Overcoming The Diagnostic Dilemma With Point-Of-Care Testing

Meeting the needs of patients, providers, and payers will be key to overcoming the limitations of current point-of-care (POC) testing methods, according to keynote speaker Timothy Still, CEO of Sense Biodetection, on the opening day of the Next Generation Dx Summit in Washington, D.C. Many of the longstanding obstacles—including limited research funding, dependency on central labs, and general unfamiliarity with diagnostic testing—have already been resolved by the ongoing pandemic.

COVID cash has been easy to come by from the federal government as well as the private sector, which has been abuzz with merger and acquisition activity, he says. By 2027, the POC diagnostics market globally is expected to reach $72 billion.

Primary care, which used to be a "difficult sell... is all over the map now," says Still, driven by decentralization of healthcare. The virtues of molecular versus antigen tests have become topics of everyday discourse.

Testing has moved to POC settings due to the barriers associated with central labs, notably the time it takes to get results, Still continues. A small group of POC pioneers decades ago sought to bring testing closer to patients and make the business of diagnostics more efficient and convenient.

The history of POC testing began in 1962 with the introduction of Accu-Chek blood glucose meters and has been highlighted by the first rapid pregnancy test in 1977, and tests for flu and other respiratory diseases in the 1980s, he says. Importantly, the Clinical Laboratory Improvement Amendments (CLIA) of 1988 also provided a certificate of waiver for tests that could be done by someone with a seventh-grade education level in 20 minutes or less.

Still himself was involved in the development of Cholestech, the first CLIA-waived, multianalyte diagnostic for cholesterol and related lipids. This was followed in the 1990s by the practice of lipid testing in the emergency room as cholesterol-lowering products (Pfizer's Lipitor and Merck's Zocor) were hitting the market so patients could be treated on the spot. The diagnostics arsenal expanded thereafter to other conditions, including metabolic syndrome and cancer.

Many companies, including Mesa Biotech and Cepheid, have produced advanced, state-of-the-art technologies for POC testing, says Still. The decades-long challenge has been how to get solid assay performance.

Among the latest technologies on the scene are CRISPR (clustered regularly interspaced short palindromic repeats), LAMP (loop mediated isothermal amplification), and single strand endonuclease (the methodology used by Sense Biodetection). "Diagnostics is an information business," not making better technology for the lab, Still says.

Consumer Shift

A "meteoric rise" in consumerism has made people digitally resourceful about virtually everything—shopping, payment and cost sharing, travel and lodging, and food and dining, as well as healthcare, he points out. During the pandemic, online grocery sales were up 42% while in-store sales fell 14% ("It's not a zero-sum game") while online health education rose by 91% and one-fifth of those information seekers downloaded at least one app.

Features of the great consumer shift include not just the preponderance (53%) of private health insurance plans but $100 billion in health savings account assets, federal price transparency initiatives, consumer-focused quality measures, and changing social perceptions about traditional institutions, says Still.

But age is certainly a factor. Among individuals 65-plus, 65% trust their primary care physician to provide all their healthcare information. Younger generations search online and shop around. The healthcare ecosystem also looks a lot different than it once did, says Still, including digital options for low acuity care (telehealth) and chronic disease management.

Despite those changes, problems persist for POC testing related to clinical workflow, the need to redo tests, and the long wait for answers, in addition to health equity and access issues, he says. "It's hard to meet patients where they're at." Much of the older equipment doesn't come to the consumer, unlike newer diagnostics that might literally be worn on the wrist.

Three Pillars

Breakthroughs can shift the diagnostic dilemma, says Still, who imagines a new era of instrument-free molecular testing that is "pure consumable." That means eliminating all the operational challenges by creating devices that require neither calibration nor power.

That's the aim of the Sense assay, which can be performed in 15 minutes or less and deliver results as accurate as a central lab, he says. It could ultimately be applicable to all kinds of conditions, but initially will be specific to COVID and other types of respiratory diseases.

While well positioned for success, Still adds, the technology is still emerging, and some people question the accuracy of molecular diagnostics. Sense Biodetection intends to define that in an "end-to-end way," including how data pieces get to the healthcare system.

As with any POC test, issues of privacy will need to be addressed (individuals may not want to ask their doctor for an STD test, for example). The test will need utility for preventive and asymptomatic disease and have "prescriptive direction" for the results produced.

It is tough to know where POC testing is going, says Still. But his perspective after 30 years in the industry is that it will inevitably rest on three pillars: The assays will be good for patients (the right diagnosis at the right time from anywhere), incorporate providers (improved workflow, quality of a central lab, and not a big expenditure), and meet the needs of payers (by being cost efficient and informing diagnosis and treatment).