This section highlights FDA-related milestones and regulatory updates for drugs developed by Exact Sciences (EXAS).
Over the past two years, Exact Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Cologuard, Cologuard, colorectal, Oncodetect™, and Oncotype. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Cologuard - FDA Regulatory Timeline and Events
Cologuard is a drug developed by Exact Sciences for the following indication: For Treatment of Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cologuard
- Announced Date:
- April 29, 2025
- Indication:
- For Treatment of Cancer
Announcement
Exact Sciences Corp announced the company will present 15 abstracts during Digestive Disease Week (DDW) 2025, taking place May 3-6, 2025, in San Diego, California.
AI Summary
Exact Sciences Corp. will present 15 research abstracts at Digestive Disease Week (DDW) 2025, scheduled for May 3–6 in San Diego, California. The studies emphasize the performance of the Cologuard® test—a noninvasive colorectal cancer screening option for average-risk adults aged 45 and older. Data from over half a million patients will support findings on high adherence and a strong predicted preference for Cologuard, indicating its effectiveness across various demographic groups. The abstracts will cover topics such as patient screening preferences and follow-up adherence after positive stool tests, offering a detailed look at real-world screening behaviors. As DDW is a premier event for professionals in gastroenterology and related fields, this presentation highlights Exact Sciences’ commitment to advancing early cancer detection and addressing screening challenges through innovative research.
Read Announcement- Drug:
- Cologuard
- Announced Date:
- January 21, 2025
- Indication:
- For Treatment of Cancer
Announcement
Exact Sciences Corp announced that it will present 11 abstracts at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) meeting January 23-25, 2025, in San Francisco.
AI Summary
Exact Sciences Corp announced that it will present 11 abstracts at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, scheduled for January 23–25, 2025. The abstracts will highlight new data on the performance of its Oncodetect molecular residual disease (MRD) test, which has shown strong sensitivity and specificity in detecting cancer recurrence across various stages, including stage III colon cancer and extending to stages II, IV, and rectal cancer.
This presentation at ASCO GI underlines the company’s commitment to improving cancer detection and monitoring. With plans to launch the Oncodetect test in the second quarter of 2025 backed by Medicare coverage, Exact Sciences is positioning itself as a leader in personalized oncology solutions. The symposium will provide healthcare professionals a closer look at the data supporting the test’s robust performance and potential impact on patient care.
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Cologuard test - FDA Regulatory Timeline and Events
Cologuard test is a drug developed by Exact Sciences for the following indication: For CRC screening.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cologuard test
- Announced Date:
- August 15, 2024
- Indication:
- For CRC screening
Announcement
Exact Sciences Corp. today describing the projected impact of the Cologuard test on patients, health care professionals, and the U.S. health care system since its FDA approval 10 years ago.
AI Summary
Exact Sciences Corp. presented new modeling data showing the impressive impact of the Cologuard test since its FDA approval 10 years ago. The data reveal that over 16 million Cologuard screenings have been completed, with the test detecting a significant number of advanced precancerous lesions and early-stage colorectal cancers. By identifying cancers early, many patients have been spared invasive treatments like chemotherapy or radiation. The test has played a key role in increasing colorectal cancer screening rates in the U.S., especially among average-risk adults who might otherwise be missed by traditional colonoscopy methods.
In addition to improving patient outcomes, the Cologuard test has eased the burden on the U.S. health care system by saving millions of work hours for providers and contributing to over $22 billion in health care cost savings. This success has paved the way for further innovations as a next-generation version of the test is under FDA review.
