Exact Sciences data from a multi-cancer early detection (MCED) biomarker validation study was presented at the European Society for Medical Oncology (ESMO) Congress.
Multi-Biomarker Approach Achieves 61 Percent Sensitivity for Cancer at an Overall Specificity of 98.2 Percent in Robust Case-Control Study Including Nearly 600 Cancer Samples.
Data will Inform the Largest Registrational Multi-Cancer Early Detection Study Ever Conducted in the United States to Support Another Leading Test in Exact Sciences’ Screening Portfolio.
MADISON, Wis., Sept. 10, 2022 – Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced data from a multi-cancer early detection (MCED) biomarker validation study was presented at the European Society for Medical Oncology (ESMO) Congress. The study rigorously assessed the performance of four distinct biomarker classes found in the blood and known to signal the presence of cancer regardless of its location in the body.
“Cancer releases a diverse set of biomarkers into the blood that can be harnessed to detect the devastating disease at earlier stages,” said Tom Beer, M.D., F.A.C.P., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. “These data demonstrate in a large, well-designed case-control study that combining different cancer biomarkers improves cancer detection, especially in stages I and II, when treatment may be more effective for patients. This is a major step forward in our mission to detect cancer earlier before signs and symptoms appear.”
Four biomarker classes, discovered through years of collaboration with Johns Hopkins and Mayo Clinic and analyzed together for the first time in this study, demonstrated the ability to detect cancer signal from 15 organ sites with a mean sensitivity of 61% and mean specificity of 98.2%. The multi-biomarker approach, including aneuploidy, proteins, and DNA methylation and mutations, provided encouraging cancer detection in stages I and II, with a combined sensitivity of 38.7%.
Sensitivities by Cancer Stage for Four-Biomarker Class Set
| Stage | Sensitivity |
| I | 31.4 % |
| II | 45.8 % |
| I+II | 38.7 % |
| III | 68.3 % |
| I+II+III | 49.8 % |
| IV | 87.1 % |
The retrospective, case-control study included cancers from 11 organ sites with no recommended screening option today and 15 organ sites and tissue in total, including breast, bladder, colon, esophageal, kidney, liver, lung, multiple myeloma, myelodysplastic syndrome, non-Hodgkin’s lymphoma, ovarian, pancreatic, prostate, stomach, and uterine. The non-cancer control cohort included age-matched, presumably healthy individuals and samples from individuals with non-cancer diseases to represent the intended use population more effectively.
Many cancers can be cured if detected early and treated effectively. Yet cancer remains the second leading cause of death worldwide, accounting for approximately 1 in every 6 deaths, with no recommended screening tests available for 70 percent of cancer diagnoses.
“Being able to screen patients for multiple cancers with a blood test, especially those that don’t have a current screening option, is extremely exciting,” said Anne Marie Lennon M.B.B.Ch., Ph.D. Director, Division of Gastroenterology and Hepatology and Professor of Medicine at Johns Hopkins Medicine. “Robust studies like this one are important in understanding the potential effectiveness of a multi-biomarker approach to MCED. This study shows encouraging signs that cancers, including early-stage cancers, can be detected, providing us the opportunity to improve patient outcomes by treating the disease when it is typically most responsive to therapy.”
The study presented at ESMO builds on the insights and experience gained from earlier versions of the MCED test used in the DETECT-A study. DETECT-A, the first and only prospective, interventional study of 10,000 women to screen for multiple cancers, demonstrated the ability of an MCED test to more than double the number of screening-detected cancers compared to standard-of-care screening methods alone.
A larger case-control study is underway to further validate the results shared at ESMO and determine the final design of the MCED test. Exact Sciences will then begin recruiting patients for the FDA registrational Study Of All comeRs (SOAR) trial in MCED during 2023. The SOAR trial will be the largest prospective, interventional MCED trial ever conducted in the United States. Exact Sciences plans to leverage its leading presence in primary care and cancer screening to accelerate the availability of MCED and deliver this powerful innovation to patients in need.