SAN DIEGO — Truvian Health, a San Diego blood diagnostics company, shared data on Tuesday showing that its benchtop instrument’s results are largely consistent with those generated by large central laboratories. But while the results lend support for the company’s vision of decentralized and widely available clinical testing, they also resurface questions about the value of an approach widely associated with the now defunct and notorious Bay Area startup Theranos.
In a multisite study, the company tested nearly 240 blood samples from healthy donors and chronic disease patients for dozens of blood-based measurements commonly ordered by doctors, from cholesterol to blood sugar to blood cell counts. Results from Truvian’s benchtop analytical instrument, with few exceptions, closely matched readings from devices used in large central labs and made by Swiss pharma giant Roche and Japanese firm Sysmex.
The findings were presented at the annual meeting of the American Association for Clinical Chemistry, recently rebranded as the Association for Diagnostics & Laboratory Medicine. It’s the first time Truvian has shared clinical data on its product, though they have not been published in a peer-reviewed journal. The company, which is planning additional validation studies, expects to submit for Food and Drug Administration approval of its device by the third quarter of 2024.
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