Simoa

Product

Last mentioned: Mar 4, 2026

Timeline

  1. Q4 2025 Earnings

    Company reports 25% total revenue growth and progress in clinical diagnostic pivot.

  2. FDA 510(k) Submission

    Premarket notification submitted for Lucent AD Complete diagnostic test.

  3. CMS Reimbursement Milestone

    CMS approves $897 reimbursement rate for Lucent AD Complete, establishing a national reference price.

  4. Assay Portfolio Expansion

    Launch of 13 new assays including pTau-205 and pTau-212 for neurodegenerative research.

Stories mentioning Simoa 1

pharma Bullish

Quanterix Advances Alzheimer’s Strategy Amidst 25% Revenue Growth and FDA Filing

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.

6 sources