On 11/17/20 the FDA issued EUA to Lucira Health All-In-One Test Kit, this is the first test kit allowing anyone over 14 years old to perform self-testing at home. This is definitely a game-changer and many entrepreneurs planning to startup and mobile/pop up lab owners are trying to understand the impact this will have on their business model moving forward. While the technology and the FDA approval are a game changer, but the impact of Lucira approval will be likely minimal in the near future and shouldn’t discourage anyone from starting up a lab. There is still a lot of barriers to break through before the test can make an impact:
At home testing isn’t the end of the mobile/pop up COVID lab, there are still opportunities to open up your own mobile and pop up COVID lab.
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Michael Yu, MS, MBA, MLS(ASCP)
Michael is the founder and owner of CLIA Lab Consultant where he provides consultation to laboratories and companies world-wide for startup and lab regulations, reimbursement, and testing strategies.