Exact Sciences Corp. 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.

The retrospective, case-control study included cancers from 11 organ sites with no recommended screening option 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 deathsii, with no recommended screening tests available for 70% of cancer diagnoses. 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.

iii 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 large 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.