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colorectal cancer (CRC) - FDA Regulatory Timeline and Events
colorectal cancer (CRC) is a drug developed by Exact Sciences for the following indication: Multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively-collected cohor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- colorectal cancer (CRC)
- Announced Date:
- September 16, 2024
- Indication:
- Multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively-collected cohor
Announcement
Exact Sciences Corp announced performance data for its blood-based colorectal cancer (CRC) screening test. Results show sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
AI Summary
Exact Sciences Corp. recently announced encouraging performance data for its new blood-based colorectal cancer (CRC) screening test. The test showed a sensitivity of 88.3% for detecting colorectal cancer and 31.2% for identifying advanced precancerous lesions, while maintaining a specificity of 90.1% when negative results were confirmed by colonoscopy. This innovative approach uses a unique panel of methylated DNA markers, improving detection capabilities for both cancer and high-risk lesions. The study was designed to simulate the screening population in the United States and reflects the company’s commitment to closing the screening gap through advanced diagnostics. By offering another non-invasive screening option, Exact Sciences aims to benefit millions of individuals who currently go unscreened, and this progress could boost early detection efforts and ultimately improve patient outcomes.
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Oncodetect™ - FDA Regulatory Timeline and Events
Oncodetect™ is a drug developed by Exact Sciences for the following indication: Molecular Residual Disease Test.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Oncodetect™
- Announced Date:
- July 9, 2025
- Indication:
- Molecular Residual Disease Test
Announcement
Exact Sciences Corp announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period.
AI Summary
Exact Sciences Corp announced that its Oncodetect™ molecular residual disease (MRD) test has now received Medicare coverage by the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX). This approval allows for the serial use of the test over a five-year period in patients with stage II, III, and resectable stage IV colorectal cancer (CRC), specifically in the adjuvant and recurrence monitoring settings. The decision underlines the clinical value of the assay, which is designed to track up to 200 circulating tumor DNA (ctDNA) variants and offer early detection of cancer recurrence—often up to two years sooner than imaging methods.
This milestone reflects Exact Sciences’ commitment to enhancing cancer treatment by providing earlier, more personalized insights during critical stages of care. The company hopes that this coverage will increase patient access and support informed treatment decisions in colorectal cancer care.
Read Announcement- Drug:
- Oncodetect™
- Announced Date:
- April 22, 2025
- Indication:
- Molecular Residual Disease Test
Announcement
Exact Sciences Corp. announced the launch of Oncodetect™—a new test designed to detect molecular residual disease (MRD) across multiple solid tumors.
AI Summary
Exact Sciences Corp. has launched Oncodetect™, a new test designed to detect molecular residual disease (MRD) across multiple solid tumors. Oncodetect uses a tumor-informed approach to track up to 200 tumor-specific ctDNA variants, offering high sensitivity to detect even tiny traces of cancer cells. This breakthrough test can identify signs of cancer recurrence—especially in colorectal cancer—up to two years earlier than traditional imaging methods.
The test provides simple “Detected” or “Not Detected” results along with quantitative data to aid healthcare providers in making better treatment decisions. By offering early insights and personalized information, Oncodetect empowers both patients and doctors to choose more informed and timely treatment options, enhancing the overall management of cancer care.
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Oncotype DX Breast Recurrence Score - FDA Regulatory Timeline and Events
Oncotype DX Breast Recurrence Score is a drug developed by Exact Sciences for the following indication: Chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Oncotype DX Breast Recurrence Score
- Announced Date:
- April 14, 2025
- Indication:
- Chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive
Announcement
Exact Sciences Corp. announced the publication of a comprehensive review in JAMA Oncology that strengthens the evidence supporting the Oncotype DX Breast Recurrence Score test.
AI Summary
Exact Sciences Corp. recently announced the publication of a comprehensive review in JAMA Oncology that supports the use of the Oncotype DX Breast Recurrence Score test. This review shows that the test reliably predicts breast cancer outcomes and helps determine which patients will benefit from chemotherapy. The study confirms that the test works well for all racial and ethnic groups, providing accurate insights that assist in making informed treatment decisions. The findings emphasize that even though there are differences in breast cancer outcomes among different groups, the Oncotype DX test consistently offers clear and reliable results. This strengthens confidence in using this genomic assay as an important tool in precision oncology, ensuring that every patient receives treatment based on dependable data.
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