Impact to waived lab with Lucira COVID-19 home use kit approval

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:

• Authorized prescription is required
• Only for patients suspected of COVID-19, not for asymptomatic testing
• Availability is extremely limited
• Insurance might not cover the cost of testing
• No everyone is comfortable doing in-home testing
• The estimated cost is about $50 or lower, but the exact cost is not confirmed

 
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.