February 24, 2020
Stephen M. Hahn, MD
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Commissioner Hahn,
On behalf of our nation’s state and local public health laboratories (PHLs), we are writing to urge you to consider
enforcement discretion to allow this select group of governmental laboratories the ability to create and implement
a laboratory developed test (LDT) for the detection of SARS-CoV-2 (COVID-19). We recognize the gravity of the
current COVID-19 situation across the globe and wish to have greater diagnostic capability for both surveillance
and for patient diagnosis across the United States, hence this extraordinary and rare request.
While we appreciate the many efforts underway at CDC to provide a diagnostic assay to our member labs under
the Emergency Use Authorization (EUA), this has proven challenging and we find ourselves in a situation that
requires a quicker local response. We are now many weeks into the response with still no diagnostic or
surveillance test available outside of CDC for the vast majority of our member laboratories. While we understand
that the EUA process is open to PHLs, we believe a more expeditious route is needed at this time.
To the extent possible, public health laboratories could work together to:
o
o
o
o
o

Utilize a standard protocol or use a limited set of protocols
Purchase reagents including primers and probes from a common source
Utilize a standard validation panel
Recommend a minimum standard validation approach
Enable confirmation at another PHL while cases remain sporadic. It is also possible to consider the
use of LRN advanced labs to serve as a confirmatory lab if resources are available to do so.

We recognize that not all PHL’s will develop and implement an LDT. If PHL’s decided against the use of an LDT for
whatever reason, they could: 1) wait for the availability of the new CDC replacement kit, 2) coordinate with a PHL
that has developed an LDT (this is not uncommon for PHLs to work together), or 3) use a commercially available
assay once approved by FDA under an EUA.
We look forward to discussing this request with you and your staff as soon as possible. If you have questions,
please contact Scott Becker at 301-526-5704 or via email at scott.becker@aphl.org.
Sincerely,

Grace Kubin, Ph.D.
Director, Laboratory Services Section
Texas Department of State Health Services
cc:

Scott J. Becker, MS
Chief Executive Officer
Association of Public Health Laboratories

Robert Redfield, MD, Director, Centers for Disease Control and Prevention

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