Development and validation of qPCR methods for nucleic acid biomarkers as a drug development tool: points to consider
Yuchen Sun, Takahiro Nakamura, Yoshiaki Ohtsu, Masaaki Kakehi, Noriyuki Danno, Hiroyuki Shimizu, Yoichi Tanaka, Victoria Serelli-Lee, Seiji Tanaka, Takashige Okayama, Yusuke Suda, Yuu Moriya, Takeshi Hanada, Yoshiro Saito- Medical Laboratory Technology
- Clinical Biochemistry
- General Pharmacology, Toxicology and Pharmaceutics
- General Medicine
- Analytical Chemistry
Nucleic acid (NA) biomarkers play critical roles in drug development. However, the global regulatory guidelines for assessing quantification methods specific to NA biomarkers are limited. The validation of analytical methods is crucial for the use of biomarkers in clinical and post-marketing evaluations of drug efficacy and adverse reactions. Given that quantitative polymerase chain reaction (qPCR) and reverse transcription qPCR (RT-qPCR) methods are the gold standards for the quantification of NA biomarkers, the Biomarker Analytical Method Validation Study Group in Japan has discussed considerations and made recommendations for the development and validation of qPCR- and RT-qPCR-based analytical methods for endogenous NA biomarkers as drug development tools. This white paper aims to contribute to the global harmonization of NA biomarker assay validation.