Kompass Diagnostics has been selected as a recipient of the NIH-supported POCTRN Innovation Award through the Atlanta Center for Microsystems-Engineered Point-of-Care Technologies (ACME POCT). This award recognizes emerging companies developing transformative diagnostic platforms that can decentralize testing and bring lab-quality results directly to patients and providers.
ACME POCT’s mission is to accelerate high-impact, microsystems-based point-of-care technologies that enable patient-centered, accessible care. Kompass Diagnostics was selected for its IDA platform, a novel high-sensitivity electrochemical system that combines enzyme-driven signal generation with semiconductor-based sensors. Compared to conventional chemiluminescence assays, the IDA platform offers a unique combination of simplicity, stability, miniaturization, and cost-effectiveness while maintaining analytical sensitivity on par with central laboratory methods.
“Our solution aligns directly with ACME’s mission to advance microsystems-based diagnostics that push care closer to the patient,” said Mingoo Kim, CEO of Kompass Diagnostics. “By enabling rapid hormone testing from a finger prick sample, we aim to transform the most time-consuming and resource-intensive part of fertility care into something that can be done at home or in decentralized clinics.”
The collaboration with ACME POCT will provide Kompass with specialized expertise in microfluidic and device engineering, human factors design, and third-party clinical validation. Specifically, Kompass will work with ACME to refine its prototype cartridge-and-reader system to advance towards mass manufacturing. The company will also collaborate with ACME’s Human Factors Design Center to optimize the test workflow, UI/UX, and overall user experience for patients and clinicians.
In addition, ACME POCT will support Kompass in analytical validation, running blinded studies on patient samples to benchmark accuracy, precision, and usability against gold-standard methods. Regulatory experts at ACME will also collaborate with the Kompass team to review current FDA strategies, refine claims and documentation, and map out a dual-track 510(k) and CLIA-waiver regulatory pathway.
Currently, Kompass Diagnostics has validated a proof-of-concept prototype in clinical serum, secured $1.6 million in seed funding and a $305,000 NSF SBIR Phase I award, and submitted a 513(g) filing to the FDA to define its regulatory pathway. The NIH POCTRN Innovation Award marks a critical inflection point for the company as it transitions from lab-scale development to product design freeze and pilot manufacturing.
“The expertise at ACME POCT fills a critical gap for early-stage diagnostic innovators like us,” Kim added. “With their engineering, validation, and regulatory support, we are well positioned to accelerate our path toward making fertility diagnostics more accessible, affordable, and patient-centered.”
