Exact Sciences Presents Data Demonstrating Advancement in Blood-based Colorectal Cancer Screening at ESMO 2024
Exact Sciences Corp. (NASDAQ: EXAS) presented performance data for its blood-based colorectal cancer (CRC) screening test at the ESMO Congress. The test showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at 90.1% specificity. The study included over 3,000 blood samples, with most from the BLUE-C study.
The company aims to close the screening gap through innovation, combining a novel panel of markers. BLUE-C results are now expected in the first half of 2025, which will support an FDA submission. If approved, this test could provide another option for 60 million unscreened people in the US.
Exact Sciences also presented data on its multi-cancer early detection (MCED) blood test, showing 54.8% sensitivity at 98.5% specificity for cancers without standard screening options, and 63.7% for six aggressive cancers.
Exact Sciences Corp. (NASDAQ: EXAS) ha presentato dati sulle prestazioni del suo test di screening per il cancro colorettale (CRC) basato sul sangue al Congresso ESMO. Il test ha mostrato sensibilità dell'88,3% per il CRC e del 31,2% per le lesioni precancerose avanzate con una specificità del 90,1%. Lo studio ha incluso oltre 3.000 campioni di sangue, la maggior parte dei quali provenienti dallo studio BLUE-C.
L'azienda mira a colmare il divario nello screening attraverso l'innovazione, combinando un nuovo pannello di marcatori. I risultati di BLUE-C sono ora attesi nella prima metà del 2025, il che supporterà una richiesta all'FDA. Se approvato, questo test potrebbe offrire un'opzione aggiuntiva per 60 milioni di persone non sottoposte a screening negli Stati Uniti.
Exact Sciences ha anche presentato dati sul suo test di rilevamento precoce multi-cancro (MCED) basato sul sangue, mostrando una sensibilità del 54,8% con una specificità del 98,5% per i tumori senza opzioni di screening standard, e del 63,7% per sei tumori aggressivi.
Exact Sciences Corp. (NASDAQ: EXAS) presentó datos de rendimiento para su prueba de detección de cáncer colorrectal (CRC) basada en sangre en el Congreso ESMO. La prueba mostró sensibilidades del 88,3% para CRC y del 31,2% para lesiones precoces avanzadas con una especificidad del 90,1%. El estudio incluyó más de 3,000 muestras de sangre, la mayoría del estudio BLUE-C.
La empresa tiene como objetivo cerrar la brecha en la detección a través de la innovación, combinando un nuevo panel de marcadores. Se esperan los resultados de BLUE-C en la primera mitad de 2025, lo que apoyará una presentación ante la FDA. Si se aprueba, esta prueba podría proporcionar otra opción para 60 millones de personas no examinadas en los EE. UU.
Exact Sciences también presentó datos sobre su prueba de detección temprana de múltiples cánceres (MCED) basada en sangre, mostrando una sensibilidad del 54,8% con una especificidad del 98,5% para cánceres sin opciones de detección estándar, y del 63,7% para seis cánceres agresivos.
엑자트 사이언스 Corp. (NASDAQ: EXAS)가 ESMO 콘그레스에서 혈액 기반 대장암 (CRC) 검사의 성능 데이터를 발표했습니다. 이 테스트는 90.1%의 특이도로 CRC에 대한 민감도 88.3%, 진행된 전암 병변에 대한 민감도 31.2%를 보였습니다. 연구에는 3,000개 이상의 혈액 샘플이 포함되었으며, 대부분은 BLUE-C 연구에서 출처를 얻었습니다.
회사는 혁신을 통해 검진 격차를 해소할 계획이며, 새로운 마커 패널을 결합하고 있습니다. BLUE-C 결과는 2025년 상반기 중 발표될 예정입니다, 이는 FDA 제출을 지원할 것입니다. 만약 승인이 된다면 이 검사는 미국에서 검사를 받지 않은 6천만 명을 위한 또 다른 옵션이 될 수 있습니다.
