Challenges Loom for Point-of-Care Diagnostics

July 1, 2016
Challenges Loom for Point-of-Care Diagnostics
POC is likely to grow in emerging markets, where limited resources and local conditions make traditional lab-based testing less practical. [pixelfusion3d / Getty Images]

Alex Philippidis

Spartan Bioscience is gearing up to launch what it calls the world’s smallest commercial molecular diagnostics device, a coffee cup-sized portable testing tool called the Spartan Cube.

Should the Cube live up to its vision of enabling anyone to quickly perform DNA testing, as the company declared May 31, it could further disrupt an already-growing market for point-of-care molecular diagnostic tests—a market that is projected to more-than-triple to $3.9 billion by 2024, up from $1.2 billion last year, according to Grand View Research. Rosy forecast aside, point-of-care molecular diagnostics still face numerous challenges that threaten to slow down the expected future growth and lessen its odds of widespread adoption by healthcare providers.

Those challenges should be overcome, Grand View noted, through growing demand for POC molecular diagnostics (MDx) usable outside laboratory settings, such as pharmacy clinics, physician offices, and home care; continued funding of new technologies by developed countries and private sources; and ongoing R&D to miniaturize molecular diagnostics. Spartan’s Cube, for example, is just 4 inches cubed.

“Spartan’s vision is bringing the power of DNA testing to everyone and we believe the Cube will do that,” Spartan CEO and founder Paul Lem, M.D., told Clinical OMICs. “Our initial test menu focuses on the infectious disease, pharmacogenetics, and food and water testing markets. But as a platform technology, these are just three possible applications out of many.

The Cube is a PCR-based platform designed to go from sample to result in 30 minutes. The Cube will be launched next month at the American Association of Clinical Chemistry (AACC) meeting in Philadelphia, and made available for purchase soon after. Spartan has not disclosed the Cube’s price, but says it will be significantly less than the $10,000 to $50,000 cost typical of DNA testing devices.

“The Cube will be affordable like a personal computer,” Lem said. “In the same way that mainframe computers gave way to personal computers, high-throughput DNA testing systems in central labs will give way to portable, on-demand DNA-testing systems.”

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