DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accurate results in just minutes.
That would describe the testing analyzer under development at San Diego-based Truvian Sciences. Just last month, the company raised $105 million in a series C funding. Truvian said the money will be used to apply for 510(k) clearance and a CLIA waiver from the federal Food and Drug Administration and it hopes to make that regulatory submission before the end of the year.
Disrupt Core Lab Model
The company’s founders state their objective is to disrupt the existing model of the central clinical laboratory by delivering a self-contained instrument system that is:
- small enough for point-of-care and near-patient settings,
- performs CLIA-waived tests so anyone can operate it,
- produces tests results in just minutes,
- has a competitive cost per test, and,
- is consumer-friendly, because only small quantities of blood are required to run the tests.
As a start-up IVD company, Truvian has ambitious goals. In statements provided to The Dark Report, Dena Marrinucci, founder and Senior Vice President of Corporate Development and Business Operations, said, “Truvian’s automated benchtop system combines clinical chemistry, immunoassays, and hematology assays in one device. The first panel will offer 40 of the most commonly ordered diagnostic tests—including a lipid panel, metabolic panel, and complete blood cell count—to be completed in a single run, from just five drops of blood, and with results in 20 minutes.
Broader Test Access
“Currently, such a panel needs multiple vials of blood and results can take days,” she continued. “And at a fraction of the cost of traditional lab tests, Truvian’s solution won’t be cost prohibitive, thus allowing broader access to more individuals.”
During the past three decades, many start-up IVD companies have pursued the goal of a low-cost, accurate, fast point-of-care (POC) multi-analyte analyzer capable of running most of the routine tests ordered daily in doctors’ offices. But no front runner has emerged in that race.
Truvian predicts it can succeed, arguing there are two new sources of demand for near-patient and POC testing. The first source are consumers. The second source are the national pharmacy companies such as CVS and Walgreens, and the national retailers, including Walmart and Target, that are now establishing primary care clinics in their retail stores.
Clinical lab administrators and pathologists should step back for a moment and consider what is different in healthcare in the United States today, versus, say, 15 years ago. In 2006, the first “convenience clinics” began to appear in retail chains, usually next to the pharmacy. Typically, for a modest fee a registered nurse or nurse practitioner was available to diagnose about 40 to 50 simple conditions, many of which needed a prescription that could be filled by the patient before leaving the store.
2,000 In-Store Medical Clinics
Now, a decade and a half later, there are approximately 2,000 in-store clinics. CVS operates almost 1,000 such clinics. Significantly, most retail chains have plans to expand these convenience clinics into full-service primary care clinics. For example, Walmart already has 20 stand-alone primary care centers and plans to increase that number to 4,000 by 2029.
The executives at these national chains recognize that their primary care clinics will be more productive, and can handle more patients and generate more revenue, if clinical laboratory test results can be produced within minutes of a patient’s arrival at the clinic. Truvian Sciences recognizes that these retail chains are new buyers of speedy diagnostic tests. Moreover, these retail chains will want to purchase millions of near-patient and POC tests each year.
New Demand for Testing
This demand for near-patient testing did not exist until a few years ago. Thus, the trend of more consumer interest in their healthcare, combined with the trend of national retailers wanting to deliver primary care medical services, is what drives a new and substantial demand for clinical laboratory tests that are accurate, fast, cheap, and can be performed where patients see physicians.
Truvian CEO Jeff Hawkins described these twin trends in a MedCity interview. “The idea that has always been at the center of our vision is that our healthcare industry needs to evolve, and as part of that, blood testing needs innovation,” he noted. “Routine testing needs to move closer to the consumer, away from the lengthy process and cost-constricting centralized lab model.
“Consumers need a more convenient solution for health and wellness management that provides them with insights into their own health, at their fingertips, affordably, and rapidly,” explained Hawkins. “Point-of-care solutions with retailers such as CVS and Walmart, are becoming a driving force in bringing routine healthcare to the masses and enabling easier access in a variety of ways.
“But [clinical laboratory] testing continues to be a bottleneck,” he emphasized. “Truvian is driven to disrupt the centralized lab model, making routine health testing convenient, affordable, and actionable for today’s connected consumers.”
Overnight Specimen Delivery
The two Truvian executives are direct and clear about their plans to be disruptive and why the current model of clinical laboratory testing—dominated by the overnight delivery of specimens to central labs, with results reported the next day or later—will cease to meet the needs of both consumers and operators of clinics in retail stories.
