included in national screening guidelines from the American Cancer Society (2018) and the
Building on this success, the FDA-approved Cologuard Plus test raises the performance bar even further and features novel biomarkers, improved laboratory processes, and enhanced sample stability. The Cologuard Plus test is expected to reduce false positives by more than
About the Oncodetect™ test
Molecular residual disease (MRD) refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate that cancer is present. Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test may enable the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.
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.
NOTE: Exact Sciences, Cologuard, and Cologuard Plus are trademarks of Exact Sciences Corporation. Oncodetect and Oncotype are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard is only available in
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 regarding the development and commercialization of our tests and the performance of our tests in a commercial setting. 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.
References:
- Schoen RE, Diergaarde B, Young G, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: The α-CORRECT study. Presented at ASCO GI on January 21, 2025.
- Piscitello A, et al. (2020) Estimating the impact of differential adherence on the comparative effectiveness of stool-based colorectal cancer screening using the CRC-AIM microsimulation model. PLOS ONE 15(12): e0244431. https://doi.org/10.1371/journal.pone.0244431
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Media (US)
Lisa Warshaw
lwarshaw@exactsciences.com
Investors
Erik Holznecht
+1 608-800-6605
investors@exactsciences.com
Source: Exact Sciences Corp.
FAQ
What are the key performance metrics of Exact Sciences' Oncodetect™ MRD test for Stage III colon cancer?
What are the adherence rates for Cologuard® screening across different demographic groups?
How does Cologuard's adherence rate compare to FIT testing?
What advantages does triennial Cologuard screening show over blood-based tests according to the CRC-AIM model?
