In a wide-ranging interview, Truvian CEO Jay Srinivasan outlines how the company’s instrument could revolutionize blood testing at the point-of-care: the primary doctor’s office.
By Chris Wolski
Summary: A significant number of Americans neglect routine blood tests due to fear or inconvenience, but Truvian’s new blood testing instrument promises to make testing more accessible and convenient.
Takeaways:
- Accessibility Challenges: Socioeconomic and logistical barriers limit access to routine blood testing for many Americans.
- Innovative Solution: Truvian’s new instrument simplifies blood testing, requiring minimal infrastructure and providing results quickly, which could improve patient adherence to regular testing.
- Potential Impact: By decentralizing and streamlining blood testing, Truvian aims to enhance patient care, reduce undiagnosed conditions, and integrate seamlessly into existing clinical workflows.
While access to routine testing continues to be a challenge for many Americans both in urban and rural settings, a large population that do have access to testing skip their regular, physician-ordered blood tests.
Why? It could be fear of the unknown. Or, in many cases, it’s the inconvenience of heading to a separate lab after seeing a primary care physician. Whatever the case, the result is the same: Many Americans have undiagnosed conditions that could be affecting their overall health and longevity.
However, that could change with a new blood testing instrument being developed by Truvian.
In a wide-ranging interview with CLP, Truvian CEO Jay Srinivasan discusses just how the new instrument will benefit patients, primary care providers, and clinical labs alike.
In addition to his leadership of Truvian, Srinivasan has held executive and management roles at the world’s leading health care companies, including Abbott Laboratories, GenMark Diagnostics, Danaher (Beckman Coulter,) and Qiagen (Digene). He also currently sits on the Industry Advisory Board for the School of Biomedical Engineering at Colorado State University and Drexel University.
Answers have been edited for length and clarity.
CLP: Access to testing is critical to good health—what are some of the factors limiting access?
Jay Srinivasan: Access to testing is limited today due to a variety of socioeconomic, cultural, and other factors.
Social determinants of health (SDOH) determine the level and quality of access to basic health care and testing based on where you live. This is true for most populations not just in the U.S., but more broadly across the globe.
The current workflows tied to the centralized testing model require both scheduling and collection of samples to occur in specific locations such as draw sites, physician office labs, etc., which makes it inconvenient to many as one has to take time away from work, school, or other commitments.
The cost of testing is historically high, making out-of-pocket expense prohibitive to many. And coverage is limited even if one is covered by a private, public, or personal health insurance. Affordability puts testing out of the reach of many across the globe.
It has been harder to serve remote areas across the globe with the testing solutions available today. There is a growing need for solutions like Truvian’s, which need limited infrastructure to operate, provide comprehensive testing, and provide test results that are comparable to a central lab anywhere.
CLP: Your solution is designed specifically as a decentralized, low-use testing modality. How does it work and how does it support laboratory testing?
Srinivasan: The Truvian solution is purpose built to provide comprehensive routine blood testing for anyone, anywhere. The Truvian solution consists of an instrument and a consumable test kit is optimized to require minimal infrastructure to operate.
The Truvian instrument is a first-in-class device that delivers three discrete testing technologies namely, clinical chemistry, hematology and immunoassay in a device that is no larger than a benchtop printer or a desktop computer. The Truvian instrument only needs an electrical power outlet to operate and can leverage existing Wi-Fi for internet connectivity. It does not require additional external reservoirs for reagents and/or waste disposal.
The ability to leverage known technologies that have already been approved by regulatory bodies worldwide provides Truvian with a more robust regulatory pathway to achieving FDA and other approvals. The instrument performs the entire run from sample to final test results without any human intervention after the initial loading of the consumable kit is completed. The instrument leverages onboard Machine Vision and AI algorithms enabled by sophisticated software to produce 34 different test results in under 30 minutes with ~8 drops of blood (300ul) from a single tube.
The Truvian solution uses a single consumable test kit, which consists of a disc and a support pack for each patient sample that is tested on the platform. The disc consists of several processing wells which are preloaded with off-the-shelf reagents to ensure the consumable kit can be transported and then stored under room temperature. The off-the-shelf industry standard reagents purchased by Truvian from reputed third parties are reformulated based on proprietary Truvian methods to ensure these chemistries will be stable when dried down using a custom-developed Truvian manufacturing method.
The support pack includes the hematology feature, liquid handling tips, room temperature buffers, and processing wells. The Truvian consumable test kit is factory calibrated per lot to ensure that the user does not need to individually calibrate each test. In a process we call “pack in/pack out” the consumable kit serves a dual purpose. During the start of a patient sample run, the consumable test kit contains fresh reagent for processing the patient sample, and upon completion of the patient sample run, the same consumable test kit is ejected as the waste container for disposal as bio-hazardous waste.
