Exact Sciences Corporation: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Exact Sciences Corporation”, plus 3 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | 2 | 0 |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 1 | 0 |
Review panels
- Pathology (3)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230043 | PMA | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus | 2024-10-03 |
| P210040 | PMA | RESOLUTION ctDx FIRST | 2022-12-12 |
| P130017 | PMA | COLOGUARD | 2014-08-11 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-04-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Exact Sciences Corporation is the lead sponsor of 8 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT07544680: Endometrial Cancer Vaginal Fluid Specimen Collection Study (Recruiting, started 2026-03-10)
- NCT06589310: Falcon Real World Evidence Registry (Recruiting, started 2024-08-01)
- NCT06398743: First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer (Active not recruiting, started 2023-06-20)
- NCT05210283: CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer (Active not recruiting, started 2021-12-15)
- NCT05064553: ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk (Active not recruiting, started 2021-07-26)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Exact Medical Manufacturing, Inc. (9 510(k)s)
- Exact Imaging, Inc. (4 510(k)s)
- Exact Science, Inc. (1 510(k)s)
- Exact Supplies , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Exact Sciences Corporation?
FDA lists 0 510(k) clearances under the applicant name “Exact Sciences Corporation”, plus 3 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Exact Sciences Corporation?
The most frequent FDA product codes under this applicant name are PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection, 2); PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 1).
Next steps
- See all 0 Exact Sciences Corporation clearances with predicates and recalls
- Run predicate analysis for product code PHP, Exact Sciences Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.