New Evidence Validates Oncodetect's™ Ability to Detect Molecular Residual Disease and Predict Recurrence in Colorectal Cancer Patients
Exact Sciences (NASDAQ: EXAS) revealed clinical validation data for its Oncodetect MRD test at ASCO GI 2025. The Alpha-CORRECT study demonstrated the test's effectiveness in detecting molecular residual disease in colorectal cancer patients, achieving 78% sensitivity post-surgery and 91% during surveillance, with specificities of 80% and 94% respectively.
The Beta-CORRECT study confirmed Oncodetect's prognostic value across stages II, III, and IV colon cancer and rectal cancer. The company plans to launch Oncodetect in Q2 2025 with Medicare coverage. Exact Sciences has established partnerships with NSABP and Flatiron Health to generate additional clinical evidence across multiple solid tumor types, including the CORRECT-I, CORRECT-II, and EXActDNA-003 studies.
Exact Sciences (NASDAQ: EXAS) ha rivelato dati di validazione clinica per il suo test Oncodetect MRD durante l'ASCO GI 2025. Lo studio Alpha-CORRECT ha dimostrato l'efficacia del test nel rilevare la malattia residua molecolare nei pazienti affetti da carcinoma colorettale, raggiungendo una sensibilità del 78% dopo l'intervento chirurgico e del 91% durante il monitoraggio, con specificità dell'80% e del 94% rispettivamente.
Lo studio Beta-CORRECT ha confermato il valore prognostico di Oncodetect nelle fasi II, III e IV del carcinoma del colon e del retto. L'azienda prevede di lanciare Oncodetect nel secondo trimestre del 2025 con copertura Medicare. Exact Sciences ha stretto partnership con NSABP e Flatiron Health per generare ulteriori prove cliniche su diversi tipi di tumori solidi, inclusi gli studi CORRECT-I, CORRECT-II e EXActDNA-003.
Exact Sciences (NASDAQ: EXAS) reveló datos de validación clínica para su prueba Oncodetect MRD en ASCO GI 2025. El estudio Alpha-CORRECT demostró la efectividad de la prueba para detectar enfermedad residual molecular en pacientes con cáncer colorrectal, alcanzando una sensibilidad del 78% después de la cirugía y del 91% durante la vigilancia, con especificidades del 80% y 94% respectivamente.
El estudio Beta-CORRECT confirmó el valor pronóstico de Oncodetect en las etapas II, III y IV del cáncer de colon y recto. La empresa planea lanzar Oncodetect en el segundo trimestre de 2025 con cobertura de Medicare. Exact Sciences ha establecido asociaciones con NSABP y Flatiron Health para generar evidencia clínica adicional en múltiples tipos de tumores sólidos, incluidos los estudios CORRECT-I, CORRECT-II y EXActDNA-003.
엑자트 사이언스 (NASDAQ: EXAS)는 ASCO GI 2025에서 온코디텍 MRD 테스트의 임상 검증 데이터를 공개했습니다. 알파-CORRECT 연구는 이 테스트가 대장암 환자에서 분자 잔여 질병을 감지하는 데 효과적임을 보여주었으며, 수술 후 78%의 민감성과 모니터링 중 91%의 민감성을 달성하고 각각 80%와 94%의 특이성을 보였습니다.
베타-CORRECT 연구는 온코디텍의 예후 가치를 II, III 및 IV기 대장암 및 직장암에서 확인했습니다. 회사는 2025년 2분기에 메디케어 커버리지와 함께 온코디텍을 출시할 계획입니다. 엑자트 사이언스는 다양한 고형 종양 유형에 대한 추가 임상 증거를 생성하기 위해 NSABP 및 Flatiron Health와 파트너십을 구축했습니다. 이에는 CORRECT-I, CORRECT-II 및 EXActDNA-003 연구가 포함됩니다.
