Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration (FDA) the first module of the premarket approval (PMA) application for its stool DNA colorectal cancer screening test.
The first modular application includes information about assay’s manufacturing process and quality control systems used during production.
Exact Sciences president and chief executive Kevin Conroy said on completion of work on the first module, the company will submit the analytical and clinical modules.
"The submission of the first, manufacturing module of our PMA application is an important milestone for the company," Conroy added.
The FDA has up to 45 days to accept the submission, claims the company.