In Reply.— In response to the recent letter to the editor by Christina M. Lockwood, PhD, DABCC, DABMGG, regarding our manuscript “Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, Food and Drug Administration Regulations, and Clinical Laboratory Performance,”1  we appreciate your attentiveness in identifying the oversight that is described in your correspondence.

Our editorial aimed to navigate the complexities of proficiency testing for next-generation sequencing lab-developed tests, underlining their role in ensuring diagnostic integrity. The error pointed out highlights a nuanced idea we intended to convey: the necessity for alternative proficiency testing in scenarios where existing proficiency testing may not fully capture an assay’s performance. This subtlety, unfortunately, was not as clear as we hoped, because the example we used was inadequate. We are grateful for the chance to clarify our discussion.

1.
Harada
S,
Mackinnon
AC.
Navigating next-generation sequencing laboratory developed: a critical look at proficiency testing, US Food and Drug Administration regulations, and clinical laboratory performance tests
.
Arch Pathol Lab Med
.
2023
;
148
(
2
):
136
138
.