Exact Sciences (NASDAQ: EXAS) a révélé des données de validation clinique pour son test Oncodetect MRD lors de l'ASCO GI 2025. L'étude Alpha-CORRECT a démontré l'efficacité du test pour détecter la maladie résiduelle moléculaire chez les patients atteints de cancer colorectal, atteignant une sensibilité de 78 % après la chirurgie et de 91 % pendant la surveillance, avec des spécificités de 80 % et 94 % respectivement.
L'étude Beta-CORRECT a confirmé la valeur pronostique d'Oncodetect aux stades II, III et IV du cancer du côlon et du rectum. L'entreprise prévoit de lancer Oncodetect au deuxième trimestre 2025 avec une couverture Medicare. Exact Sciences a établi des partenariats avec NSABP et Flatiron Health pour générer des preuves cliniques supplémentaires dans plusieurs types de tumeurs solides, y compris les études CORRECT-I, CORRECT-II et EXActDNA-003.
Exact Sciences (NASDAQ: EXAS) hat bei der ASCO GI 2025 klinische Validierungsdaten für seinen Oncodetect MRD-Test veröffentlicht. Die Alpha-CORRECT-Studie zeigte die Wirksamkeit des Tests bei der Erkennung von molekularer Residualerkrankung bei Patienten mit kolorektalem Krebs und erreichte eine Sensitivität von 78 % nach der Operation und 91 % während der Überwachung, mit spezifitäten von 80 % und 94 %.
Die Beta-CORRECT-Studie bestätigte den prognostischen Wert von Oncodetect in den Stadien II, III und IV des Dickdarm- und Rektalkrebses. Das Unternehmen plant, Oncodetect im zweiten Quartal 2025 mit Medicare-Abdeckung auf den Markt zu bringen. Exact Sciences hat Partnerschaften mit NSABP und Flatiron Health geschlossen, um zusätzliche klinische Evidenz bei verschiedenen soliden Tumorarten zu generieren, darunter die Studien CORRECT-I, CORRECT-II und EXActDNA-003.
- Strong clinical validation results with 78% sensitivity post-surgery and 91% during surveillance
- Planned launch in Q2 2025 with Medicare coverage secured
- Successful achievement of primary endpoint in Beta-CORRECT study
- Extension of prognostic value across multiple cancer stages
- Strategic partnerships with NSABP and Flatiron Health for additional clinical evidence generation
- None.
Insights
The newly released clinical validation data for Exact Sciences' Oncodetect MRD test represents a significant advancement in cancer recurrence monitoring. The test's performance metrics are notably strong - achieving
The expansion of the test's capabilities to multiple cancer stages (II, III and IV) and rectal cancer through the Beta-CORRECT study significantly broadens its market potential. This versatility is important as it allows for comprehensive patient monitoring across different disease stages, potentially establishing Oncodetect as a standard tool in cancer care.
From a business perspective, three key elements make this development particularly compelling: 1) The planned Q2 2025 launch with Medicare coverage ensures immediate market access and reimbursement, 2) Exact Sciences' existing relationships with healthcare professionals through their Oncotype DX platform provides a ready-made distribution channel and 3) The strategic partnerships with NSABP and Flatiron Health enable rapid evidence generation across multiple cancer types, potentially accelerating market adoption.
The MRD testing market is experiencing rapid growth, driven by increasing demand for personalized cancer monitoring and treatment optimization. Exact Sciences' established commercial infrastructure and two decades of physician trust position it favorably against competitors in this space. The company's comprehensive approach - combining testing capabilities with advanced technology platforms and broad oncology solutions - could create significant barriers to entry for potential competitors.
The successful clinical validation of Oncodetect positions Exact Sciences to capture a significant share of the rapidly growing MRD testing market, which is projected to reach several billion dollars annually. The planned Q2 2025 launch with Medicare coverage is particularly noteworthy, as it removes a important barrier to market adoption and should accelerate revenue generation.
The company's strategic approach leverages its established Oncotype DX commercial infrastructure, which could significantly reduce customer acquisition costs and accelerate market penetration. The comprehensive partnership strategy with NSABP and Flatiron Health not only supports clinical evidence generation but also creates potential for market expansion into multiple cancer types, representing additional revenue streams.
