Exact Sciences' experience with the FDA and CMS parallel review program.
Expert Rev Mol Diagn
; 15(9): 1117-24, 2015.
Article
em En
| MEDLINE
| ID: mdl-26211481
ABSTRACT
Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer death among men and women combined in the USA. Although the benefits of early CRC detection are widely recognized, screening rates are suboptimal. Cologuard is a multitarget stool DNA screening test that offers a unique non-invasive option for CRC screening. Cologuard was the first product to be reviewed under a pilot parallel review program jointly conducted by the US FDA and the Centers for Medicare & Medicaid Services (CMS). This parallel review process shortened the overall review for Cologuard and resulted in a preliminary National Coverage Determination that coincided with FDA approval.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Centers for Medicare and Medicaid Services, U.S.
/
Revisão da Utilização de Recursos de Saúde
Tipo de estudo:
Diagnostic_studies
/
Screening_studies
Limite:
Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article