FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening
Exact Sciences Corp. (NASDAQ: EXAS) announced FDA approval for its Cologuard Plus™ test, a next-generation multitarget stool DNA test for colorectal cancer (CRC) screening. The test is approved for adults 45 and older at average risk for CRC. Key highlights:
1. 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity
2. Significantly outperformed fecal immunochemical test (FIT) in various sensitivity measures
3. Expected launch in 2025 with Medicare coverage and guideline inclusion
4. Builds on success of original Cologuard test, used over 17 million times
The company aims to improve CRC screening rates and outcomes by detecting cancer early and finding advanced precancers.
Exact Sciences Corp. (NASDAQ: EXAS) ha annunciato l'approvazione della FDA per il suo test Cologuard Plus™, un test di ultima generazione per il DNA fecale multitarget per la screening del cancro colorettale (CRC). Il test è approvato per adulti di 45 anni e oltre con rischio medio di CRC. Punti salienti:
1. 95% di sensibilità complessiva per il cancro e 43% di sensibilità per lesioni precancerose avanzate con una specificità del 94%
2. Ha superato significativamente il test immunochimico fecale (FIT) in vari parametri di sensibilità
3. Lancio previsto nel 2025 con copertura Medicare e inclusione nelle linee guida
4. Si basa sul successo del test Cologuard originale, utilizzato oltre 17 milioni di volte
La società mira a migliorare i tassi di screening e i risultati per il CRC rilevando precocemente i tumori e trovando precursori avanzati del cancro.
Exact Sciences Corp. (NASDAQ: EXAS) anunció la aprobación de la FDA para su test Cologuard Plus™, una prueba de ADN en heces multitarget de próxima generación para el cribado del cáncer colorrectal (CRC). La prueba está aprobada para adultos de 45 años o más con riesgo promedio de CRC. Aspectos destacados:
1. 95% de sensibilidad general para el cáncer y 43% de sensibilidad para lesiones precoces avanzadas con una especificidad del 94%
2. Superó significativamente a la prueba inmunoquímica fecal (FIT) en varias medidas de sensibilidad
3. Lanzamiento esperado en 2025 con cobertura de Medicare e inclusión en las directrices
4. Se basa en el éxito de la prueba Cologuard original, utilizada más de 17 millones de veces
La compañía tiene como objetivo mejorar las tasas de cribado y los resultados del CRC mediante la detección temprana del cáncer y la identificación de precánceres avanzados.
Exact Sciences Corp. (NASDAQ: EXAS)는 Cologuard Plus™ 검사에 대한 FDA 승인을 발표했습니다. 이는 대장암(CRC) 선별을 위한 차세대 다중 표적 대변 DNA 검사입니다. 이 검사는 CRC에 대한 평균 위험이 있는 45세 이상의 성인에게 승인을 받았습니다. 주요 내용:
1. 전체 암에 대한 95%의 민감도와 진행된 전암 병변에 대한 43%의 민감도를 가진 94%의 특이성
2. 다양한 민감도 측정에서 대변 면역화학 검사(FIT)를 크게 초과함
3. Medicare 보장 및 가이드라인 포함과 함께 2025년에 출시할 예정
4. 1,700만 번 이상 사용된 기존 Cologuard 검사의 성공을 기반으로 함
회사는 암을 조기에 발견하고 전암을 찾아 CRC 선별률과 결과를 개선하는 것을 목표로 하고 있습니다.
Exact Sciences Corp. (NASDAQ: EXAS) a annoncé l'approbation de la FDA pour son test Cologuard Plus™, un test d'ADN fécal multitarget de nouvelle génération pour le dépistage du cancer colorectal (CRC). Le test est approuvé pour les adultes de 45 ans et plus à risque moyen de CRC. Points forts :
1. 95% de sensibilité globale au cancer et 43% de sensibilité pour les lésions précancéreuses avancées avec une spécificité de 94%
2. A surpassé de manière significative le test immunochimique fécal (FIT) dans diverses mesures de sensibilité
3. Lancement prévu en 2025 avec couverture Medicare et inclusion dans les lignes directrices
4. S'appuie sur le succès du test Cologuard original, utilisé plus de 17 millions de fois
L'entreprise vise à améliorer les taux de dépistage et les résultats du CRC en détectant le cancer précocement et en identifiant des précancres avancés.
