# Simoa

Type: Product

Source: GetYourBrief — https://getyourbrief.com/entity/simoa
Canonical HTML page: https://getyourbrief.com/entity/simoa

## Timeline

- **2026-03-02**: Earnings Call — Management confirms CMS reimbursement rate of $897 and 2025 assay expansion.
- **2026-03-02**: Q4 2025 Earnings — Company reports 25% total revenue growth and progress in clinical diagnostic pivot.
- **2026-01-15**: FDA Submission — 510(k) premarket notification submitted for Lucent AD Complete.
- **2026-01-15**: FDA 510(k) Submission — Premarket notification submitted for Lucent AD Complete diagnostic test.
- **2025-12-31**: Q4 2025 Close — Quanterix reports $43.9M in revenue with 25% YoY growth.
- **2025-12-31**: CMS Reimbursement Milestone — CMS approves $897 reimbursement rate for Lucent AD Complete, establishing a national reference price.
- **2025-01-01**: Assay Portfolio Expansion — Launch of 13 new assays including pTau-205 and pTau-212 for neurodegenerative research.

## Recent coverage (2 stories, network-wide)

### Quanterix Advances Alzheimer’s Strategy Amidst 25% Revenue Growth and FDA Filing
2026-03-04 00:21:33 · Sector: bio · Sentiment: Positive · Impact: 6/10 · Sources: 6

Quanterix reported Q4 2025 revenue of $43.9 million, driven by a 25% year-over-year increase and significant progress in its Alzheimer’s diagnostic portfolio. Despite organic declines in its core Simoa and Spatial segments, the company secured a $897 CMS reimbursement rate for its Lucent AD Complete test and submitted its 510(k) to the FDA.
Full story: https://getbiobrief.com/story/quanterix-q4-2025-alzheimers-diagnostic-strategy-fda-filing

### Quanterix Secures CMS Reimbursement for Alzheimer’s Test Amid Q4 Growth
2026-03-04 00:20:22 · Sector: health · Sentiment: Positive · Impact: 6/10 · Sources: 6

Quanterix reported a 25% year-over-year revenue increase to $43.9 million in Q4 2025, driven by a surge in diagnostics partner revenue and critical regulatory milestones. The company achieved a commercial breakthrough with a $897 CMS reimbursement rate for its Lucent AD Complete test, positioning it for large-scale clinical adoption.
Full story: https://gethealthbrief.com/story/quanterix-q4-2025-alzheimers-diagnostics-milestone

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