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Is it too late to start a molecular COVID lab?

11/28/2020

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I was asked if it was too late to start up a molecular COVID lab with the vaccine under review by the FDA and existing labs being more prepared for higher volume. The answer is no, there is still time to start up a molecular COVID lab to recoup the startup cost and be profitable. There are advantages for labs that are starting up now. 
  • More options for FDA EUA equipment and reagents including saliva testing and pooling 
  • Positive samples for validation is readily available along with the other validation material 
  • Vendors and consultants had more experience in COVID lab setup which can lead to quicker set up time. (We had setup both waived and non-waived COVID-19 molecular/antibody testing labs)
  • CLIA application processes are shorter than usual, even for those with state regulations. 

​Starting a business is fraught with risks and especially in times of uncertainty like a pandemic. On the other hand, uncertainty also creates significantly more reward opportunities for those willing to take on the risk. At CLIA Lab Consultant we go beyond ensuring your lab is compliant with all regulations, but also for financial viability as well.
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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. 

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