Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus
FDA premarket approval P230043 · decided 2024-10-03
Approval details
- PMA number
- P230043
- Trade name
- Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2023-12-22
- Decision date
- 2024-10-03
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Madision, WI
- Statement
- A qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia-associated DNA markers and for the presence of occult hemoglobin in human stool. The Cologuard Plus test is performed on samples collected using the Cologuard Plus Collection Kit. A positive result may indicate the presence of colorectal cancer (CRC) or advance precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard Plus test is indicated to screen adults 45 years or older who are
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