Portable Immunoassay System Advances Toward Point-of-Care Biomarker Testing

Image: The technology combines a disposable cartridge with a compact reader to perform immunoassays with central-lab performance closer to the bedside (Photo courtesy of Proxim Diagnostics)

Proxim Diagnostics Corp. (Santa Clara, CA, USA) has announced that its Profile System, a handheld point-of-care immunoassay platform, has completed development. The milestone includes completion of the reader, single-use cartridge, and initial manufacturing capability. The fully automated, portable system is designed to deliver high-sensitivity biomarker testing at the point of care and is now positioned for production readiness and potential partnerships in acute care and research applications.

The technology integrates a disposable cartridge with a compact reader to execute immunoassays intended to deliver centralized laboratory performance closer to the bedside. The Profile System is designed as a flexible architecture capable of supporting multiple assay types on the same handheld reader. The company indicates this may enable a broad test menu over time, including research‑use‑only (RUO) assays for biopharma customers and future clinical assays that would be subject to applicable regulatory requirements.

Proxim is advancing applications in acute care biomarkers, including cardiac and inflammatory markers where rapid point‑of‑care results can support time‑critical decisions. The platform has demonstrated key analytical traits associated with high‑sensitivity troponin testing. In testing of its high‑sensitivity troponin I assay, the system achieved an 81% detectable rate in the normal population.

The company also highlights RUO assays for cytokines such as interleukin‑6, interferon‑gamma, and CXCL9 for inpatient and outpatient use by biopharma clients developing T‑cell engager therapies, where rapid cytokine measurements may support prediction, monitoring, and management of cytokine release syndrome (CRS), immune effector cell‑associated neurotoxicity syndrome (ICANS), hemophagocytic lymphohistiocytosis (HLH), and other immuno‑oncology therapy‑related adverse effects.

“Completing development of our handheld reader, cartridge, and initial manufacturing capacity is a major milestone for Proxim. We now have a fully developed product platform that is ready to support high-value clinical and RUO opportunities,” said Mikhail Briman, Ph.D., CEO and co-founder of Proxim Diagnostics.

“Our goal has always been to bring the sensitivity and precision of centralized laboratory testing into a portable point-of-care format, and this achievement puts us in a strong position to engage strategic partners and customers across biopharma, acute care, women’s health, and other important clinical and research areas,” added Briman.

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