엑자트 사이언스는 또한 다중 암 조기 발견 (MCED) 혈액 검사에 대한 데이터를 발표했으며, 표준 검진 옵션이 없는 암에 대해 98.5%의 특이도로 54.8%의 민감도를, 6개의 공격적인 암에 대해서는 63.7%의 민감도를 보였습니다.
Exact Sciences Corp. (NASDAQ: EXAS) a présenté des données de performance pour son test de dépistage du cancer colorectal (CRC) basé sur du sang lors du Congrès ESMO. Le test a montré des sensibilités de 88,3 % pour le CRC et de 31,2 % pour les lésions précoces avancées avec une spécificité de 90,1 %. L'étude a inclus plus de 3 000 échantillons de sang, dont la plupart provenaient de l'étude BLUE-C.
L'entreprise vise à combler l'écart de dépistage grâce à l'innovation, en combinant un nouveau panel de marqueurs. Les résultats de BLUE-C sont désormais attendus au cours du premier semestre 2025, ce qui soutiendra une soumission à la FDA. Si cela est approuvé, ce test pourrait fournir une autre option pour 60 millions de personnes non dépistées aux États-Unis.
Exact Sciences a également présenté des données sur son test sanguin de détection précoce de plusieurs cancers (MCED), montrant une sensibilité de 54,8 % avec une spécificité de 98,5 % pour les cancers sans options de dépistage standard, et 63,7 % pour six cancers agressifs.
Exact Sciences Corp. (NASDAQ: EXAS) hat beim ESMO-Kongress Leistungsdaten für seinen blutbasierten Test zur Krebsfrüherkennung (CRC) präsentiert. Der Test zeigte eine Sensitivität von 88,3% für CRC und 31,2% für fortgeschrittene präkanzeröse Läsionen bei einer Spezifität von 90,1%. Die Studie umfasste über 3.000 Blutproben, von denen die meisten aus der BLUE-C-Studie stammten.
Das Unternehmen hat sich zum Ziel gesetzt, die Screening-Lücke durch Innovation zu schließen, indem es ein neues Panel von Markern kombiniert. Die Ergebnisse der BLUE-C-Studie werden nun in der ersten Hälfte von 2025 erwartet, was die Einreichung bei der FDA unterstützen wird. Bei genehmigung könnte dieser Test eine weitere Option für 60 Millionen nicht gescreente Menschen in den USA bieten.
Exact Sciences präsentierte auch Daten zu seinem Bluttest zur frühzeitigen Erkennung von Mehrfachkrebs (MCED), der eine Sensitivität von 54,8% bei einer Spezifität von 98,5% für Krebserkrankungen ohne Standard-Screening-Optionen und 63,7% für sechs aggressive Krebserkrankungen zeigte.
- High sensitivity (88.3%) for colorectal cancer detection
- Potential to provide a new non-invasive screening option for 60 million unscreened people in the US
- MCED blood test shows promising results for detecting multiple cancer types, including aggressive ones
- Test could be integrated with Exact Sciences' existing commercial infrastructure and ExactNexus™ technology platform
- BLUE-C study results delayed to first half of 2025
- Expected performance degradation in pivotal BLUE-C study for advanced precancerous lesion and overall CRC sensitivity
- Additional analytical studies required to support FDA submission
Insights
This data presentation marks a significant advancement in blood-based colorectal cancer (CRC) screening. The reported 88.3% sensitivity for CRC and 31.2% for advanced precancerous lesions at 90.1% specificity is impressive. These figures suggest potential for early detection of both cancerous and precancerous conditions, which is important for improving patient outcomes.
The study's design, simulating the U.S. screening population with over 3,000 blood samples, adds credibility to the results. The inclusion of 90+ advanced precancerous lesions is particularly noteworthy, as detecting these is a key challenge in CRC screening. However, it's important to note that performance degradation is expected in the pivotal BLUE-C study, which will be important for FDA submission.
If approved, this blood-based test could significantly impact CRC screening rates, potentially reaching 60 million unscreened people in the U.S. The integration with Exact Sciences' ExactNexus™ platform could streamline adoption in healthcare systems.
