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.
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.