To the Editor.—In the recently published editorial “Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance,” an inaccuracy was noted.1 

The following statement in the editorial—“For example, with the increasing prevalence of advanced forms of NGS testing like cell-free DNA analysis, there is a growing need to establish complementary or alternative PT assessment programs when an existing CAP PT is either not available or unsuitable for some reason”—is not correct.1  The College of American Pathologists has provided proficiency testing for cell-free tumor DNA testing titled “Cell-free Tumor DNA (CFDNA)” since 2018 and has more than 100 laboratories enrolled, domestically and internationally2  (Figure).

Description from the College of American Pathologists catalog, used with permission from the College of American Pathologists. Copyright 2024.

Description from the College of American Pathologists catalog, used with permission from the College of American Pathologists. Copyright 2024.

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Thank you for the opportunity to provide clarity on this issue.

1.
Harada
S,
Mackinnon
AC.
Navigating next-generation sequencing laboratory developed tests: a critical look at proficiency testing, US Food and Drug Administration regulations, and clinical laboratory performance
.
Arch Pathol Lab Med
.
2024
;
148
(
2
):
136
138
.
2.
Devereaux
KA,
Souers
RJ,
Merker
JD,
et al.
Clinical testing for tumor cell-free DNA: College of American Pathologists proficiency programs reveal practice trends
.
Arch Pathol Lab Med
.
2023
;
147
(
4
):
425
433
.

Competing Interests

The author has no relevant financial interest in the products or companies described in this article.