Company intelligence / Profile preview

AmplifiDx

Ownership: Private
Development stage: Commercial

Overview

AmplifiDx’s COVID‑19 assay on the DX 1000 System demonstrated a positive percent agreement of 97.8% and negative percent agreement of 100% compared to the Roche cobas liat system in clinical studies. The platform can deliver results within approximately 20–30 minutes and is designed for point-of-care use with minimal hands-on time. Not yet FDA cleared or approved as of June 2025

Therapeutic areas: Infectious Diseases
Modalities: DeviceNucleic acid amplification test (NAAT)Molecular diagnostics platform
Industry: Molecular Diagnostics

Drug pipeline

2 assets

DX 100 Platform

Commercial

Indications: Sexual health, Family health, Women's health

1 more asset in the full pipeline.

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Partnerships

National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering RADx Tech program

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