Developers of At-Home Tests Saw Progress in 2019, But Commercialization Challenges Remain - 360Dx

Developers of At-Home Tests Saw Progress in 2019, But Commercialization Challenges Remain - 360Dx


Developers of At-Home Tests Saw Progress in 2019, But Commercialization Challenges Remain - 360Dx

Posted: 02 Jan 2020 12:00 AM PST

NEW YORK – Relatively few tests marketed for use at home have been cleared by the US Food and Drug Administration, but test developers in 2019 continued to innovate, collaborate, and raise funds in anticipation of future successes.

According to diagnostic test developers, more at-home tests, sometimes referred to as self-tests, need to demonstrate affordability and have levels of performance as high as, or better than, laboratory tests to achieve regulatory clearances and market acceptance.

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