FDA Lyme Testing update

5/18/2023

Email exchange between CDRH Ombusdman, Abiy Desta & myself.

I inquired about Lyme diagnostics and why we still don’t have viable, and reliable testing.  Since my last inquiry, 2/13/2020 the CDRH has approved 8 diagnostic kits from the following 3 companies:

Viramed Biotech AG

Gold Standard Diagnostics

DiaSorin Inc.

Ombudsman Desta says he’s not been able to find any recalls or device problem issues.   So with that, if these new tests have no issues, WHY ARE THEY NOT SCREENING BLOOD DONATIONS?  

4/1/2022

Emails we’re sent to (Dr. Jeffrey Shuren, Ms. Patricia Harley) in order to follow up and inquire why NOTHING has been done since my first contact in 2020.   
NO RESPONSE.