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OTC Diagnostics Forecast: Growing With Pandemic But High Bar For Approval Could Slow Spread

 
• By Malcolm Spicer

Sample-collection kit and testing firms acknowledge regulatory approval for OTC sales can be as complicated as the technology behind their products. But consumers have OTC access to numerous at-home collection kits for tests for indications of diseases or medical conditions as well as for genealogy. Kits approved for testing for influenzas or other infections also should become available OTC, say industry stakeholders.

Pixel is the first at-home collection kit for COVID-19 allowed for OTC distribution in the US nearly a year after national health emergency was declared due to the pandemic.

Consumer demand for home-use COVID-19 tests points to a growing market for OTC diagnostic products following the end of the novel coronavirus pandemic, one that medical technology providers are targeting.

Sample-collection kit and testing firms acknowledge, though, that regulatory approval for direct-to-consumer sales can be as complicated as the technology...

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