Exact Sciences Launches the Cologuard Plus™ Test, Transforming Colorectal Cancer Screening
Exact Sciences (NASDAQ: EXAS) has launched Cologuard Plus™, a groundbreaking colorectal cancer screening test demonstrating 95% sensitivity for cancer detection at 94% specificity - making it the most accurate noninvasive screening option to date.
The FDA-approved test shows significant improvements over its predecessor, including up to 40% reduction in unnecessary follow-up colonoscopies compared to the original Cologuard® test. Key features include 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia. The test maintains a 99.98% negative predictive value.
Building on Cologuard's success of over 19 million screenings in the past decade, the new test is backed by the 20,000+ person BLUE-C study published in the New England Journal of Medicine. The test is covered by Medicare, included in USPSTF guidelines, and maintains strong patient adherence with 71% completion rate within 28 days.
Exact Sciences (NASDAQ: EXAS) ha lanciato Cologuard Plus™, un innovativo test di screening per il cancro colorettale che dimostra una sensibilità del 95% per la rilevazione del cancro con una specificità del 94% - rendendolo l'opzione di screening non invasiva più accurata fino ad oggi.
Il test approvato dalla FDA mostra miglioramenti significativi rispetto al suo predecessore, inclusa una riduzione fino al 40% delle colonscopie di follow-up non necessarie rispetto al test originale Cologuard®. Le caratteristiche principali includono una sensibilità del 43% per lesioni precancerose avanzate e del 74% per displasia di alto grado. Il test mantiene un valore predittivo negativo del 99,98%.
Basandosi sul successo di Cologuard, che ha visto oltre 19 milioni di screening nell'ultimo decennio, il nuovo test è supportato dallo studio BLUE-C, che coinvolge oltre 20.000 persone e pubblicato nel New England Journal of Medicine. Il test è coperto da Medicare, è incluso nelle linee guida USPSTF e mantiene una forte adesione da parte dei pazienti con un tasso di completamento del 71% entro 28 giorni.
Exact Sciences (NASDAQ: EXAS) ha lanzado Cologuard Plus™, una prueba innovadora de detección de cáncer colorrectal que demuestra una sensibilidad del 95% para la detección de cáncer con una especificidad del 94% - convirtiéndola en la opción de detección no invasiva más precisa hasta la fecha.
La prueba aprobada por la FDA muestra mejoras significativas en comparación con su predecesora, incluyendo una reducción de hasta el 40% en colonoscopias de seguimiento innecesarias en comparación con la prueba original Cologuard®. Las características clave incluyen una sensibilidad del 43% para lesiones precoces avanzadas y del 74% para displasia de alto grado. La prueba mantiene un valor predictivo negativo del 99.98%.
Basándose en el éxito de Cologuard, que ha realizado más de 19 millones de pruebas en la última década, la nueva prueba cuenta con el respaldo del estudio BLUE-C, que involucra a más de 20,000 personas y se publicó en el New England Journal of Medicine. La prueba está cubierta por Medicare, incluida en las directrices de USPSTF y mantiene una fuerte adherencia de los pacientes con una tasa de finalización del 71% dentro de los 28 días.
엑잭트 사이언스(Exact Sciences) (NASDAQ: EXAS)는 콜로가드 플러스™(Cologuard Plus™)를 출시했습니다. 이 혁신적인 대장암 검진 테스트는 암 탐지에서 95%의 민감도와 94%의 특이도를 보여주며, 현재까지 가장 정확한 비침습적 검진 옵션입니다.
FDA 승인을 받은 이 테스트는 이전 모델에 비해 상당한 개선을 보여주며, 원래의 콜로가드(Cologuard®) 테스트에 비해 불필요한 후속 대장내시경 검사가 최대 40% 감소했습니다. 주요 특징으로는 고급 전암 병변에 대한 43%의 민감도와 고등급 이형성에 대한 74%의 민감도가 포함됩니다. 이 테스트는 99.98%의 음성 예측 값을 유지합니다.
지난 10년간 1900만 건 이상의 검진을 기록한 콜로가드의 성공을 바탕으로, 새로운 테스트는 20,000명 이상의 참여자를 대상으로 한 BLUE-C 연구의 지원을 받고 있으며, 이 연구는 뉴잉글랜드 의학 저널(New England Journal of Medicine)에 발표되었습니다. 이 테스트는 메디케어에서 보장되며, USPSTF 가이드라인에 포함되어 있으며, 28일 이내에 71%의 완료율로 환자의 높은 참여도를 유지합니다.
Exact Sciences (NASDAQ: EXAS) a lancé Cologuard Plus™, un test de dépistage du cancer colorectal révolutionnaire qui démontre une sensibilité de 95 % pour la détection du cancer avec une spécificité de 94 % - en faisant l'option de dépistage non invasive la plus précise à ce jour.
Le test approuvé par la FDA montre des améliorations significatives par rapport à son prédécesseur, y compris une réduction allant jusqu'à 40 % des coloscopies de suivi inutiles par rapport au test Cologuard® original. Les caractéristiques clés incluent une sensibilité de 43 % pour les lésions précancéreuses avancées et une sensibilité de 74 % pour la dysplasie de haut grade. Le test maintient une valeur prédictive négative de 99,98 %.
