Wolf&Grayson EditorialInfectious disease diagnosis still runs on a delay that nobody in medicine defends but almost everyone tolerates. A patient presents with a sore throat, a wound infection, a urinary complaint, and the clinician either guesses and prescribes empirically or sends a sample away and waits. The industry’s answer has been to shrink laboratory machines and push them closer to the clinic, a solution that keeps the refrigeration, the technicians, and the capital expense intact. Dr. Leonard E. Weisman argues that the real opportunity lies somewhere else entirely: a handheld, disposable device running real-time quantitative polymerase chain reaction (qPCR) on an interchangeable cartridge, capable of returning four or five targets plus a control in 15 minutes. The distinction matters commercially as much as clinically, because it changes who can run a test, where, and at what reimbursement.
Why Fewer Targets Is The Smarter Design Choice
The instinct in diagnostics has been to chase breadth. Laboratory platforms now detect 30 to 40 targets on a single panel and bill for all of them. Weisman’s read is that most of that breadth is informational rather than actionable. “Most of the time, you can’t really treat all those 40 or 50 causes,” he says. “It’s really just there to kind of know. So most of our tests are focused on what’s needed to make a decision for therapy. And that’s really just a handful of targets.”
That constraint is also a reimbursement strategy, and it is worth understanding why. The Centers for Medicare & Medicaid Services, a US federal agency, does not allow more than five targets at one point in time without advance approval from the insurer, which means a wide panel run at the point of care creates an administrative burden before the clinician has even seen a result. Designing to five or fewer sidesteps that friction, and the diagnostic yield holds up. Weisman uses urinary tract infection as the illustration: five targets would cover roughly 94 to 95 percent of cases. Not complete, but enough to treat, and available while the patient is still in the room. The same logic extends to respiratory illness, diarrhea, and wound infection, each of which can be served by a purpose-built cartridge rather than a universal panel.
The Science Underneath Is The Whole Argument
Point-of-care molecular testing has a credibility problem, and it was earned. A wave of devices arrived during COVID, Cue and Detect among them, running what Weisman calls LAMP (loop-mediated isothermal amplification) PCR. “It’s not really PCR, it’s PCR-like,” he says, and the performance showed it. His verdict on the underlying chemistry is blunt: LAMP is “an unproven technology that isn’t as accurate. It’s a little bit more accurate than rapid antigen tests, but it’s not anything near what a real-time qPCR assay is.”
Rapid antigen tests fare worse in his assessment, and the reason is instructive for anyone reading diagnostic performance data. During a pandemic, when prevalence is extremely high, antigen tests looked useful because nearly everyone tested was genuinely positive. Outside that window, the false negatives and false positives pile up. Weisman points out this was visible not only in COVID but in the swine flu epidemic of the early 2000s. The lesson for health systems evaluating point-of-care vendors is that validation generated during a surge may say little about how a device functions in ordinary clinical conditions. Weisman’s own standard for moving qPCR out of the laboratory is mundane and procedural: confirm the cartridge works on the device, confirm the device is accurate, and confirm the combination is accurate. “It’s basically testing and confirmation of what you assume will happen.”
Where The Technology Lands First, And Why Not Healthcare
The commercialization sequence Weisman describes is the part healthcare leaders should study most closely, because it inverts the expected order. The device is heading first into the farming and poultry market, chosen for its low regulatory requirements, then onto the battlefield. Grant funding from the UK government currently covers both of those applications, with discussions underway for support from various US agencies. Human healthcare in the US, EU, and UK comes last, with a hoped-for launch in roughly a year.
That sequencing buys something that cannot be bought later: field evidence. It also plays to the architecture’s real advantage, which is adaptability. Weisman notes that battlefield wounds in Afghanistan differed from those in Iraq, not entirely, but enough to matter for what a cartridge should look for. A handheld platform with swappable cassettes can be tuned to the environment it is deployed in, which a fixed laboratory panel cannot. The same mechanism is what makes it an outbreak tool. Given the genetic code of a new virus or bacterial pathogen, Weisman says his team can develop a cassette in two to six weeks. Set that against the COVID experience, where, in his words, “it took a really long time to develop anything and the quality of what they developed wasn’t as good as it could have been.”
For procurement teams, pandemic preparedness planners, and anyone writing diagnostic strategy for the next three years, the practical question is no longer whether molecular testing can leave the laboratory. It is which chemistry a given device runs, how many targets it reports and what that does to reimbursement, and how quickly the manufacturer can turn a novel sequence into a validated cartridge. Those three answers separate a genuine point-of-care platform from a smaller box with the same old constraints. Weisman’s position is that the market has repeatedly mistaken the second for the first, which has resulted in limited access and sales. While shortcuts in testing (e.g. LAMP PCR or rapid antigen testing) versus gold standard testing (e.g. qPCR or ddPCR) have paid for their error in false negatives.
Follow Dr. Leonard E. Weisman on LinkedIn for more insights on point-of-care molecular diagnostics, multiplex panel design, and rapid-response infectious disease testing.
