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In September 2015, Dr. Dena Marrinucci set out to perfect a tabletop device that could rapidly test a small amount of blood, returning results for more than 30 routine tests in under 30 minutes. If the concept sounds familiar, that's because it is. She wasn't the only one with ambitions to transform the laboratory industry.
The month after Marrinucci co-founded Truvian, The Wall Street Journal published an exposé accusing Theranos—Truvian's now infamous, defunct competitor—of misrepresenting the accuracy and reliability of its own blood-testing technology, while deceiving doctors, patients and investors. At the time, Theranos was valued at $9 billion and had raised more than $400 million from investors, including Walgreens, Oracle founder Larry Ellison and media mogul Rupert Murdoch.
The Journal's investigation set off a domino effect. The Centers for Medicare & Medicaid Services (CMS) called out compliance issues at Theranos' lab, and the company's high-profile partnerships began to fall through. Theranos lost its license, and last summer, its CEO, Elizabeth Holmes, began an 11-year prison sentence.
When Truvian launched in 2015, Marrinucci had six months of seed money from venture capital firm Domain Associates and plans to raise a larger round quickly. But after the Theranos debacle, Truvian needed more than proof of concept. It needed proof of candor.
"We recruited some of the naysayers of Theranos, very high-profile opinion leaders in the laboratory medicine space," Marrinucci told Newsweek. "We said, let's bring them onto our team and learn from them and understand their skepticism, and have them help us review data from the very onset of the company."
It took two years for Truvian to close its Series A funding round and begin refining its tabletop laboratory device. About six years and eight months later, I was rolling up my sleeve to test it out myself.
My Rapid Blood Test With Truvian
I first met Marrinucci and Jay Srinivasan, Truvian's CEO, on September 6, 2024. They'd set up shop on the upper floor of Chicago's Wrigley Building in a suite belonging to DNS Capital, one of Truvian's investors.
The FDA hadn't (and still hasn't) approved the company's platform, so I had to enroll in a "pilot study" of the "investigational device" before using it.
"Operators will run the Truvian blood analyzer to assess usability," the nine-page waiver explained. Up to 500 blood donor participants could be enrolled in this study, and our information could be shared with a slew of governmental agencies—both in the U.S. and other countries. There was nothing out of the ordinary for a company seeking regulatory approval; I signed off on the tablet and went in for the draw.
Truvian's platform requires very little blood, but the smallest tube on the market is 4 milliliters—so that's how much the phlebotomist drew. It was quick, and afterward, I donned a Band-Aid with the Truvian logo.
In the next room, two Truvian devices sat on a countertop, plugged into the standard wall outlets. The machines don't require an internet connection to operate or produce results. One had been equipped with transparent sides so I could watch the inner mechanisms as it ran. (I asked for photos of this clear machine, but Truvian declined to share publicly.)
One perk of Truvian's device is that anyone can operate it—you don't have to be a trained lab professional—because the device prompts each step and does all its own calculations, Marrinucci explained. That could relieve pressure on clinical laboratories, which are battling staffing shortages amid increased demand for their services. Plus, if the device receives a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA, it could be placed in doctor's offices and operated by existing nurses or medical assistants. Physicians could also receive and discuss routine test results with the patient during the appointment—no off-site shipping required.
Notably, my blood sample only traveled a few meters from the collection point to the device. Srinivasan, Truvian's CEO, pointed out that transportation is one of the most challenging parts of the traditional testing process. Up to 68 percent of laboratory errors occur before the samples are analyzed, according to a recent study in the monthly journal Biochemia Medica.
I scanned the barcode on my blood sample vial to sync the machine with my ID, then clicked through some questions on the device's touch screen: date of birth, sex, fasting status. These details are used to calculate the "normal" ranges for some assays, Marrinucci said.
There was an option to run a single test, but I opted for all 34 tests included on Truvian's flagship "TruWellness" panel. That accounts for a number of routine lab tests, including a comprehensive chemical panel, lipid panel, CBC with differential, hemoglobin A1c and thyroid-stimulating hormone.
Marrinucci inverted my sample tube a few times to mix it, then placed it in a square "support pack" to hold the sample within the machine. A tray slid open on the device, and I placed the support pack inside, along with a disc containing processing wells and the reagents needed to perform the test.
The tray slid back in—similar to a DVD player—and the machine began whirring.
