OFFICE OF THE MAYOR
THE CITY OF NEW YORK

RAUL PEREA-HENZE, MD, MPH
DEPUTY MAYOR FOR HEALTH & HUMAN SERVICES

February 2, 2020
Dear Drs. Redfield and Jernigan:
This letter is following up on a verbal request made last week by our Health Commissioner, Dr. Oxiris
Barbot.
The Centers for Disease Control and Prevention (CDC) response to the outbreak of 2019-novel coronavirus
(nCoV) has been swift and robust and we sincerely thank the CDC teams that continue to work tirelessly to
understand this emerging virus, curtail its impact on human health, and protect the health of all Americans.
The ability to reliably detect infection in patients is central to controlling any infectious disease outbreak.
Thank you for all of the work being done to ensure that public health laboratories (PHLs) will soon have the
capacity to test for 2019-nCoV locally. CDC scientists have developed the test very rapidly as this virus has
emerged, and it is a testament to the strength of the science at CDC that a clinical test is ready within weeks of
the virus being identified and sequenced.
We commend the collaboration between the CDC, the Food and Drug Administration (FDA), and the Centers
for Medicare and Medicaid Services (CMS) to streamline the development, validation, and authorization of
clinical diagnostic tests that meet regulatory requirements in the rapidly evolving setting of an infectious
disease public health emergency. The efficiency of this process is being put to the test in this emergency.
We understand the importance of ensuring that any diagnostic test for 2019-nCoV infection is robust and
reliable and meets the strict standards set by the FDA under the Emergency Use Authorization (EUA) process.
We also understand that developing and validating a clinical diagnostic test takes time, and that it is critical
that the results from the test are reliable and accurate as clinical as well as public health action will be taken
based on these results.
As this public health emergency unfolds, it is critical that state and local PHLs have access to this test as soon
as possible to enable rapid testing of patients under investigation (PUI) for 2019-nCoV infection to ensure the
availability of reliable, actionable test results in real time. We are requesting that the deployment of this test
to PHLs be accelerated as much as possible. When the test is available at the New York City PHL, we be able
to have test results in hand within hours of specimen collection, faster than a specimen can even be shipped to
CDC for testing.
Providing PHLs with access to draft test documents, including draft standard operating procedures and test kit
inserts, and validation data before the final EUA is granted and the test kits themselves are available will

 enable laboratories to prepare drafts of the documents required for deploying the test locally. These drafts can
be rapidly updated and finalized by PHLs once the EUA is granted and the test is officially released, thus
decreasing the time between the EUA approval and local deployment of the test.
Pre-placement of the parts of the test kits that are already available from commercial manufacturers (i.e.:
nucleic acid extraction kits, Taq polymerase and master mix reagents, etc.) at PHLs will also accelerate the
deployment of the test once the EUA is granted and the test-specific reagents (i.e.: virus-specific primers and
probes) are manufactured and ready to be distributed.
We appreciate CDC’s commitment to ensuring that the 2019-nCoV test is deployed to state and local PHLs as
quickly and efficiently as possible to, in turn, ensure that our local, as well as the national, response to this
public health emergency is as effective as possible.
Thank you for your consideration of this request and for your ongoing partnership.

Sincerely,

2
CITY HALL  NEW YORK, NY 10007