NEW YORK – After raising $74 million in a private financing round last month, point-of-care testing firm Truvian Health is using the funding to further its clinical trials and submit its automated benchtop analyzer for clearance from the US Food and Drug Administration by the end of 2024 or early 2025.
The analyzer is about the size of a desktop computer and is able to perform hematology, immunoassay, and clinical chemistry testing from a single blood sample. According to CEO Jay Srinivasan, Truvian sees it being used in clinics, doctors' offices, and pharmacies.
The firm leverages traditional testing technologies — with some proprietary modifications — but has "miniaturized every aspect of how you produce a result" from blood testing, including the consumable, reagent volumes, and sample volume required to run assays on its analyzer, Srinivasan said. It requires about 300 microliters of blood to perform its tests, which are discs preloaded with stabilized off-the-shelf reagents that do not require refrigeration.
Truvian plans to commercially launch its analyzer with its Truvian Wellness Panel, which includes a variety of routine tests typically performed at a doctors' office or clinic visit, such as complete blood count differential, lipid panel, chemistry panel, and HbA1c. The test results, Srinivasan said, are meant to serve as a baseline indicator for a patient's health.
The single-use consumable contains multiple processing wells with different reagents for the different tests it will run, allowing them all to be processed with one consumable and a set of reagents already included. The proprietary technology that Truvian has developed and is patenting includes the chemistry it can add to existing tests to make them shelf-stable, allowing Truvian to reformat many existing tests onto its disc consumable and use them with its analyzer, Srinivasan said.
The analyzer runs one sample at a time and returns results in less than 30 minutes, which Srinivasan noted makes it a good fit for the company's initial retail targets of doctors' offices, clinics, and pharmacies, although he added that other care settings like veterinary medicine offices may be attractive in the future as the company develops more tests. Those locations were chosen because there "is existing infrastructure there that already could support a level of testing," he said.
The firm plans to use a reagent rental model, allowing customers to purchase a certain volume of tests and have an annual lease for the instrument. At scale, the consumable costs less than $10 to manufacture, and the company has plans to decrease that production price, Srinivasan said. However, he declined to share how much the consumable will cost for a customer.
The time to result also can be reduced to below 30 minutes depending on the tests being run, Srinivasan noted. For a panel that doesn't include a high-sensitivity test like thyroid stimulating hormone, results could be returned in 15 minutes or less. The time to result is "dependent on what gets put on the disc," he said. Truvian has multiple waves of test launches planned, but for now is focused on the launch of its analyzer with the Truvian Wellness Panel. The company doesn't plan to launch individual assays, and instead will stick to larger panels, although some of the assays included on one panel may be reused on another panel, Srinivasan said.
Last month's $74 million raise follows a $105 million Series C financing round that Truvian said at the time would go toward getting FDA clearance for its testing platform and to commercialize an automated benchtop platform.
While the firm's main priority is entering the North American market and specifically remains gaining FDA 510(k) approval, Truvian is identifying what it will need to do to attain regulatory approval outside of the US, in places like the UK, EU, Southeast Asia, and the Middle East and Africa.
Similarly, it is exploring which distribution channel would be best for the company depending on geography. In some parts of the world, such as in Israel, distribution partnerships will likely be an easier and faster pathway to commercialization, but in others, such as in Singapore, directly distributing its products may be a more efficient strategy.
Because the instrument only requires a power cord, access to Wi-Fi, and the consumable, it may also be appropriate for use in low-resource settings that do not have centralized laboratory infrastructure, Srinivasan said. It is a "lab without a lab" that "can exist anywhere."
Theranos comparison
Srinivasan is well aware of potential comparisons of Truvian to the infamous Theranos, which offered a similar promise of quick, point-of-care, lab-quality testing with small amounts of blood and raised millions on a false promise. He noted that Theranos was based on a vision and a need that still exists, but that Truvian has data to support its vision and has focused on making its technology robust. "We built the evidence that indicates the technology works," he said.
In total, the firm has tested more than 50,000 samples from more than 5,000 patients.
Last month at the Association for Diagnostics and Laboratory Medicine's annual meeting, researchers at the University of California, San Diego presented results from a study of the instrument that found that results from the platform were concordant with results from central laboratory tests, such as those run on the Roche Cobas and Sysmex XN instruments. The study looked at 105 sample donors, including both healthy patients and those with chronic diseases, and found that the test results from the Truvian Wellness Panel, such as for glucose, cholesterol, hemoglobin, and calcium levels, were overall concordant with the comparator assays.
In addition, the study looked at ease of use of the platform for untrained operators. Of the 11 untrained operators who used the platform, all found the system interface and prompts easy to follow. Ninety percent found the system intuitive and straightforward to use, and 90 percent felt it will be easy for most people to learn.
Susan Little, a professor of medicine at UCSD and the lead investigator on the study, said that the one missing capability in Truvian's current platform is the ability to link results to a patient's medical record, which would be necessary "to make this practical in a high-throughput provider's office."
Srinivasan noted via email that test results are exported to Truvian's secure cloud, which can then integrate with any electronic medical record leveraging third-party integration tools. He added that pilot studies toward the end of this year will include EMR integration to demonstrate the workflow, and as part of commercialization, each customer EMR will be integrated prior to a device going live.
Little also noted that for high-throughput offices, only being able to load one sample at a time is a challenge, and the ability to expand to multiple samples at one time "would be a tremendous advance." Because the device relies on a single-use consumable, there is also a "fair amount of material waste" generated in a large office.
However, she said the fast turnaround time is "huge in terms of keeping patients involved in their own care" and noted that it could fit into traditional doctors' visits where a patient gets blood drawn at the start of the visit and the clinician is able to discuss their lab results by the end of the encounter.
The device "has the potential to be incredibly useful," Little said.