Case Study
At-Home Wellness Company
“BurstDX’s ability to adapt to new assay chemistries is matched only by their commitment to timely delivery. Whether responding to emerging scientific demands or evolving needs, BurstDX has consistently pivoted with precision and without missing a beat.”
- CEO/Founder, Anonymous Partner
The Challenge
A wellness company developing a biomarker monitoring solution approached BurstDX to build a diagnostic assay platform that combined lab-level sensitivity and quantification with the speed and simplicity required for decentralized testing.
Traditionally, quantitative assays for these biomarkers rely on hours-long competitive and sandwich immunoassays performed in centralized labs, limiting accessibility and delaying patient results. Our partners needed more than a quick result. They needed a platform that could deliver clinical-grade lab performance in a user-friendly format that was feasible for at-home use.
Our Role
Key Activities
The Impact
BurstDX was selected as the assay development partner based on the CaDI’s proven ability to quantify low pg/mL concentrations, surpassing the sensitivity of traditional lateral flow assays.
BurstDX led the end-to-end development of four single-plex assays, including antibody screening and selections, assay optimization, analytical validation, and assay design to enable a future multiplexed test. The objective was to create a solution that delivered clinical-grade quantification while maintaining the simplicity and sub-15-minute results required for potential consumer-facing applications.
Screened antibody candidates using Western blot and CaDI to identify high-affinity capture/detection pairs for optimal sensitivity.
Developed four single-plex assays optimized to meet required sensitivity and performance criteria within clinically relevant ranges.
Designed assays with future multiplexing and biological matrix compatibility in mind.
Conducted cross-reactivity assessments to ensure target specificity for future multiplexing.
Achieved target time-to-result of under 15 minutes without compromising analytical performance.
Facilitated weekly progress updates to ensure alignment and respond to evolving partner needs.
BurstDX delivered four single-plex assays that met or exceeded partner benchmarks for sensitivity, specificity, and speed.
The project demonstrated CaDI’s ability to translate lab-based competitive & sandwich immunoassay performance into a rapid format while maintaining accuracy in clinically relevant ranges.
This successful collaboration laid the groundwork for expanded development, including multiplexed panels and integration with diverse biological matrices, moving our partner closer to realizing their long-term vision for accessible biomarker monitoring.
