Truvian Health is progressing in its mission to disrupt blood testing.
Last month, the San Diego-based diagnostics company presented clinical data showing its benchtop can provide reliable test results across 32 of the most commonly ordered tests.
CEO
Truvian Health
“We validated the fact that for the first time we could demonstrate that a three-modality platform can generate central lab quality results at point of action or point of care,” said Truvian CEO Jay Srinivasan.
Truvian’s benchtop utilizes three commonly used testing technologies – immunoassay clinical chemistry, and hematology – and merges those three kinds of systems into a single instrument “no bigger than a desktop computer,” Srinivasan said. “The real innovation was how to miniaturize all three modules while providing same performance as a clinical reference lab.”
Truvian’s data from a recent multi-site clinical study, which was presented at the 2023 American Association for Clinical Chemistry annual scientific meeting, showed the benchtop could deliver results for multiple tests simultaneously across a large panel of assays from a single blood tube.
“We need no more than about eight drops of blood, about 300 microliters of blood and we are able to generate central lab-level quality,” Srinivasan said.
Among the assays highlighted by the study, Truvian’s technology can detect low abundance targets like thyroid stimulating hormone (TSH) with same sensitivity as third generation TSH assays, the most sensitive screening tool for primary hypothyroidism.
The company also presented results from a reproducibility study to evaluate performance of multiple machines over multiple days. Truvian’s platform achieved acceptance criteria for 99% of 25 assays evaluated.
Path to Commercialization
Now that Truvian has validated its benchtop’s abilities, Srinivasan said the next step is to test the instrument in the field and validate the results in preparation for FDA clinical trials.
“All these studies leading up to that are meant to mature the product and also prove that the product performs,” he said, adding that the results must show reliability from “a human factor perspective.”
Truvian plans to make the benchtop CLIA waived so that “anyone could run it with limited training,” Srinivasan said, because the system will eventually be used in various environments, such as retail clinics like Walgreens and CVS, corporate clinics like One Medical and Forward, as well as integrated health networks.
After further testing to verify the benchtop’s design to known requirements, Truvian is aiming to start the FDA clinical trial process sometime in the second or third quarter of next year.
A Market Need
To get there, Truvian plans to raise more capital.
“We will raise a Series D in the near future that will really support the second half of clinical trials through launch,” Srinivasan said, adding that the company is seeking strategic investors “to be a part of our product journey through the commercialization phase.”
Attracting investors has not been an issue for the company. In 2021, Truvian raised $109 million in an oversubscribed Series C and has raised a total of $150 million to date.
Srinivasan said investors are still very interested in blood testing solutions, despite the very public collapse of Elizabeth Holmes-founded Theranos, which promised a similar solution to blood testing.
He credits Truvian’s success in raising capital to its robust data and the market’s need to modernize today’s “friction-laden” blood testing that requires several blood draws sent to different labs and then a wait for results.
“All that infrastructure that goes from point of draw until when results are available has been our focus and our design consideration,” he said. “What Truvian is doing is really short-circuiting all that. We’re taking away the time; we’re taking away the number of tubes of blood; we’re taking away the potential compromised nature of these tubes of blood as they travel.”
The blood testing in the U.S. is an $85 billion a year market which is expected to grow to $140 billion by the end of the decade, Srinivasan said, adding that Truvian’s initial focus will be on routine blood tests currently performed at central laboratories.
Truvian’s platform can run the most ordered tests that account for more than 80% of blood test orders. The automated benchtop also uses pre-packaged single use test kits with reagents that have already been proven by the FDA and are stabilized to be used without needing a cold chain at customer locations.
“Our product in late-stage development targets $20 billion of the addressable market, though we aim to capture an even more significant part of the routine testing business over time via product capability expansion, such as adding more tests to our menu,” he said. “We believe our solution will substantially change how healthcare is dispensed. Our goal to provide and accessible healthcare to all and drive down cost of care and blood testing over time.”
Truvian Health
Founded: 2015 (as Truvian Sciences)
Headquarters: San Diego
CEO: Jay Srinivasan
Business: Diagnostic benchtop machines for blood testing
Funding: $150 million (Series A-C)
Employees: 100
Website: truvianhealth.com
Notable: 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.
