Summary: Researchers validated the accuracy and reliability of Truvian Health’s multi-modal blood testing platform compared to FDA-cleared devices used in central laboratories.
Takeaways:
- High Accuracy and Reliability: Truvian’s blood testing platform demonstrated performance highly comparable to centralized lab testing, with a 98% run reliability and ease of use confirmed by 100% of operators.
- Decentralized Diagnostics: The platform’s ability to provide comprehensive blood testing at the point-of-care addresses the delays and costs associated with centralized lab testing, making it suitable for use in physician offices, clinics, pharmacies, and long-term care facilities.
- Broad Clinical Validation: The study evaluated samples from patients with chronic illnesses, showing robust concordance with central lab results, reinforcing the platform’s potential to revolutionize routine blood testing and improve healthcare accessibility.
Researchers from University of California San Diego School of Medicine are providing the latest evidence from a recent evaluation of Truvian Health’s (Truvian’s) multi-modal blood testing platform at the Association for Diagnostics and Laboratory Medicine (ADLM) meeting.
Their findings support a growing body of evidence that suggests the future of routine blood testing will be defined by automated, benchtop systems that provide decentralized diagnostics anywhere you go. The independent study (titled “Advancing Point-of-Care Testing: Independent Evaluation of the Truvian Platform”) focused on comparing the performance of Truvian’s blood testing device to FDA-cleared devices found in central laboratories. Findings show the accuracy of Truvian’s device is highly comparable to centralized testing and demonstrates a high degree of reliability.
Improving Routine Blood Testing
Currently, routine blood testing is performed by skilled technicians in centralized labs which delays turnaround times, increases costs, and remains burdensome for patients and providers alike, leading to poor adherence and potential delayed medical intervention. Truvian’s platform has the ability to address these shortcomings by providing patients and providers with comprehensive blood testing at the point-of-care. Following its clearance by the FDA, the device can be placed in physician offices, clinics, pharmacies, and long-term care facilities where samples can be run by non-laboratorians.
“With each Truvian milestone, healthcare providers and patients move closer to a world where they can make informed decisions about their health,” says Dena Marrinucci, PhD, co-founder and chief operating officer of Truvian. “The positive findings from this independent study reinforce our confidence that the accuracy and consistency of our platform can make it possible to access central laboratory quality results anywhere you go.”
Evaluating Patient Samples with Truvian Platform
Samples from patients with a wide range of chronic illnesses were evaluated on the Truvian platform. The results produced from untrained operators using the Truvian platform were concordant with testing performed in the central laboratories by qualified medical staff. Truvian’s platform demonstrated a run reliability of 98% and its user interface was described by 100% of operators as “easy to follow.”
“The data from our independent evaluation showed the platform’s robust concordance to comparator devices, indicating its performance, usability and suitability in various clinical settings,” says Susan Little, MD, director of the AntiViral Research Center (AVRC) at UC San Diego School of Medicine and principal investigator of the study.
Expansion of Truvian
To continue its efforts in redefining the future of blood diagnostics, Truvian recently expanded its Clinical Advisory Board with the additions of Karim Vellani, MD, CCFP, chief medical officer of Shoppers Drug Mart in Canada, and Jennifer Peña, MD, FACP, AAHIVS, who served as a physician in the White House Medical Unit over two administrations and is both the founder and owner of Medicina Exclusiva, Puerto Rico’s top executive and concierge medicine consulting firm. Truvian’s Clinical Advisory Board is comprised of renowned clinicians with deep experience in patient-provider relationships who will help enable transparent, evidence-based adoption of blood testing across the globe.
“The results of a pilot through Shoppers Drug Mart were similar to that of the UC San Diego study – that Truvian’s comprehensive blood testing solution has the ability to make blood testing more convenient and accessible to patients,” says Vellani. “I’m honored to join Truvian’s Clinical Advisory Board and look forward to working with the team leading innovation in blood testing.”
“This independent study provides strong external validation of the fact that Truvian’s multi-modal platform can achieve clinical performance equivalent to the central laboratory across a large panel of tests with a single sample,” added Peña. “The ability to improve quality of care and patient outcomes for people around the world is critical, especially in locations like my homeland of Puerto Rico that faces many challenges to its healthcare system. Collaborating with Dr. Vellani, the Clinical Advisory Board, and the Truvian team to fulfill their mission aligns with my personal and professional purpose.”
Photo: Truvian
