The Qualifying Therapeutic Discovery Project was enacted as part of the health care reform legislation passed earlier this year.
In order to qualify under the program’s guidelines, Exact Sciences had to show reasonable potential to produce a new therapy to prevent, detect or treat chronic or acute disease and conditions; reduce long-term health costs; or advance the goal of curing cancer within a 30-year period.
The Cologuard sDNA test would work by detecting specific altered DNA sequences in cells that are shed into the stool from pre-cancerous or cancerous polyps, Exact Sciences said.
The latest American Cancer Society colorectal cancer screening guidelines include the sDNA form of testing as a recommended screening option.