Truvian CEO Confident Blood-Testing Benchtop Could Be ‘Any Place You Go’

After raising $74m in a private financing round and presenting positive clinical data results this summer, Truvian Health Inc. is making huge strides toward succeeding where Elizabeth Holmes’ Theranos Inc. famously failed.

The San Diego-based diagnostics company is using the new funding injection to advance clinical trials and submit its blood-testing platform for 510(k) clearance from the US Food and Drug Administration by the end of this year or early 2025.

“The most important thing I feel about our product is that in meters and minutes from draw, we’re able to give you your blood results,” said CEO Jay Srinivasan, who, along with Truvian co-founder and chief operating officer Dena Marrinucci, guided Medtech Insight on a tour of the company’s 30,000-square-foot-headquarters, which houses R&D, manufacturing of consumables, and operations.

“The effective nature of being able to do that [testing] reliably, consistently and anywhere allows our product to be placed anywhere,” he added.

In the US alone, about 50% of adults skip routine blood testing due largely to its inconvenience and friction points in the process, which typically means having to make an additional appointment to visit a laboratory and often waiting days for results. Truvian’s mission is to streamline the process by offering patients blood testing results in less than 30 minutes at point of care.

“Instead of having to draw that blood and send it out and go through all the steps that need to happen, now it can be done on site, and those timely results really allow the health care provider and the patient to talk about those results,” Marrinucci said. “The increase in chronic disease in the US and worldwide is going at a pace that’s not sustainable, and we need to action on that. This is a great solution to get these insights much, much earlier.”

What makes Truvian’s benchtop unique is that it’s “three in a box … no one has done this before,” according to Srinivasan.

Had the great opportunity today to visit with Truvian at their headquarters. Did a blood panel with results in 30 minutes. Thanks to Dena Marrinucci and Jay Srinivasan for the interview. Look for upcoming story in Citeline’s #Medtech Insight. #bloodtesting #diagnostics pic.twitter.com/3yPAqGikM3

— Marion Webb (@medtechMarion) August 20, 2024

The benchtop, about the size of a desktop computer, combines three testing technologies – hematology, immunoassay and clinical chemistry – in a single instrument to perform 34 ordered tests using a single blood tube. The tests cover more than 90% of the most commonly ordered blood tests, including lipid panel, comprehensive metabolic panel (CMP), and thyroid, liver and kidney function. And “we only need 300 microliters of blood to run the full suite of tests,” Marrinucci noted.

Given Theranos’ highly publicized implosion, which resulted in founder Holmes being convicted of fraud, Truvian takes pains to be fully transparent about its technology, including showcasing the evolution of its benchtop platform.

Presenting the company’s current prototype, Marrinucci pointed to a pair of closed cabinet doors beneath the instrument and noted, “We had some investors sort of looking under there. That’s why we developed this demonstration, so you can actually see how it works.”

It took years after Truvian was founded in 2015 to optimize the reagents, hardware, software, the panel, algorithms, and so forth, she explained. The company has “miniaturized every aspect of how to produce a result” – including the compact disc-like cartridges that incorporate multiple processing wells, to facilitate every aspect of testing, such as sample preparation, reagent mixing and measurement. The proprietary technology includes leveraging off-the-shelf chemistries that are preserved in a dried-down way and are stable at ambient temperature, which is attractive for clients such as doctors’ offices, pharmacies, retail clinics and corporate clinics like One Medical and Forward as it doesn’t require special refrigeration.

The benchtop platform is designed to be used by anyone, with no lab experience or scientific background required, Marrinucci said. The results are displayed on-screen and can also be printed. Upon launch, the instrument will have the capability to transmit results directly to a patient’s electronic medical records and make them available on a mobile app, she said.

Truvian’s latest funding round, announced last month, was co-led by Wittington Ventures and Great Point Ventures with continuing backing from existing investors including 7wireVentures, DNS Capital, Medical Excellence Capital, Tao Capital and TYH Capital. (Also see "Truvian Health Raises $74M In Funding For Automated Benchtop Blood Testing Analyzer, Pursues FDA Clearance" - Medtech Insight, 18 Jul, 2024.)

It brought Truvian’s total funding raised to date to over $200m.

Clinical Trials, Regulatory Pathway

Over the last 12 months, Truvian has presented data from multiple independent clinical studies showing the results from its blood testing are equivalent to those produced in a central laboratory across a large panel of tests. 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 (ADLM) annual meeting, researchers at the UC San Diego School of Medicine presented results from a study evaluating the accuracy, reliability and usability of Truvian’s platform in a point-of-care setting, using 105 samples from donors who were apparently healthy as well as individuals with chronic diseases. Truvian’s accuracy was found to be “highly comparable to centralized testing and the instrument is reliable and easy to use,” the researchers said.

Data from a multi-site clinical study, presented at the 2023 (ADLM) annual scientific meeting, also showed Truvian’s platform could deliver central laboratory-quality results simultaneously across a large panel of assays.

