Data presented at 2023 American Association for Clinical Chemistry Annual Scientific Meeting
Multi-site clinical study of 237 donors shows Truvian’s results are concordant with central laboratory analyzers
Data demonstrates Truvian’s technology is reproducible and meets linearity and sensitivity specifications for a wide range of assays
SAN DIEGO, July 25, 2023 — Truvian Health (“Truvian”) , a transformational and data-driven diagnostics company, today presented results from a recent multi-site clinical study at the 2023 American Association for Clinical Chemistry Annual Scientific Meeting demonstrating the ability of its benchtop blood testing platform to deliver central laboratory quality results simultaneously across a large panel of assays
“For the first time in our industry, we have demonstrated that central lab quality results across three testing technologies are achievable on a benchtop platform from a single tube of blood”
Data presented include results of a multi-site method comparison study of 237 donor samples run on both Truvian’s platform and central laboratory analyzers. The sample population consisted of apparently healthy donors (49%), donors with chronic disease (43%) and contrived samples (8%). Truvian’s platform showed excellent agreement to central laboratory analyzers in almost all assays in its panel.
“For the first time in our industry, we have demonstrated that central lab quality results across three testing technologies are achievable on a benchtop platform from a single tube of blood,” said Dena Marrinucci, Ph.D., co-founder and chief operating officer of Truvian. “We aim to bring the central lab closer to patients. In doing so, we believe Truvian’s solution will empower greater interactions between patients and healthcare providers.”
Added Jay Srinivasan, chief executive officer of Truvian, “The data we continue to generate in the field, and within Truvian has demonstrated the art of the possible in decentralized blood diagnostics. We believe our platform can have a significant impact on the healthcare system by bringing accurate, convenient and transparent blood testing to the point-of-action where patients and healthcare providers engage. With reliable results available in minutes, we hope to spur interactions that identify chronic disease before it begins and empower individuals toward longer, healthier living. We are excited about the significant progress we’ve made and look forward to finishing the development of our product based on these results and additional upcoming studies.”
At AACC, Truvian also presented results from a reproducibility study to evaluate performance of multiple machines over multiple days. The study assessed variance of its technology with multiple replicates of low, normal and high-level controls run on three different machines over a five-day period. Truvian’s platform achieved acceptance criteria for 99% of 25 assays evaluated, with just a single outlier observed in 4,500 results from 180 runs.
Additional data included in the poster demonstrated linearity and sensitivity achieved across clinically relevant measuring ranges. Among the assays highlighted, most notably, Truvian’s technology can detect low abundance targets like thyroid stimulating hormone (TSH) with data that supports a lower limit of quantitation on par with third generation TSH assays. More study data was included in the poster and will be available on Truvian’s corporate website following AACC.
Truvian’s Platform leverages three commonly used testing technologies – immunoassay, clinical chemistry, and hematology to simultaneously perform routine blood testing in minutes from a small sample of blood. With an initial testing panel of more than 30 assays, the Truvian Platform can run the most commonly ordered tests that account for greater than 90% of blood test orders. This fully automated solution has been designed to use pre-packaged single use test kits, with minimal maintenance needed to ensure the technology can be used consistently and reliably anywhere.
Truvian is a transformational diagnostic company bringing lab-accurate results to the point-of-action where consumers engage healthcare providers to lead healthier lives. With a focus on making routine blood testing accessible, convenient, and transparent, Truvian is accelerating the transition to a sustainable healthcare ecosystem through its comprehensive benchtop solution that delivers timely, actionable results to help stop disease before it starts. For more information, visit truvianhealth.com.