Exact Sciences Corporation: PMA supplement approved for Cologuard Plus
Exact Sciences Corporation (Madision, Wisconsin): PMA supplement approved for Cologuard Plus. Dated 162 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 4 related WI FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Exact Sciences Corporation |
| Product | Cologuard Plus |
| Generic / ingredient | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Approval | PMA supplement (device change) |
| Application | P230043 S006 |
| Decided | 2026-05-27 |
| Panel / class | Pathology |
| Sponsor location | Madision, WI |
| Peer records CSV (5 WI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-05-27
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (WI first): Promega Corporation · Exact Sciences Corporation · Exact Sciences Corporation · Merz North America, Inc. · Instylla, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Exact Sciences Corporation and 5 Wisconsin peers
- Wisconsin FdaApprovalPulse records like this one: 5
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Exact Sciences Corporation in Madision, Wisconsin?
The FDA approved Cologuard Plus (P230043 S006) for Exact Sciences Corporation on 2026-05-27: PMA supplement (device change).
How does Exact Sciences Corporation compare to other Wisconsin FdaApprovalPulse records?
It is 162 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Exact Sciences Corporation vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Exact Sciences Corporation | Madision, WI | 2026-05-27 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.