Standard central labs have separate analyzers to run different assays, Marrinucci said. Truvian has confined the major ones to a single device, allowing for simultaneous clinical chemistry, immunoassay and hematology testing. It employs a deep learning algorithm also used in generative AI to examine the blood cells.
Around the 30-minute mark, it was time to view my results. They displayed on the screen, but later, I uploaded my sample ID number to access them on Truvian's app.
I knew what I was looking for—two values that have been slightly elevated on every routine blood test for years, including the panel my primary care doc ordered less than a month earlier. Sure enough, Truvian detected slight elevations on both.
I wasn't the first to approach the device with a "gotcha" in mind, according to Marrinucci. Truvian has run samples at multiple popular health care conferences. Many attendees are pleasantly surprised when the device detects those telltale markers, and word travels fast, Srinivasan said: At the 2023 HLTH conference in Las Vegas, appointments sold out within the first hour.
"The skeptics—which we welcome—they'll come in and they'll get their blood drawn, and when they see their own results, they become believers," Marrinucci said. "Seeing is believing."
Recently, Truvian's "believers" have come to include some high-profile figures in laboratory and diagnostics. Dr. Tina Nova, former president and CEO of the urologic cancer diagnostics company Decipher Biosciences, joined Truvian's board of directors in December. On January 13, Truvian announced the appointment of David King—the former CEO of Labcorp, who steered that company from 2005 to 2019—to its advisory board.
In an exclusive December interview, King told Newsweek that there are a number of near-patient blood testing devices from well-established companies, like Cepheid, Roche and Siemens. But Truvian's stood out to him for its comprehensive capabilities.
"Most [near-patient blood testing devices] are limited in the number of analytes they can test," King said. "That has been one of the obstacles, as the doctor's offices have a limited amount of room. They don't want 20 tabletop instruments so they can do all their testing."
King believes Truvian could help make near-patient testing more effective: "I believe that routine blood testing is going to be increasingly democratized."
Dr. Hakan Sakul, former vice president and head of diagnostics at Pfizer, also backs Truvian as a member of its advisory board. Sakul—who also sits on the advisory council for California Governor Gavin Newsom's Initiative to Advance Precision Medicine—told Newsweek the company's transparency allowed him to build trust. He could visit with the device's developers, look at the machine and analyze his own sample. Posters and publications detailing Truvian's capabilities were publicly available.
"I was really excited that someone was actually able to deliver on that earlier promise that Theranos failed to deliver," Sakul said.
Shaking Theranos' Shadow
Despite Truvian's star-studded backing, Theranos' stain is tough to scrub out. It is difficult to ignore the surface similarities between Truvian and Theranos: the three-syllable name beginning with "T." The crisp white branding, accented in shades of blue. The size and shape of the device, the speed and simplicity it promises.
"[Truvian's] biggest challenge," Sakul said, "was probably to show that what they had was not going to be another failure."
Sakul's point echoed one Marrinucci made in our first meeting, while reflecting on the longer-than-expected funding rounds.
"After Theranos' unraveling started to really snowball," Marrinucci said, "investors were very hesitant to participate in a similar story."
Dr. Alan Wu did play a role in both stories. He is the chief of the clinical chemistry laboratory at San Francisco General Hospital and chief of the clinical pharmacogenomics laboratory at the University of California, San Francisco. Now, he also sits on Truvian's Scientific Advisory Board—and claims it is different than Theranos.
Wu told Newsweek that about a decade ago, Holmes asked him to be Theranos' laboratory director. He declined because he wasn't interested in quitting his day job at San Francisco General. He watched from a distance as Holmes attempted to start a clinical testing service with Walgreens, and said he felt concerned that the technology wasn't ready. Those fears were confirmed as CMS shut down Theranos' labs in 2016.
But then, Holmes pivoted to rebrand Theranos as a technology company and create a "next-generation testing platform," Wu said. She contacted him again in mid-2016, and this time, Wu agreed to join her board.
Why would a reputable laboratory chief climb aboard a sinking ship? "I thought that her technology still had promise, and was hoping that we could turn that into a viable product," he said. Something had to change in the industry: Persistent staffing shortages and heightened demands have led to delayed lab results, which is "just not good medical practice," according to Wu.
Theranos wasn't the right revolutionary, but he believes Truvian could be.
"The concepts that Elizabeth Holmes had earlier were still sound and resonated with me," Wu said. "Her accomplishments and approaches failed, but I was convinced that the Truvian group had the technology and promise.