For example, Truvian’s system was able to detect low abundance targets like thyroid stimulating hormone (TSH) with the same sensitivity as third-generation TSH assays.

“Thyroid [stimulating hormone] is very sensitive and was a way for us to pressure-test our product and its capabilities,” Srinivasan said.

Source: Truvian

Marrinucci envisions that in the future the company will add more tests, noting that Truvian's Wellness Panel today uses only about 30% of the wells. “You could have a cardiac disc, or a fertility disc or a women’s health disc, or you can use the same disc, but you use different reagents in the slot for those different types of tests,” she explained.

Truvian plans to file for FDA (510K) clearance using data from a prospective clinical trial that will compare results from its instrument against those of the market-leading system for clinical chemistry and immunoassay, Roche’s Cobas, and the leader among clinical hematology analyzers, Sysmex Corporation’s Sysmex XN.

That will be followed by a Clinical Laboratory Improvement Amendments (CLIA) application to allow its systems to be used in a retail setting or doctor’s office.

To support those aims, Truvian is currently setting up four sites for trials that it expects will enroll about 600 people total, both healthy individuals as well as chronic disease patients, and last about three to four months, depending on Truvian’s ability to recruit patients with multiple chronic diseases.

“Because our panel is 34 tests, you have to get different disease states to make sure you cover the range for every single test [required by the FDA for data submission],” Marrinucci explained.

The first study will be a precision study to assess whether Truvian’s platform can deliver consistent and reliable results, and the second will be the method-comparison study to measure Truvian’s performance against established instruments.

The company had the opportunity to meet with FDA officials in June for a live product demo, which went well, Srinivasan said. In another month, it will meet with the FDA again to review final trial protocol and meet with the four branches that will be involved in the review process – diabetes, hematology, immunology and chemistry. He noted that Truvian engaged with the FDA very early on and has been working with a lead reviewer for years. “Now it’s all about the data,” he said.

Marketing Strategy

Part of Truvian’s new funding will be used for early commercialization of the benchtop instrument with a main focus on the US market. Further down the line, Truvian could pursue long-term care facilities, such as nursing homes, and chronic care centers, such as cancer centers and dialysis centers, among other potential customers.

“I always say we could put ourselves in any place you go,” he said. “So technically this could sit in the school or a university … this could sit in a stadium like at the Bears facility or the Padres facility, and now we’re able to do testing right there.”

Truvian’s business model will be of the razor and blade variety where it charges a rental fee for the instrument whose data goes to Truvian’s private cloud; customers then buy a certain volume of tests. Today, the consumable costs less than $10 to manufacture, which Srinivasan expects will decline.

The company plans to enter new geographies through different types of partnerships, he said. “Our goal is to have almost like the Intel Inside or Oracle partnership model, where we partner at a retail level, at an executive level and enterprise level and be able to make it standard of care,” he explained.

In Canada, Truvian has already entered a partnership with Canada’s largest pharmacy, Shoppers Drug Mart, to evaluate its technology, and plans to submit for regulatory approval at Health Canada.“We would roll it out with the Shoppers team in the specific provinces that they pick first and then eventually across Canada,” Srinivasan said.

The CEO estimates that the US addressable market for Truvian’s product is about $20bn, the Canadian market being about one-sixth of the US market, or roughly $3.3bn, with both markets seeing an upward trend for non-communicable diseases. The company will also explore entering other markets such as Mexico and other countries in Latin America, the UK, and countries in Northern Europe.

Srinivasan said Truvian deliberately held back in filing under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) because of the evolving landscape.

“We don’t want to jump on IVDR, because there are other markets we can get to early and build enough proof of points,” he said, adding, “We didn’t want to jump in [that] market until the noise has settled around legislation there.”

If Truvian secures FDA clearance, it would be the first to introduce a platform that has three analyzers merged into one. But there are other start-ups also exploring what’s possible in the blood testing market.

Genalyte Inc., located just a few miles away from Truvian’s headquarters in San Diego, announced on 22 July it received the first FDA clearance for a thyroid stimulating hormone immunoassay performed on a silicon chip, a “significant milestone.” The company’s Maverick device, the size of a small microwave, uses silicon-chip-based technology to perform rapid tests on a small blood sample with results in about 30 minutes. It also has attracted high-profile backers including Alphabet company Verily, which led a $50m funding round in 2021.

Austin-based health care company Babson Diagnostics announced the launch of its blood testing system BetterWay at select locations including H-E-B Pharmacy, Peoples Rx and Lake Hills Pharmacy in Austin starting this July. It uses a fingerstick collection device to obtain blood samples to support annual wellness exams, chronic condition management and screenings.

Srinivasan is confident that Truvian’s model will offer clients advantages over competing systems.

“What we’re solving for is space, footprint, logistics, ease-of-use, single kit, single tube – we’re solving for a lot of things.”