03 Apr 2020
Posted in Medical Devices
Rapid diagnostic tests to greatly increase testing capacity for diagnosing COVID-19
There is a current worldwide lack of testing capacity for the novel coronavirus (COVID-19) outbreak. The frontline response for diagnosing COVID-19 has been polymerase chain reaction (PCR) testing. Although PCR is the go-to test for diagnosing an infectious agent, the test protocol is complex and expensive as it is mainly suited to large, centralized diagnostic laboratories, and tests typically take four to six hours to complete, says GlobalData, a leading data and analytics company.
The solution to a paucity of testing is rapid point-of-care (POC) tests, which will accelerate clinical decision-making and take some of the workload off centralized test laboratories. The Foundation for Innovative New Diagnostics (FIND), a Geneva-based not-for-profit that supports the development and delivery of diagnostics to low-income countries, is aiding the development effort, and has already received 220 manufacturer submissions.
Dara Lo, Medical Devices Analyst at GlobalData, comments: “While immunoassays are less accurate than PCR and take longer to develop, they are easy to use and can deliver results in under 20 minutes. The speed and versatility of immunoassays make them invaluable tests and efforts to produce them on a massive scale are beginning to ramp up.”
The Food and Drug Administration (FDA) recently outlined four pathways for COVID-19 tests, which will greatly increase testing capacity. The pathway for commercial manufacturers of COVID-19 tests allows the manufacturer to launch its test and platform as soon as it is validated, notify the FDA and submit an emergency use authorization application within 15 days. This pathway applies to molecular, antigen and antibody tests that can be used in clinical labs and at the point-of-care. This pathway, however, does not apply to tests intended to be used in the home.
Lo concludes: “Developers of rapid tests continue to gain traction, with these tests making up more than half of the products in the development pipeline and over 30% of currently marketed in vitro diagnostic tests. GenMark Diagnostics and Mesa Biotech are the first to bring a POC test to the US market, but Chembio has their dual system in the wings, offering a powerful tool suitable for the physician office. Cepheid and Biofire Diagnostics are likely to grab a share of the small lab market as well, as their tests become available.”