A San Diego company has earned FDA clearance for a device that could make blood testing easier.
Truvian Health’s device, TruVerus, uses a small amount of blood to return routine tests quickly. The company says its benchtop instrument could process tests “wherever care happens” — from clinics to pharmacies. Instead of sending vials of blood to a lab, these devices can report results in less than 30 minutes.
“Our goal is to make lab-quality diagnostics practical wherever care happens, reducing operational complexity and enabling faster, accurate decision-making,” Dr. Dena Marrinucci, Truvian’s co-founder and chief operating officer, told the Union-Tribune on Wednesday.
Currently, Truvian’s device is focused on blood tests to screen for kidney health. Plug in the tabletop device, and get lab-grade results in minutes, explained Marrinucci.
“Kidney-related biomarkers are among the most commonly ordered tests,” Marrinucci said. “Our initial FDA clearance includes blood urea nitrogen and creatinine, enabling eGFR determination, for a comprehensive kidney health assessment.”
TruVerus was cleared earlier this month through the FDA’s 510(k) process, meaning regulators found it performed on par with other devices already on the market. The FDA study compared TruVerus to Roche Cobas and Sysmex, according to Marrinucci.
This comparative technology uses larger devices that are traditionally found within clinical, commercial and hospital laboratories.
While the test results were similar, Marrinucci said nothing on the market can do what Truvian has created in a single compact system. “We’ve taken proven laboratory technologies, miniaturized them, and built smart workflows that deliver efficiency without complexity,” she said.
Beyond kidney health, Truvian has submitted additional panels for FDA review that include diabetes, thyroid, liver, lipids and hematology.
Marrinucci did not share a timeline for when the tests would come to market other than saying Truvian would have more details in the coming months.