FDA template copy here: https://www.fda.gov/media/140615/download
Criteria within the template outlines that, "This template is intended for testing with respiratory specimens or saliva; if you are considering non-respiratory specimens (e.g., blood, stool, etc.), please contact FDA at CDRH-EUA-Templates ([email protected]) to discuss your validation strategy".
So this template announcement is not for Access Bio (Atomo) kit since its a blood based test. However, no doubt Access Bio would be pursuing emergency FDA approval for its kit as advised by John Kelly in the partnership announcement + IRD Investor presentation yesterday.
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