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FDA Approves Ellume's At-Home COVID-19 Test | San Fernando Valley Business Journal


Ellume s test kit.
The U.S. Food and Drug Administration on Tuesday approved the first at-home COVID-19 test, developed by a biotech company with ties to the Valley region.
Digital diagnostics company Ellume Inc., which developed the test, is headquartered in Australia but has its U.S. offices in Valencia.
The $30 at-home test kit comes with a nasal swab and single-use Bluetooth-enabled test cartridge. It will allow people to test themselves for the virus without a prescription, Ellume said.
Data submitted to the FDA showed Ellume’s test to be 96 percent accurate, compared to emergency lab tests available. The company was able to fast-track test development with a $30 million grant from the U.S. National Institutes of Health Rapid Acceleration of Diagnostics initiative. ....

Amy Stulick , Drug Administration On , Ellume Inc , Drug Administration , Health Rapid Acceleration , ஆரோக்கியம் விரைவான விரைவுபடுத்துதல் ,