Near-term catalysts include the upcoming publication of complete Alpha-CORRECT study findings in a peer-reviewed journal (January 25) and future data presentations from the Beta-CORRECT study. These events could drive investor interest and potentially impact stock valuation. The company's robust commercial infrastructure and established relationships with healthcare providers create significant competitive advantages in the MRD testing space.
From a financial perspective, the successful launch of Oncodetect could meaningfully impact Exact Sciences' revenue growth trajectory. The test's broad application across multiple cancer stages and types, combined with Medicare coverage, suggests strong potential for widespread adoption and sustained revenue growth.
Results from prospective molecular residual disease (MRD) study show a positive Oncodetect test result is strongly associated with recurrence in stage III colon cancer patients
Oncodetect test achieved the primary endpoint in a second clinical validation study, extending its prognostic value into stages II and IV colon cancer and rectal cancer
Exact Sciences plans to launch the Oncodetect test in Q2 2025 with Medicare coverage
Key collaborations support clinical evidence generation across multiple solid tumor types
“We’re thrilled to bring our MRD solution to the rapidly growing molecular residual disease market, helping more patients get access to critical, high-quality testing,” said Brian Baranick, general manager of Precision Oncology at Exact Sciences. “These data demonstrate the strong performance of Oncodetect. Building on the foundation of Oncotype DX® and two decades of trust from physicians and patients, Exact Sciences is well positioned to lead the way with its robust commercial and operational infrastructure, to ensure patients across the
In addition to the data shared at ASCO GI, Oncodetect achieved its primary endpoint in the Beta-CORRECT study. Results confirm a significant association between MRD positivity and recurrence in patients with stage III colon cancer. The data extend Oncodetect’s prognostic value to patients with stage II and IV colon cancer and rectal cancer. Findings from the independent Beta-CORRECT clinical validation study, which was a subset analysis from the GALAXY study, also demonstrated promising performance of Oncodetect as an MRD test. Results will be presented at an upcoming scientific conference.
“There is a critical need to better understand and monitor for residual cancer following surgery,” said Takayuki Yoshino, MD, deputy director at the National Cancer Center Hospital East in
The company plans to provide the Oncodetect test to patients across
Strategic Partnerships Support Multi-Cancer Evidence Generation
Exact Sciences has partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types.
- Exact Sciences is conducting multiple studies to strengthen evidence in colorectal cancer. The international-based CORRECT-I study and the pivotal, US-based CORRECT-II study with the NSABP will assess the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer. These studies will further validate ctDNA’s role in colorectal cancer recurrence monitoring.
- An additional study with the NSABP, EXActDNA-003, is one of the largest prospective MRD studies across all subtypes of early-stage breast cancer. Additional research in breast cancer was previously announced with the West German Study Group.
- The company has also partnered with Flatiron Health on a multi-year, prospective real-world study that will be integrated into routine clinical care, with the goal of accelerated enrollment across a broad range of solid tumors.
“The NSABP is committed to advancing colorectal and breast cancer care through innovative clinical studies that redefine diagnostics and treatments,” said Dr. Norman Wolmark, MD, chairman of the NSABP Foundation and contact principal investigator and co-chair at NRG Oncology. “Both the CORRECT-II and EXActDNA-003 studies are designed to utilize ctDNA in addressing critical gaps left by previous MRD trials. Through our collaboration with Exact Sciences, we aim to integrate ctDNA analysis to deliver a more precise and comprehensive approach to recurrence detection.”
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’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra® test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.
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.
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 our expectations for the commercialization of the Oncodetect test and the performance of the Oncodetect test 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121399220/en/
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 sensitivity and specificity rates of EXAS's Oncodetect MRD test in colorectal cancer?
When will Exact Sciences (EXAS) launch the Oncodetect MRD test?
What cancer stages does EXAS's Oncodetect test cover according to the Beta-CORRECT study?
Which strategic partnerships has EXAS formed for Oncodetect clinical evidence generation?
What studies is EXAS conducting to validate Oncodetect in colorectal cancer?
