Maria E Arcila, Utsav Patel, Amir Momeni-Boroujeni, JinJuan Yao, Roger Chan, Joe Chan, Ivelise Rijo, Wayne Yu, Nelio Chaves, Hina Patel, Srushti Kakadiya, Sean Lachhander, Brigitte Senechal, Isabelle C Riviere, Xiuyan Wang, Michel Sadelain, Khedoudja Nafa, Paulo Salazar, Lia Palomba, Kevin J Curran, Jae H Park, Anthony Daniyan, Laetitia Borsu
Although in-vivo engraftment, expansion, and persistence of CAR T cells are pivotal components of treatment efficacy, quantitative monitoring has not been implemented in routine clinical practice. We describe the development and analytical validation of a digital-PCR (dPCR) assay for ultra-sensitive detection of CAR constructs post-treatment, circumventing known technical limitations of low partitioning platforms. Primers and probes, designed for detection of axicabtagene, brexucabtagene and MSK CAR constructs, were employed to validate testing on the Bio-Rad dPCR low-partitioning platform; results were compared to Raindrop, a high-partitioning system, as reference method...
June 15, 2023: Journal of Molecular Diagnostics: JMD