Exact Sciences Corp. (NASDAQ: EXAS) gab die FDA-Zulassung für seinen Cologuard Plus™-Test bekannt, einen multizieligen Stuhl-DNA-Test der nächsten Generation zur Screening von Kolorektalkrebs (CRC). Der Test ist für Erwachsene ab 45 Jahren mit durchschnittlichem Risiko für CRC zugelassen. Hauptmerkmale:
1. 95% Gesamtsensitivität für Krebs und 43% Sensitivität für fortgeschrittene vor Krebs stehende Läsionen bei 94% Spezifität
2. Übertraf die fäkale immunochemische Prüfung (FIT) in verschiedenen Sensitivitätsmessungen erheblich
3. Erwartete Einführung im Jahr 2025 mit Medicare-Abdeckung und Einbeziehung in die Richtlinien
4. Baut auf dem Erfolg des ursprünglichen Cologuard-Tests auf, der über 17 Millionen Mal eingesetzt wurde
Das Unternehmen hat sich zum Ziel gesetzt, die Screening-Quoten und Ergebnisse für CRC zu verbessern, indem Krebs frühzeitig erkannt und fortgeschrittene Vorstufen gefunden werden.
- FDA approval of Cologuard Plus test for colorectal cancer screening
- High sensitivity (95% for cancer, 43% for advanced precancerous lesions) at 94% specificity
- Outperformed fecal immunochemical test (FIT) in key sensitivity measures
- Expected Medicare coverage and inclusion in USPSTF guidelines upon 2025 launch
- Potential to reduce unnecessary follow-up colonoscopies by lowering false-positive rates
- Launch of Cologuard Plus test not expected until 2025, delaying potential revenue impact
Insights
The FDA approval of Exact Sciences' Cologuard Plus test marks a significant advancement in non-invasive colorectal cancer (CRC) screening. With 95% sensitivity for CRC and 43% for advanced precancerous lesions at 94% specificity, it outperforms the current standard. This improvement could lead to earlier detection and prevention of CRC, potentially saving more lives.
Key points:
- Higher sensitivity and specificity compared to the original Cologuard test
- Reduction in false positives by
30% - Outperformed FIT in multiple sensitivity measures
- Anticipated Medicare coverage and inclusion in USPSTF guidelines
The expected 2025 launch with Medicare coverage and guideline inclusion could drive rapid adoption, potentially boosting Exact Sciences' market share in the
Exact Sciences' FDA approval for Cologuard Plus is a game-changer for the company's financial outlook. With a market cap of
- Potential for increased test volume and revenue growth from 2025 onwards
- Likely expansion of the addressable market due to improved test performance
- Enhanced competitive position against other screening methods
- Possible increase in reimbursement rates due to superior performance
The company's strong commercial organization and ExactNexus platform provide a solid foundation for rapid market penetration. With over 17 million Cologuard tests already performed, Exact Sciences has an established user base to facilitate adoption of the improved test. Investors should watch for potential upward revisions in long-term revenue forecasts and margin expansion as Cologuard Plus rolls out.
Cologuard Plus™ test raises the performance bar with sensitivities of
Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test
Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025
FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer,” said Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study. “The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”
“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said Kevin Conroy, Chairman and CEO of Exact Sciences. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”
CRC is often considered the most preventable, yet least prevented form of cancer.3 It remains the second deadliest cancer in
*The Cologuard Plus test demonstrates
**Refers to the commercially available Polymedco OC-Auto® Micro 80iFOB Test
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. The trial was designed to evaluate the performance of the Cologuard Plus test (multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based colorectal cancer screening test. Using colonoscopy as a reference method, the robust study design directly compared the Cologuard Plus test and an independent fecal immunochemical test (FIT*). The BLUE-C study cohort is diverse and reflective of the
About the Cologuard Plus test
Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences' lab and increase the valid result rate. Exact Sciences is preparing for the commercialization of the Cologuard Plus test.
About the Cologuard test
The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the
The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal DeeP-C study. The Cologuard test is easy to use, can be completed at home, and does not require any time off or special preparation.
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 or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. The Cologuard and Cologuard Plus tests are not available outside of the
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. 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 Cologuard Plus, the performance of Cologuard Plus in a commercial setting, and Cologuard Plus’ receipt of Medicare coverage and inclusion in guidelines. 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
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Cologuard Plus Instructions for Use. Exact Sciences Corporation.
Madison, WI. - Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. New Engl J Med. 2024;390(11):984-993.
- Itzkowitz SH. Incremental advances in excremental cancer detection tests. JNCI. 2009;101(18)1225-1227.
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ACS. Cancer facts & figures 2024.
Atlanta : American Cancer Society; 2024. - National Institutes of Health. The Cancer Trends Progress Report. https://progressreport.cancer.gov/detection/colorectal_cancer. Accessed July 29, 2024.
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Ebner DW, Finney Rutten LJ, Miller-
Wilson LA , et al. Trends in Colorectal Cancer Screening from the National Health Interview Survey: Analysis of the Impact of Different Modalities on Overall Screening Rates. Cancer Prev Res (Phila). 2024;17(6):275-280.
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Media (
Lindsey Dickinson
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lidickinson@exactsciences.com
Investor:
Erik Holznecht
+1 608-800-6605
investorrelations@exactsciences.com
Source: Exact Sciences Corp.
FAQ
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