Proxim Diagnostics completes development of handheld diagnostic platform

Proxim Diagnostics Corp. said it has completed development of its Profile point-of-care diagnostic platform, finishing work on the handheld reader, disposable cartridge and initial manufacturing capacity.

The milestone moves the Santa Clara-based company out of the product development phase and into production readiness, positioning it to pursue clinical trials and partnerships with biopharma companies, hospitals and other health care customers.

"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, referring to research use only applications. "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."

The Profile System runs immunoassays on disposable cartridges using a portable, fully automated reader that the company says can match the sensitivity and precision of centralized laboratory equipment. Proxim is targeting applications in several clinical areas, including oncology drug monitoring, cardiac care and women's health.

Among the near-term commercial targets, Proxim is marketing research-use assays for cytokines including IL-6, IFN-gamma and CXCL9 to biopharmaceutical companies developing T-cell engager therapies. Rapid cytokine measurement at the point of care may help clinicians predict and manage serious side effects of those therapies, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

The company also disclosed performance data for its high-sensitivity troponin I assay, a key marker used to diagnose heart attacks. Proxim said the assay detected troponin in 81% of a normal, healthy population — a threshold the company said places the system among the leading point-of-care options for the test.

The Profile platform is designed to support multiple assay types on the same reader, which Proxim said could allow the company to expand its test menu over time for both research and, subject to regulatory clearance, clinical use.