QTRX biotech catalysts & pipeline

QUANTERIX CORP · Data as of 2026-09-08

Upcoming catalysts

510(k) application — Regulatory decision

H2 2026

Additionally, our Alzheimer's diagnostics business continues its rapid growth with several key milestones expected in the second half of this year, including the completion of three clinical utility studies and a decision from the FDA on our 510(k) application.

Source filing

three clinical utility studies — Topline data

H2 2026

Additionally, our Alzheimer's diagnostics business continues its rapid growth with several key milestones expected in the second half of this year, including the completion of three clinical utility studies and a decision from the FDA on our 510(k) application.

Source filing

HD‑X platform — Regulatory decision

in 2027

We are also increasing our strategic focus on Alzheimer's diagnostics by hiring an experienced leader to oversee our diagnostics business, upgrading our HD‑X platform with the intent to pursue FDA in vitro diagnostics ("IVD") status in 2027, and investing in laboratory infrastructure and targeted commercial programs.

Source filing

HD-X platform — NDA/BLA submission

2027

To help fund these investments, we streamlined our product roadmap and commenced upgrading our HD-X platform with the intent to pursue FDA in vitro diagnostics ("IVD") status in 2027.

Source filing

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