The potential of this blood-based test to detect advanced precancerous lesions at levels comparable to FIT tests is groundbreaking. Current non-invasive options like FIT have limitations in detecting precancerous lesions, which are important for prevention. A blood test with 31.2% sensitivity for advanced precancerous lesions could significantly enhance early intervention strategies.
The 88.3% sensitivity for CRC is promising, approaching the effectiveness of colonoscopy, the gold standard. This could lead to earlier diagnoses and improved survival rates. However, we must await the BLUE-C study results for a more definitive assessment.
The multi-cancer early detection (MCED) data is also intriguing, showing 54.8% sensitivity at 98.5% specificity for cancers without standard screening. This could revolutionize our approach to cancers that are typically diagnosed at later stages due to lack of screening options.
Exact Sciences' (NASDAQ: EXAS) advancement in blood-based CRC screening could significantly impact its market position. If approved, this test could tap into a vast market of 60 million unscreened individuals in the U.S., potentially driving substantial revenue growth.
The company's existing commercial infrastructure and ExactNexus™ platform provide a strong foundation for rapid market penetration. Integration with 350+ health systems could accelerate adoption and revenue realization.
The multi-cancer early detection (MCED) test results, showing promise in detecting aggressive cancers, could open additional market opportunities. However, investors should note that full BLUE-C study results are expected in H1 2025, with FDA approval timeline uncertain. This extended timeline may affect short-term stock performance, but the long-term potential remains strong if the final results meet expectations.
Data presented show sensitivities of
Scientific insights reflect Exact Sciences’ commitment to closing the screening gap through innovation
Results shared alongside evidence supporting multi-cancer early detection approach
“The Exact Sciences team is constantly innovating to help close the screening gap,” said Kevin Conroy, chairman and CEO, Exact Sciences. “The insights that led to this innovation reflect our understanding of the biology of cancer and the power of our scientific capabilities. We took a unique scientific approach to developing this test by combining a novel panel of markers. This led to data that improve upon what we previously thought was possible with a blood-based colorectal cancer screening test.”
To optimize the final test algorithm, Exact Sciences designed a study to simulate the screening population in
Results of this study show the potential of a novel, highly discriminate blood-based panel of methylated DNA markers and an impactful, new marker class to detect advanced precancerous lesions and cancers at an attractive cost profile. The company will implement the innovative marker class on a new testing platform and complete additional analytical studies to support an FDA submission.
“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences. “Results from this large, well-designed study show progress toward that goal and move us one step closer toward providing average-risk patients with another non-invasive screening option.”
BLUE-C results for Exact Sciences’ blood-based CRC screening test are now expected in the first half of 2025. Exact Sciences plans to use these results to support an FDA submission and approval and to make the blood-based CRC screening test available broadly. If approved, the blood-based CRC screening test could provide another testing option for 60 million unscreened people1 in
The company also presented data from its multi-cancer early detection (MCED) blood test, assessing organ-specific performance of methylation and protein biomarkers in a prospectively collected cohort of samples from its ASCEND 2 study. The analysis indicated an overall sensitivity of
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 the BLUE-C Study
BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older.1 The trial was designed to evaluate the performance of the Cologuard PlusTM test (next generation multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based CRC screening test. BLUE-C is one of the largest, noninvasive CRC screening trials ever conducted, and the study population reflects the racial and ethnic makeup of
Forward-Looking Statements
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. There can be no assurance that we will successfully develop, launch, or market a blood-based CRC screening test, an MCED test, or any other new or improved product or service. Therefore, you should not place undue reliance on forward-looking statements. 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
1. Ebner DW, Kisiel JB, Fendrick AM, et al. Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US. JAMA Netw Open. 2024;7(3):e245537.
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Media Contact:
Morry Smulevitz, msmulevitz@exactsciences.com, 608-345-8010
Investor Contact:
Erik Holznecht, investorrelations@exactsciences.com, 608-800-6605
Source: Exact Sciences Corp.
FAQ
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