Exact Sciences Corporation has unveiled groundbreaking data regarding its multi-cancer early detection (MCED) blood test. Presented at the American Association for Cancer Research’s annual meeting in San Diego, the test has achieved a sensitivity of 50.9% at an impressive specificity of 98.5% across 21 different cancer types. This represents an advancement in cancer detection technology, particularly in identifying cancers with the shortest five-year survival rates, such as lung, ovarian, and pancreatic cancers, where sensitivity increased to an impressive 63.7%.
Exact Sciences’ MCED test is set apart by its utilization of methylation and protein biomarkers to capture shared, cancer-associated signals, eliminating the need for costly next-generation sequencing. Analysts have noted the potential cost-effectiveness of this approach compared to sequencing-based products like Grail’s Galleri. Exact Sciences utilized a large dataset of over 3,000 samples for training and an additional 3,200 samples for testing, demonstrating the robustness of its methodology. Exact Sciences’ MCED test has demonstrated potential in identifying cancers without standard-of-care screening methods. Sensitivity reached 54.8% for cancers lacking standard-of-care screening in average-risk populations. This shows the test’s ability to address gaps in current screening modalities, particularly for cancers where early detection is challenging due to the absence of effective screening tools.
The sensitivity of the MCED test varied across different cancer types and stages. Sensitivity reached its peak at 63.7% for the most aggressive cancers with the shortest five-year survival rates, including pancreatic, esophageal, liver, lung, stomach, and ovarian cancers. Sensitivity also correlated with cancer stage, ranging from 15.4% for Stage 1 to 85.5% for Stage 4 cancers in the overall dataset. These findings show the potential of MCED in detecting cancers at earlier, more treatable stages. Despite the promising results, progress towards a registrational clinical trial has been hindered by legislative issues. Exact Sciences has scaled back its investment in MCED due to the lack of explicit Medicare authority to pay for such tests. CEO Kevin Conroy emphasized the company’s stance, citing the need for legislative action to facilitate broader access to MCED testing. This regulatory barrier outlines the challenges in translating innovative technologies from the laboratory to clinical practice.
In addition to the ASCEND-2 study, Exact Sciences also presented outcomes from DETECT-A, a prospective study involving over 10,000 participants. The MCED test detected pre-cancerous conditions in some cases, leading to successful interventions and cancer prevention. These real-world outcomes highlight the potential clinical utility of MCED testing in identifying pre-malignant conditions and guiding early interventions to reduce cancer morbidity and mortality.
Exact Sciences aims to advance its Cancerguard™ test, a multi-biomarker class MCED test designed to detect multiple cancers in their earliest stages from a single blood draw. Leveraging a streamlined diagnostic pathway and high specificity, the Cancerguard™ test holds promise in revolutionizing cancer screening and early detection efforts. As Exact Sciences continues to innovate in the field of cancer diagnostics, collaborations with regulatory authorities and policymakers will be necessary to ensure the timely translation of these advancements into clinical practice.