"Hopefully I could help them in terms of not repeating some of the mistakes that Theranos made," he continued, "and I think that we have been successful in that respect."
The biggest criticism of Theranos was its lack of transparency, according to Wu. The company did not share its studies with scientists or the public.
Theranos also waited too long to engage laboratory thought leaders, Wu said. Holmes launched a scientific advisory board after the lab operation had been shut down. Her unusual board contained more politicians than scientists, including former Secretaries of State George Shultz and Henry Kissinger. Wu asked, "Would you trust your laboratory testing results to them, or would you trust the information to people who do this for a living, like myself?"
In contrast, Truvian has appointed a board full of medical doctors, chemists and laboratory scientists. It shares study results publicly on its website. It has spent an "exorbitant" amount of time preparing to launch and ensuring there are no missteps, Wu said. He believes that caution is necessary—especially as the public expects more information and clarity from their health care providers. With the seemingly limitless internet at their fingertips, people don't accept every doctor recommendation as fact. They want to see for themselves, to fully understand.
"There is some backlash from Theranos that people still remember or might see in the various documentaries and may be a little bit suspicious as to quality," Wu said. "The public's trust has to be regained by quality products and demonstrating that these next-generation tests have value in meeting these medical needs."
There is significant ground to make up—and not just for blood-testing companies. Only 34 percent of Americans said they trusted the medical system in a 2023 Gallup poll. As their faith wanes, private equity firms are increasingly scooping up physician practices, and less than 15 percent of hospital board members are health professionals.
Holmes had a board full of businessmen and dropped out of Stanford University before obtaining her chemical engineering degree. Marrinucci, on the other hand, holds a Ph.D. in chemical biology, founded the successful cancer diagnostics company Epic Sciences and is an inventor on 12 patents.
Health care is highly complex, according to Truvian CEO Srinivasan, who served as a divisional vice president for Abbott, a major laboratory and medical device company, before joining Truvian. In this space, it pays to know the rules—and follow them.
"If you were coming from Silicon Valley, trying to build a product in health care, it may have been nontraditional to accept, to engage with regulatory bodies," Srinivasan said. "But I've grown up in health care, so that's all I know how to do."
Proving Truvian's Accuracy and Reliability
Even with the right experience, it is notoriously difficult to bring new medical devices to market.
Dr. Julie Shaw is the head of the biochemistry division and director of the point-of-care testing program at the Ottawa Hospital in Canada. Speaking generally about point-of-care tests (she was not familiar with Truvian, specifically), Shaw told Newsweek the industry hasn't changed all that much throughout her career.
It takes a long time to develop reliable systems, much less to obtain regulatory approval for them, according to Shaw. But patient and physician demand for these devices is increasing as people look for near-instant results.
More point-of-care tests would be useful to help combat the shortage of laboratory workers, Shaw said. They could also help provide quick care in remote locations, or in long-term care facilities to prevent unnecessary transportation of patients.
When evaluating point-of-care tests, transparent data is vital, Shaw said.
"If no data can be provided to show a comparison, or the vendor will not allow me, as a lab [director], to do my own comparison," Shaw said, "that would be a bit of a red flag."
In order to obtain FDA approval, companies must prove that their device delivers accurate and precise results across a wide range of clinical situations, according to Shaw.
Last year, Truvian conducted a dozen independent studies showing that the device provides equivalent results when stacked against central lab analyzers. One of those studies was an on-site evaluation by Shoppers Drug Mart (Canada's largest retail pharmacy chain), which found concordant results between Truvian and a central laboratory. Shoppers Drug Mart later joined Truvian as a commercial partner.
In July, the University of California, San Diego, presented similar results from its own study. University researchers found that test results from untrained operators using the Truvian platform aligned with test results from trained medical professionals using traditional lab equipment. The platform demonstrated 96 percent run reliability across 50 donor samples and 11 operators—only one error occurred when an operator loaded the blood tube incorrectly. Truvian reports a run reliability rate over 98 percent across the 50,000 samples and 5,000 donors it tested from 2023 to early 2024.
Now, the UC San Diego team is working on a larger, multisite study that will provide data for the FDA application—with hopes to submit in early 2025, according to Dr. Susan Little, the study's principal investigator and director of the AntiViral Research Center at UC San Diego School of Medicine.