“As healthcare continues moving to meet people where they are, Truvian will focus on both retailers and corporate on-site and near-site clinics to enable more convenient testing for today’s connected consumers,” stated Hawkins in the MedCity interview. “We also know that primary care physicians value the rapid insights our platform will deliver to help take some of the guesswork out of their initial diagnosis.”
“With consumers demanding control of their life at their fingertips, health data shouldn’t be any different,” added Marrinucci in the same interview.
“Truvian will also provide results directly to the consumer via an easy-to-use mobile app. This will provide timely access to test results that might otherwise be challenging to get and allow for trend tracking over time.”
Truvian Sciences was founded in 2015. It has raised a total of $150 million in capital, including last month’s offering. Truvian’s diagnostic device resembles a desktop computer. It uses optical sensing systems to deliver clinical chemistries, immunoassays, and hematology all in one instrument. As part of its platform, Truvian can deliver blood test results to mobile phones.Its initial panel would target standard wellness markers such as cholesterol and glucose levels, complete blood cell count (CBC), as well as thyroid, kidney, and liver functions.
Platform and Consumables
“We have innovated in many different ways in terms of the platform and our consumables, and we have captured this in 12 pending patents in the U.S. and internationally across consumables, optical systems, and novel methods of processing blood samples,” Marinnucci told TDR.
She said the company also has a “trade secret technology and manufacturing method” to make storage of reagents at room temperature possible. “And we have implemented a wide range of algorithms for data analysis, including deep learning models for cell counting and differentiation,” Marinnucci said.
“While we have not made the pricing for our instruments and assays public yet, we think that, at scale, these types of routine tests should be available for about one dollar per analyte. At this price, we believe testing can be conducted in many more settings, making access to routine blood testing information more widely available to consumers and their clinicians,” Marinnucci added.
Truvian plans to publish data on its technology in at least one medical journal this year, the San Diego Union Tribune reported. Also, in 2020, Truvian received FDA Emergency Use Authorization for the Easy Check COVID-19 IgM/lgGTM test. Easy Check is a SARS-CoV-2 antibody test with sensitivity of 98.4% and specificity of 98.9%, Truvian said in a separate news release.
There Are Competitors
Truvian may face some competition— at least for CBC testing—from another young diagnostics company: Sight Diagnostics, based in Tel Aviv, Israel, with a newly opened New York office.
In January, The Dark Report published a newsmaker interview with the CEO of SightDx, describing its five-part OLO CBC analyzer. About the size of a toaster oven, OLO has FDA clearance for moderately complex testing in CLIA-compliant facilities. SightDx, founded in 2011, has raised about $124 million in venture capital funds from international and U.S. corporations. (See TDR Newsmaker Interview: “Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance,” Jan. 19, 2021.)
Useful in Clinical Settings
Lab administrators and pathologists working in hospital and health system labs will recognize that the functions and features of the analyzer Truvian is developing could be useful in emergency departments and in the physicians’ offices that are owned and operated by the parent hospital and health system.
Thus, as the Truvian instrument system eventually reaches the clinical laboratory market, on one hand it could be a threat to the central/core lab model. On the other hand, it could be an opportunity for a core lab to develop a clinically-valuable distributed lab testing network that serves all care settings within an integrated healthcare system.
San Diego-based Truvian Sciences Wants to Deliver a Lab Test Solution to Pharmacies, Retail Stores
SOON TO ENTER THE MARKET FOR NEAR-PATIENT AND POINT-OF-CARE TESTING is Truvian Sciences, based in San Diego. Founded in 2015, the company is developing a multiplex desk-top analyzer (shown below).
Truvian believes that there will be robust demand from non-traditional buyers of clinical laboratory tests. This demand will come from national pharmacy chains and retailers with primary care clinics in their stores.
Truvian believes they will want a clinical lab testing solution that requires a small quantity of blood, can return results in minutes, is cost-effective compared to core lab test results, and allows patients and doctors to have the test results needed to make decisions during a single patient visit.
Truvian’s multiplex system is designed to perform 40 most-commonly ordered diagnostic tests
ON ITS WEBSITE, TRUVIAN SCIENCES SHOWS THE PHOTO BELOW of how samples are loaded into its analyzer. In news reports, the company says it will launch with a panel that offers 40 of the most commonly ordered diagnostic tests that can be performed on a single run with just five drops of blood and deliver results within 20 minutes. The first tests will include a metabolic panel, a complete blood cell count (CBC), and a lipid panel.