A Truvian solution onsite will be accompanied by a change in the current clinical workflow to allow a patient to have their blood drawn upon check-in for the annual visit with the results available by the time the doctor and patient are together for the annual exam.
This could radically change current clinical workflows enabling doctors and other health care providers to provide timely results during a patient visit. Ready access to diagnostic test results enables doctors to sit down with their patients and address medical issues collaboratively. Patients are empowered with the knowledge to make necessary adjustments to their lifestyle to address a future chronic condition.
CLP: I hate to bring this up—but what you’re doing sounds a bit like what Theranos was attempting. How is what you’re doing different?
Srinivasan: Theranos had a broad vision to deliver a different blood testing experience than the status quo. For a multitude of reasons that have been documented that vision didn’t materialize. However, the need for access to convenient, affordable, timely blood results is resonant more than ever with the increase in the non-communicable disease burden across the globe.
At Truvian, we have built a first-in-class platform that is intended to solve this need and here is how we continue to do it different from Theranos and others:
- We firmly believe that there is only one way to build a regulated product, and that is “to do it the right way” e.g., build, engage with regulators, and promote the right way. We have established the right governance structure and processes within our organization in line with the requirements of ISO and the FDA to build a compliant product that meets the needs of the regulatory frameworks across the globe.
- We have been data first and transparent in our approach to how we conduct business. Data on our platform has been publicly shared in multiple forums and is also available online on our website for all to see and critique.
- We have actively engaged with the FDA through the pre-submission process that they support for device manufacturers such as Truvian. To date, we have filed eight pre-sub applications with the FDA and engaged actively with them in dialogue as we build our product and regulatory framework prior to our FDA submission. We have also conducted an onsite demo of the platform to help showcase the capabilities of the platform and how it may benefit patient access to timely, accurate blood results.
- We have built an esteemed advisory board since the early days of the company that reviews and counsels the company on scientific and clinical matters to ensure that the data shared is robust.
- Truvian has generated 50,000+ results across 5,000+ donors in 12+ clinical studies that have been documented and shared publicly. We continue to be transparent around the system and its performance in public settings, be it via our showcase of technology on the floor of HLTH ’23 in Las Vegas or the recent independent study performed by UCSD that was shared at ADLM ’24 in Chicago. Our platform has been able to consistently showcase our ability to generate central lab quality results under 30 minutes with ~8 drops of blood (300ul) from a single tube.
CLP: Up-front costs are usually the primary factor that small businesses—such as a primary doctor’s practice—use when determining if a piece of equipment is worth purchasing. If I understand it correctly you’ve tackled both the up-front costs and the ongoing expense of running the solution. Can you discuss the pricing plan for your solution?
Srinivasan: Truvian will leverage a business model which is similar to the razor/razor blade model. This classic diagnostic industry model called the “reagent rental model” will require customers to commit to a specific volume of reagents for a two- to five-year period during which Truvian will provide the instruments for a minimal lease fee that covers service and maintenance of the units during that period.
This reduces the friction for doctor practices to quickly onboard the Truvian solution and generate revenue and profit as opposed to today’s situation where these practices typically do not either offer comprehensive blood testing onsite or make money. Our early pricing studies and internal cost of manufacturing suggest that Truvian customers will generate more than $1 million of annual revenue and more than $500,000 of annual profit in a private practice with about fourto five doctors.
CLP: With a quick TAT and low-cost involved with the testing, it seems that you are kind of circumventing the traditional laboratory. How do clinical labs fit into the diagnostic continuum?
Srinivasan: Your blood tells a story as it is describing your health at a specific point in time allowing you as a patient to take timely care. The goal of the Truvian solution is to make routine blood testing simple, convenient, and accessible for anyone, anywhere. In effect, remove the friction that exists in the centralized blood testing model today that has resulted in more than 40% of the U.S. population failing to adhere to their doctor ordered tests.
The lack of adherence to preventative care is a key reason why more than 50% of the adults in the U.S. have a chronic condition that they are not aware of. The Truvian solution can make it possible where “the lab of the future is not a lab” for routine blood testing. While the Truvian solution intends to address routine blood tests, today’s clinical laboratories will still be required in the future for other testing methods like microbiology, anatomical pathology, mass spectrometry, sequencing, etc. There is a future where the Truvian solution will co-exist with the clinical labs of today be it based on the menu, volume, and/or specialized nature of testing required.
CLP: It was just announced that Truvian will be submitting your solution for FDA approval at the end of 2024. Do you have an expected timeline when it will be coming to market?
Srinivasan: We have shared that Truvian will be initiating clinical trials late summer/early fall with the goal to submit to the FDA by end of 2024/early 2025. We expect to commercialize the solution in 2025 subject to in-country approvals.
Chris Wolski is chief editor of CLP.
Featured Image: Truvian’s blood testing instrument is designed to take routine diagnostic testing to the point of care. Photo: Truvian
