Molecular Methods : Analytical Principles and Test Design Considerations - 07/03/26

Doi : 10.1016/j.path.2026.01.002

Mine M. Yilmaz, MD ^a, Sidra Zaheer, MD ^b, Mahesh M. Mansukhani, MD ^c, Susan J. Hsiao, MD, PhD ^c,^⁎

^a Department of Pathology, Icahn School of Medicine at Mount Sinai, 1468 Madison Ave., Annenberg Building 15th Fl, New York NY 10029, USA

^b Department of Pathology, University of Arkansas for Medical Sciences, 4301 W Markham Street # 502, Little Rock, AR 72202, USA

^c Department of Pathology & Cell Biology, Columbia University Irving Medical Center, 630 West 168th Street, P&S 16-408CB New York, NY 10032, USA

^∗ Corresponding author. Department of Pathology & Cell Biology, Columbia University Irving Medical Center, 630 West 168th Street, P&S 16-408CB, New York, NY 10032. Department of Pathology & Cell Biology Columbia University Irving Medical Center 630 West 168th Street P&S 16-408CB New York NY 10032

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Saturday 07 March 2026

Abstract

In this article, the authors review the types of molecular alterations present in cancer and molecular methods used commonly in clinical diagnostic laboratories, including technologies such as next-generation sequencing and digital polymerase chain reaction. Additionally, the authors discuss considerations for test design, incorporating factors such as specimen type and biomarker type, to design a molecular test menu that delivers accurate and timely results in an efficient and cost-effective manner.

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Keywords : Molecular diagnostics, Test design, Methods, Next-generation sequencing, Polymerase chain reaction