A San Diego medical technology company received FDA approval this morning for a device that could transform how patients get blood tests done.
The FDA approved Truvian's new TruVerus machine, which can run nearly three dozen common blood tests right in a doctor's office. The approval means patients won't have to make separate appointments at labs and can receive results in minutes rather than days.
"What that enables us to do is very large, comprehensive panels without taking a lot of blood from a patient, and being able to deliver timely results while you're still with your healthcare provider," says Truvian Co-Founder and COO Dena Marrinucci.
Initial approval covers the device and blood testing of kidney functions. Truvia hopes to get more approvals on tests for cholesterol, immunoassays, hematology, and more in the coming months.
Since results come back in under 30 minutes, the device allows patients to discuss their test results with their doctor immediately during their appointment, eliminating the need for follow-up visits or waiting for email notifications.
"People don't regularly go get their blood tests done because it's inconvenient and it's not accessible and it costs money. So we've been working to bring down all of those barriers through this technology. We can now democratize blood testing," Marrinucci said.
"We believe through this technology, we'll be able to create more access and obviously, more convenience and more affordability for blood testing. That's really the foundation of what we need to live healthier and longer lives."
ABC 10News has followed Truvian since the company broke ground on its headquarters at UTC in 2019. The company submitted the TruVerus for FDA approval in 2024, marking a decade-long journey from startup to approved medical device.
"Like I tell a lot of people, there are no shortcuts in diagnostics," Marrinucci said. "At the end of the day, we're delivering results to patients; they have to be accurate. And so yes, it did take us more time to get it right, and that's been important, and kind of been our our truth from day one is to make sure that we get it right.
Truvian also represents a true San Diego success story, with their first investor, most founders, and many employees based locally in the region.
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