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The results show that next-generation Cologuard® met all study endpoints, showing improved cancer sensitivity, specificity, and precancer sensitivity.
The company plans to complete the FDA submission by the end of 2023.
“Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time – when there are 60 million Americans not up to date with screening,” said CEO Kevin Conroy.