The Biden administration introduced Monday that it’s investing $230 million in Ellume, an Australian firm, for hundreds of thousands of its at-home coronavirus testing kits.
The deal, struck by the Division of Well being and Human Providers and the Division of Protection, ensures 100,000 over-the-counter check kits will arrive within the U.S. beginning this month by means of July, performing Facilities of Medicare and Medicaid Providers Administrator Andy Slavitt mentioned Monday throughout a White Home briefing.
Extra check kits are anticipated as manufacturing ramps up, Slavitt mentioned. Ellume is predicted to make 19 million check kits a month, with a complete of 8.5 million check kits arriving within the U.S. by the tip of the yr. In accordance with Slavitt, the check might be carried out at residence with a greater than 95% accuracy charge in people who’re displaying signs. It will likely be bought over-the-counter, and individuals who use them can anticipate outcomes again on their smartphones inside quarter-hour.
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“Making easier-to-use exams out there to each American is a excessive precedence with apparent advantages,” Slavitt mentioned.
Slavitt additionally mentioned the mechanics of the Ellume check are “much less invasive” than different COVID-19 exams that use lengthy, nasal swabs, as an alternative choosing a shorter nasal swab.
The Meals and Drug Administration initially granted emergency use authorization for the check in December, the primary of its variety within the U.S. Whereas the check is greater than 95% correct in folks with signs, it’s barely much less correct in those that are asymptomatic. In accordance with Ellume, the check has a sensitivity of 91% and a specificity of 96% in asymptomatic folks. It’s applicable to be used by folks ages 2 and up.
“This stage of accuracy throughout each symptomatic and asymptomatic people is essential in mitigating the unfold of an infectious illness like COVID-19, which might be unfold unknowingly,” Ellume mentioned in December.