S'appuyant sur le succès de Cologuard, qui a réalisé plus de 19 millions de dépistages au cours de la dernière décennie, le nouveau test est soutenu par l'étude BLUE-C, qui implique plus de 20 000 personnes et publiée dans le New England Journal of Medicine. Le test est couvert par Medicare, inclus dans les directives USPSTF et maintient une forte adhésion des patients avec un taux d'achèvement de 71 % dans les 28 jours.
Exact Sciences (NASDAQ: EXAS) hat Cologuard Plus™ eingeführt, einen bahnbrechenden Test zur Früherkennung von Darmkrebs, der eine Sensitivität von 95% für die Krebsdetektion bei einer Spezifität von 94% aufweist - was ihn zur genauesten nicht-invasiven Screening-Option bis heute macht.
Der von der FDA zugelassene Test zeigt signifikante Verbesserungen im Vergleich zu seinem Vorgänger, einschließlich einer Reduktion von bis zu 40% unnötiger Nachuntersuchungen durch Koloskopien im Vergleich zum ursprünglichen Cologuard®-Test. Zu den wichtigsten Merkmalen gehören eine Sensitivität von 43% für fortgeschrittene präkanzeröse Läsionen und 74% Sensitivität für hochgradige Dysplasie. Der Test behält einen negativen prädiktiven Wert von 99,98% bei.
Auf dem Erfolg von Cologuard, das in den letzten zehn Jahren über 19 Millionen Screenings durchgeführt hat, aufbauend, wird der neue Test durch die über 20.000 Teilnehmer umfassende BLUE-C-Studie unterstützt, die im New England Journal of Medicine veröffentlicht wurde. Der Test wird von Medicare übernommen, ist in den USPSTF-Richtlinien enthalten und weist eine hohe Patientenadhärenz mit einer Abschlussquote von 71% innerhalb von 28 Tagen auf.
- Launched most accurate noninvasive colorectal cancer screening test with 95% sensitivity
- 40% reduction in unnecessary follow-up colonoscopies compared to original test
- Strong patient adherence rate of 71% completion within 28 days
- Broad insurance coverage with 96% of eligible patients having no out-of-pocket costs
- Backed by extensive 20,000+ person BLUE-C study published in NEJM
- None.
Insights
Exact Sciences' new Cologuard Plus test represents a significant advancement in colorectal cancer (CRC) screening technology with substantial commercial implications. The 95% sensitivity for CRC detection at 94% specificity positions this as the most accurate noninvasive screening option available, dramatically outperforming the standard FIT test (95% vs 71% sensitivity).
The 40% reduction in false positives compared to the original Cologuard addresses a critical limitation in the previous generation product, potentially expanding physician adoption and reducing unnecessary follow-up procedures. This improvement directly addresses healthcare economic concerns by reducing costly colonoscopies while maintaining detection rates.
Market penetration potential is substantial given existing coverage advantages: Medicare reimbursement is secured, inclusion in USPSTF guidelines is established, and 96% of eligible patients face no out-of-pocket costs. With colorectal cancer being highly treatable when detected early (90% survival rate), and approximately 48 million Americans still unscreened, the addressable market remains significantly underpenetrated.
The improved test builds upon Exact Sciences' established infrastructure that has already enabled over 19 million screenings. The company's integrated technology platform (ExactNexus) for ordering, results delivery, and patient navigation provides competitive barriers while driving the impressive 71% test completion rate within 28 days – substantially outperforming FIT (42%) and colonoscopy referrals (38%).
This launch represents both a defensive move to protect Exact Sciences' dominant position in non-invasive CRC screening and an offensive strategy to expand market penetration through improved accuracy and reduced false positives.
The Cologuard Plus launch introduces compelling economic benefits throughout the healthcare ecosystem. The 40% reduction in false positives compared to the original Cologuard directly translates to fewer unnecessary colonoscopies, generating significant cost savings for payers and reducing burden on gastroenterology practices already facing capacity constraints.
The test's high completion rate (71% within 28 days) compared to alternatives represents a critical efficiency metric. Each percentage point improvement in screening compliance potentially translates to earlier cancer detection and treatment cost reduction. The 83% adherence to repeat screening further compounds this economic advantage by maintaining protective surveillance.
For health systems and providers, Cologuard Plus satisfies three years of colorectal cancer screening quality measure credit, directly impacting value-based reimbursement programs and quality ratings. The established Medicare coverage and inclusion in USPSTF guidelines eliminates reimbursement uncertainty that typically hampers adoption of new diagnostic technologies.
Exact Sciences' integrated ExactNexus platform reduces administrative burden through streamlined ordering and result delivery processes. The at-home collection maintains the original Cologuard's accessibility advantages while delivering improved accuracy, creating a rare win-win in healthcare economics where patient convenience, clinical performance, and cost-effectiveness all improve simultaneously.
