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.
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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In the past few weeks, we have been getting phone calls daily on how to start up Temporary Sites/Mobile COVID testing lab. The popularity of Temporary Sites/Mobile testing is driven by the increasing number of FDA EUA point of care testing options and the need to improve access to COVID-19 testing especially for return to work and safe reopening. Here are some advantages in starting up Temporary Sites/Mobile COVID testing labs.
Startup: We had helped labs obtain CLIA certification and complete setup Temporary Sites/Mobile COVID testing lab in less than one week. Supplies: Testing supplies can be obtained within 1-2 week. We had contact with distributors that can help your lab, obtain both waived antigen and antibody test kit. Reimbursement: We had helped labs gaining access to reimbursement through government programs and private insurances. The holiday season and the rising case of COVID-19 had increased demand for testing, which created opportunities for Temporary Sites/Mobile COVID labs. But the window of opportunity to COVID-19 testing lab is not going to be here for long, the COVID-19 vaccine has been submitted for FDA EUA approval and the recent FDA approval of at home COVID-19 testing means likely the mobile testing market would only be demanded until around spring/summer of next year. If you are an entrepreneur wanting to tackle the COVID-19 crisis, give us a call 909-294-8890 or email CLIALabConsultant@gmail.com for a consultation. |
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. Archives
April 2024
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