April 22, 2025 | The clinical relevance and limitations of so-called “lab-in-a-box” (LIAB) diagnostics, which surged in popularity during the COVID pandemic, have since that time been under considerable scrutiny, most notably among investors still spooked by the notorious Theranos scandal. One of the more enduring problems among LIAB developers is that they tend to get “blinded by the beauty” of their technology, according to Larry Worden, principal and founder of marketing research and consulting firm IVD Logix.
Far too often, they never stop to consider what critical unmet need their system or specific assay is going to fill—for example, shortening the time to diagnosis from three days to two hours or letting emergency room (ER) physicians know which patients they can safely send home so they concentrate on those needing medical attention. “To try to be all things to all people is probably self-defeating; [companies] need to be much more focused and directed toward particular kinds of diseases or situations like critical care,” Worden says.
Perspectives on LIAB diagnostics from the vantage point of all major stakeholder groups will be among the topics of discussion at the upcoming Next Generation Dx Summit in Washington, D.C., where Worden will be chairing the Enabling Point-of-Care Diagnostics track. The related topic of mobile services for precision medicine, or what he terms “lab-in-a-truck,” will also be featured.
A lab-in-a-box diagnostic “means different things to different people,” notes Worden, and is also the name Labcorp has given its all-inclusive venipuncture collection kit and transport system for home healthcare purposes. But generally, it suggests something along the lines of what Theranos tried unsuccessfully to create—a “Rube Goldberg machine that can take a drop of blood and do 50 to 100 different tests on it quickly in a pharmacy or physician’s office using microfluidics and various retention technologies, all under one SKU in one box. That’s a huge technological challenge.”
LIAB test kits are designed to meet the needs of point-of-care locations, such as doctors’ offices, which are fast-paced environments lacking any formal laboratory services, he continues. The assays must therefore be easy enough for even low-skilled employees to use and offer rapid turnaround across a wide number of analytes, to “put test results in the physicians’ hands while a patient is still in the office.”
Other likely venues would be urgent care centers, emergency rooms, and ambulances, and intensive care units who need tests “done quickly to get to a clinical decision,” says Worden. “The question, though, is what clinically urgent decisions hinge on knowing that test result.”
A troponin test done in the ER to detect and diagnose heart attacks is a classic example, producing an initial readout within minutes. Abbott’s i-STAT system, a portable point-of-care analyzer, tests for this and a wide range of blood parameters that are crucial to measure for the rapid diagnosis and management of critically ill or injured patients.
In physicians’ offices, perhaps 10 to 15 chemistry tests are routinely ordered—including a complete blood count, basic or comprehensive metabolic panel, lipid panel, thyroid tests, and urinalysis—which involves drawing blood and sending out the samples to Labcorp or Quest with results returned within the next 24 to 48 hours. “In most cases, it is not an urgent turnaround,” he says.
Rapid tests are used when results are needed in minutes to hours, such as for suspected strep throat or a sexually transmitted disease. If physicians are going to have to draw blood anyway on those same individuals, it diminishes the value of other LIAB diagnostics given their addition comes with a cost that isn’t necessarily easy to recoup, says Worden. The menu of the box needs to suit their patient population and disease focus, which differs from practice to practice.
On the critical care side, Polymedco’s PATHFAST analyzer measures various cardiac biomarkers to help ERs diagnose and assess the severity of conditions like heart attack, deep vein thrombosis, and pulmonary embolism and delivers results in under 17 minutes, Worden cites as an example. The high-sensitivity troponin cardiac assay, developed for the PATHFAST system, became the first such test approved by the U.S. Food and Drug Administration last year.
Point-of-care analyzers available from other companies, including Abbott and Siemens, focus on blood gas, electrolytes, hematology, and coagulation, Worden says. “I think the hope is to develop lab-in-a-box concepts by adding other commonly ordered tests such as basic and comprehensive metabolic panels, lipid profiles, thyroid tests, complete blood counts, urinalysis, glucose, strep, pregnancy, STIs [sexually transmitted infections], and respiratory infections.”
It is easier to recite what is dampening than driving the popularity of LIAB diagnostics, says Worden. “Reimbursement is of course key... [including] whether it covers the cost of labor to do the test.” But physicians also need a guaranteed return on the capital they lay out to put the technology in their practice in the first place, he adds.
LIAB testing additionally shouldn’t clog up patient flow at a physician practice by, for example, having bunches of patients waiting on-site for results. “These tests have variable time to results—some of them are very rapid, and some take 20 minutes, 30 minutes, or an hour, and doctors have a limited time with patients in the exam room,” he points out. “What do they do with patients while they are waiting for those results?” If the answer is to send them home and call them later, the practice might just as well send the test out for processing. Ideally, an analyzer offers results in 15 minutes or less.
Another limitation is licensure, says Worden. Doing a clinical lab test requires a CLIA license, or certificate, which comes in several forms. The basic license allows practices to do microscopic analysis only and the next level up to perform manual strep, hematocrit, and glucose tests.
Beyond that, including tests that involve advanced pre- or post-analytical steps or are deemed “moderately complex,” adoption would require a practice to have either a CLIA compliance or accreditation license. That necessitates having a designated medical director, which is “more onerous for a small practice.”
‘Only Part of the Puzzle’
If LIAB diagnostics become more commonplace at physician practices, routine testing for clinical trials could perhaps more often be done on-site rather than sent out for processing. But the value-add of a LIAB in that context, versus a phlebotomist taking a blood draw, seems unclear, says Worden.
For in-store medical clinics set up by retail pharmacies, the intended destination of the disgraced Theranos blood test, LIAB tests don’t appear to have much of a home to go to. CVS, Walgreens, and Walmart have all scaled back or shut down these operations, due primarily to their high operating costs, Worden says.
Meanwhile, original equipment manufacturers continue scouting for their niche. But it likely won’t be an “all-in-one panacea of a laboratory box that fits everything,” he says, but a specific disease category as has been the strategy of Polymedco and others.
More promising, in Worden’s mind, is the unique mobile lab-in-a-truck approach of Phronetik, which is focused on introducing next-generation sequencing and precision medicine to underserved areas to unabashedly improve diversity, equity, and inclusion in healthcare despite the current political climate. Genomics is “very skill-dependent,” which has been a huge barrier to get the technology more widely distributed and accessible to people who need it, he says.
LIAB capabilities are what most often come up in conversations IVD Logix is having with its customers, including companies developing point-of-care analyzers for a panel of respiratory viruses or sexually transmitted diseases. It is also a point of discussion with critical care labs, with whom IVD Logix works to better understand how diagnostics play into patient pathways and to gather feedback on how to improve analyzers and assays under development.
“One of the things that always impresses me is how insensitive we can be in diagnostics,” says Worden. “We often forget that lab tests are only part of the puzzle... [not] the whole gestalt of the diagnostic process. We must figure out how these technologies can enhance that whole process.”