With colorectal cancer treatment costs substantially higher for late-stage diagnosis, the improved early detection capabilities of Cologuard Plus (especially the 74% sensitivity for high-grade dysplasia) represent significant downstream cost-avoidance potential for the healthcare system beyond the immediate procedural savings from reduced false positives.
The Cologuard Plus test demonstrated
Cologuard Plus Box
Building on the trust and success of Cologuard—used for more than 19 million screenings over the past decade—Cologuard Plus delivers even greater performance while maintaining the convenience of at-home collection. Backed by pivotal data from the 20,000+ person BLUE-C study published in the New England Journal of Medicine, the Cologuard Plus test sets a new standard for noninvasive CRC screening:
-
Unmatched Noninvasive CRC Accuracy*:
95% sensitivity for CRC detection, versus71% sensitivity with fecal immunochemical test (FIT).1 -
Fewer False Positives:
40% reduction compared to the original Cologuard test.2 -
High Precancerous Lesion Detection:
43% sensitivity for advanced precancerous lesions and74% sensitivity for high-grade dysplasia—the type of precancerous growths most likely to become cancer.1 -
Greater Confidence in Negative Results: A negative Cologuard Plus result means a
99.98% chance the patient does not have colorectal cancer—offering peace of mind to both patients and clinicians.1 -
Access & Coverage: Covered by Medicare and included in the
U.S. Preventive Services Taskforce (USPSTF) guidelines as a recommended stool-based screening option. - Recognized for Quality Care: Satisfies three years of colorectal cancer screening quality measure credit, helping health care professionals meet screening goals while improving patient outcomes.
“Cologuard Plus builds on the proven performance of Cologuard,” said Jake Orville, Executive Vice President and General Manager, Screening. “Cologuard transformed colorectal cancer screening—driving an estimated
Driving Better Outcomes Through Early Detection and Adherence
Colorectal cancer is highly treatable when caught early—survivable in about
“Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete,” said Dr. Paul
Effective screening depends on patient adherence, and Cologuard Plus is designed to remove barriers to testing. A large national sample of Cologuard orders shows that
Follow-up adherence is also strong—
Like the original Cologuard test, the Cologuard Plus test is shipped directly to a patient’s home and integrates with the ExactNexus™ technology platform. This platform simplifies ordering, result delivery, and patient navigation—a feature proven to improve test completion rates.10 As Exact Sciences works to expand patient access to the Cologuard Plus test, the original Cologuard test will remain available. Nationwide, more than
* Based on relative comparison to published reports; not direct evidence from head-to-head comparisons with all other screening tests.
†
‡ Based on 5-year survival.
§ Exact Sciences estimate based on historical patient billing as of November 2024. Exceptions for coverage may apply; only patients’ insurers can confirm how the Cologuard test would be covered.
References
-
Cologuard Plus Clinician Brochure.
Madison, WI ; Exact Sciences Corporation. -
Data on file as of March 2025, Exact Sciences,
Madison, WI. -
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. - 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.
- Ladabaum U, Dominitz J, et al. Can molecular cancer signals circulating in blood help us prevent cancer-related deaths? The Lancet. 2025
-
Le, Q, Greene M, Ozbay AB, Dore M, Fendrick AM,
Limburg , P. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening among four largest payers in the country. Abstract presented at: American College of Gastroenterology (ACG) 2024; October 25-30, 2024;Philadelphia, PA. - Singal AG, Gupta S, Skinner CS, et al. Effect of colonoscopy outreach vs fecal immunochemical test outreach on colorectal cancer screening completion: a randomized clinical trial. JAMA. 2017;318(9):806-815.
- Austin G, Kowalkowski H, Gui Y, et al. Patterns of initial colorectal cancer screenings after turning 50 years old and follow-up rates of colonoscopy after a positive stool-based testing among the average-risk population. Curr Med Res Opin. 2023;39(1):47-61.
- Greene M, Dore M, Ebner DW, et al. Real-world multi-target stool DNA longitudinal adherence for colorectal cancer re-screening in a large, nat’l population. J Clin Oncol. 2024;42(16):e15633.
-
Gervès-Pinquié, C., Girault, A.,
Phillips , S. et al. Economic evaluation of patient navigation programs in colorectal cancer care, a systematic review. Health Econ Rev 8, 12 (2018). -
Data on file for coverage. Market Access. 2024. Exact Sciences Corporation.
Madison, WI.
About the Cologuard® and Cologuard Plus™ tests
Developed in collaboration with Mayo Clinic, the Cologuard® and Cologuard Plus™ tests are first-line, noninvasive 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 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. The Cologuard test and Cologuard Plus test are only available in the
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 the Cologuard Plus test and the performance characteristics and health care benefits of the Cologuard Plus test in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences’ pipeline tests. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250331788957/en/
Media Contact: Steph Spanos – 608-556-4380, sspanos@exactsciences.com
Investor Contact: Derek Leckow – 608-893-0009, investorrelations@exactsciences.com
Source: Exact Sciences Corp.
FAQ
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