2021 Volume 70 Issue 3 Pages 551-559
The development of molecularly targeted drugs has progressed rapidly in recent years. As for companion diagnostics especially in primary lung cancer, many of these drugs are prescribed. Kindai University has established in the Faculty of Medicine the Center of Genomic Medicine, which performs the companion diagnostics specialized for lung cancer. We have started to receive clinical examinations of markers such as PD-L1 (22C3), ALK (IHC), ALK (fluorescence in situ hybridization (FISH)) and EGFR. The center has received and tested 517 samples in its two years of operation, 365 (70.6%) of which contained a sufficient amount of malignant tumors to perform the examination successfully. The numbers of cases for which examinations were carried out were 81 for EGFR in seven months and 350 for PD-L1 (22C3), 278 for ALK (IHC) and 237 for ALK (FISH) in two years. It took 11.8 days (including Saturdays, Sundays and holidays on average to return the results of genomic examinations after receiving the formalin-fixed samples. However, it took only 7.73 days for EGFR. We obtained a turnaround time that is short enough compared with outsourcing. The Center of Genomic Medicine has stopped receiving new samples because we set up in our hospital a new department that will perform genetic screenings using a next-generation sequencer. We report the advantages and disadvantages of performing clinical examinations in our facilities, which we found through these approaches, by posting the possible problems associated with introducing these examinations in the center.
