Michael Barbella, Managing Editor10.04.23
Truvian Health is sharing results from a recent multi-site clinical study that demonstrates the ability of its benchtop blood testing platform to deliver central laboratory quality results simultaneously across a large assay panel.
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,” Truvian Health Co-Founder/Chief Operating Officer Dena Marrinucci, Ph.D., said. “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.”
Truvian also released results from a reproducibility study to evaluate performance of multiple machines over multiple days. That 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 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.
“The data we continue to generate in the field, and within Truvian has demonstrated the art of the possible in decentralized blood diagnostics," Truvian Health CEO Jay Srinivasan stated. "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.”
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 diagnostic company bringing lab-accurate results to the point of action. With a focus on making routine blood testing accessible, convenient, and transparent, Truvian is accelerating the transition to a sustainable healthcare ecosystem through its benchtop solution that delivers timely, actionable results to help stop disease before it starts.
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,” Truvian Health Co-Founder/Chief Operating Officer Dena Marrinucci, Ph.D., said. “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.”
Truvian also released results from a reproducibility study to evaluate performance of multiple machines over multiple days. That 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 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.
“The data we continue to generate in the field, and within Truvian has demonstrated the art of the possible in decentralized blood diagnostics," Truvian Health CEO Jay Srinivasan stated. "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.”
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 diagnostic company bringing lab-accurate results to the point of action. With a focus on making routine blood testing accessible, convenient, and transparent, Truvian is accelerating the transition to a sustainable healthcare ecosystem through its benchtop solution that delivers timely, actionable results to help stop disease before it starts.