When I asked Little for her remaining questions about Truvian's device in late September, she said, "I don't think I have any concerns right now." But if it does come to market, Little suspects everyone will want to know the cost.
Truvian intends to operate a reagent rental model, Srinivasan said. Under these models, laboratory companies provide machines to clients at little to no cost. In turn, clients purchase a set number of reagents (or in Truvian's case, "consumable kits," including the support pack and disc) from the laboratory companies each year. Truvian will make the bulk of its revenue from these kits, which are manufactured at its San Diego location.
At scale, Truvian can produce each kit for less than $10, according to Srinivasan. He expects to keep costs under $70 for patients paying out of pocket. Since the device does all the work, each analysis requires fewer employees than a standard blood test—so insurance companies should also expect lighter bills than they get from standard labs.
Srinivasan envisions a direct integration with electronic health records like Epic and retail health providers like CVS, Walgreens and Walmart. "We want to be in their ecosystem," he said.
King, the former CEO of Labcorp, said he sees two potential outcomes if Truvian's device is approved. It's possible that large practices which already have a phlebotomist on staff will continue to send most of their tests to a large central lab because "it's a one-stop shop," according to King. He doesn't see Truvian putting major laboratories like Labcorp or Quest Diagnostics out of business—but says that isn't the company's aspiration.
King does foresee the device being useful for annual physicals or check-up appointments, such as for patients on thyroid medications or blood thinners that may need lab work ahead of dose adjustments.
"That would be super convenient for the doctor to be able to do that on the spot," King said.
Truvian's Potential in Health Care
Truvian also has potential in less traditional locations, according to Dr. Jennifer Peña, an internal medicine physician who recently joined the company's Clinical Advisory Board.
Peña is a combat veteran and spent 15 years in the U.S. Army. Her last duty stations were in the White House Medical Unit, where she served the Obama and Trump administrations and was the primary physician for Vice President Mike Pence and his family.
Peña first learned of Truvian at a conference and believes it could have "tremendous" impact on physicians' daily lives—especially those in unconventional practices.
"The ability to access labs at the clinical setting with quick turnaround just really spoke to me," Peña said. "In the Department of Defense, obviously those types of technologies would be amazing, to be able to iterate on results right away and deliver care."
She also sees promise in remote locations, like in her homeland, Puerto Rico. Peña moved back to the island in 2022, where she serves as a physician consultant for health tech and telemedicine companies and owns Medicina Exclusiva, an executive and concierge medicine practice.
Some Puerto Ricans live in rural, mountainous areas or off-coast islands without acute care access, according to Peña. This is particularly challenging for patients with chronic health conditions that require frequent lab work. If Truvian's tabletop devices could be placed in isolated communities, it could cut down on travel time—and costs.
"In Puerto Rico, our reimbursement rates are tremendously low compared to the mainland," Peña said. "Having to order five different assays for something that I can do in one [with Truvian] does have significant cost implications for the patient."
For doctors, it could be a "game changer" to rapidly diagnose and treat a patient while they're still in the clinic, Peña added. It's harder to engage patients in conversations about next steps over phone or a MyChart chat, oftentimes days after the initial appointment.
Although she was ready to use Truvian in her clinic "yesterday," Peña expects some skeptical patients.
"I'm probably going to keep all the studies right next to my machine to make sure that we can quote them," Peña said. "But honestly...you don't see what happens in the back of the lab when you give blood in a big, central lab."
With Truvian, she continued, patients can watch it work. Nothing is "hidden behind the scenes."
What's Next for Truvian?
On January 17, I connected with Marrinucci and Srinivasan for one last conversation. They're preparing to submit for FDA approval at the end of the quarter, with hopes of bringing the device to market in 2026.
It's been a long road, Srinivasan told me, but medicine is built on the Hippocratic Oath: "First, do no harm."
"Everything we do is very deliberate to ensure that we do the right things the right way and take no shortcuts," Srinivasan said.
When I asked the pair what they consider the hallmark of their story, Marrinucci brought up two major concerns for patients and providers: chronic disease and personal agency.
A lot of patients who test Truvian's device are disappointed when the results indicate suboptimal health, according to Marrinucci.
"Your blood tells your story," Marrinucci said, "but your blood's not forever.
"It just tells you where you are today," she continued. "Now you know, and you're empowered to make whatever decisions that you need to make to improve your overall health. Now, you have the power to do that."
