Exact Sciences Launches Oncodetect™ MRD Test
Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics and screening, has officially launched Oncodetect™, a next-generation test designed to detect molecular residual disease (MRD) in patients with solid tumors. The new test marks a significant step forward in precision oncology, offering both patients and healthcare providers critical information to guide decisions across the continuum of cancer care.
Oncodetect delivers straightforward results—either “Detected” or “Not Detected”—along with quantitative measurements that help assess the presence of circulating tumor DNA (ctDNA) in the bloodstream. These insights enable more informed decisions regarding adjuvant therapies, treatment response evaluations, and early detection of recurrence. Clinical evidence suggests that patients who test positive for ctDNA using Oncodetect during surveillance are up to 50 times more likely to experience a cancer recurrence compared to those with negative results¹.
The test is built for high sensitivity and personalization, tracking up to 200 tumor-specific variants unique to each patient’s cancer. This tumor-informed approach allows Oncodetect to detect extremely small quantities of ctDNA—down to one tumor molecule per 20,000 fragments of cell-free DNA (cfDNA)‡—enhancing the ability to catch recurrences earlier than traditional imaging can².
“Exact Sciences is committed to changing the course of cancer care,” said Brian Baranick, Executive Vice President and General Manager of Precision Oncology at Exact Sciences. “After surgery and treatment like chemotherapy or radiation, the risk of cancer returning is a major concern. With Oncodetect, we’re giving physicians advanced tools to identify that risk early and tailor treatments to each individual’s needs.”
Clinical Validation and Reimbursement Progress
Oncodetect is supported by extensive clinical validation, including results from the Alpha-CORRECT study, one of the longest-running studies of MRD in colorectal cancer (CRC). With nearly five years of patient follow-up, the study provides compelling data on the predictive power of MRD testing and its ability to improve outcomes through earlier intervention.
Exact Sciences is currently working with Medicare to obtain reimbursement for Oncodetect, an important step in making the test more broadly accessible. In parallel, the company is expanding validation efforts across multiple solid tumor types, backed by strategic partnerships focused on generating robust, multi-cancer evidence.
Patient Empowerment and Advocacy
For many patients, particularly those living with the uncertainty of recurrence, MRD testing brings a new level of clarity and reassurance.
“Exact Sciences has long been a trusted partner in colorectal cancer care,” said Vanessa Ghigliotty, Certified Patient Navigator and Chair of the Patient Advisory Board at the GI Cancers Alliance. “For patients navigating life after treatment, Oncodetect provides timely and accurate information—empowering them to be proactive and make informed decisions about their care.”
Integration with Digital and Genomic Testing Platforms
Oncodetect is part of Exact Sciences’ growing portfolio of precision oncology tools. It integrates with ExactNexus™, the company’s digital technology platform, making it easy for physicians to order and manage test results. Oncodetect can also be used alongside other Exact Sciences offerings, such as OncoExTra® (comprehensive genomic profiling) and Riskguard® (hereditary cancer testing), creating a streamlined experience for clinicians and patients alike.
The launch of Oncodetect builds on two decades of genomic testing expertise at Exact Sciences, particularly through its widely adopted Oncotype DX Breast Recurrence Score® test, which has helped guide treatment for thousands of breast cancer patients worldwide.
Meeting a Growing Demand
With over 3 million U.S. patients currently eligible for MRD testing³, Exact Sciences is strategically positioned to meet rising demand and continue shaping the future of personalized cancer care. The company’s focus on innovation, clinical validation, and accessibility signals a new era where earlier detection and data-driven decisions play a central role in improving patient outcomes.
About Exact Sciences
Exact Sciences Corp. is a leading provider of cancer screening and diagnostic tests, focused on delivering innovative solutions across the cancer care continuum. From early detection to post-treatment monitoring, Exact Sciences is transforming how cancer is detected, treated, and managed.
