Ma et al. (2022) published “Tailored therapy for Helicobacter pylori eradication,” a systematic review and meta-analysis suggesting that a tailored therapeutic approach might provide a better eradication success rate than empirical therapeutic methods in the first-line treatment regimen for H. pylori. To be considered a first-line treatment for H. pylori, a regimen must have an eradication rate of at least 80%–85% (Fallone et al., 2016). Therefore, various guidelines for the treatment of H. pylori recommend antibiotic susceptibility testing prior to therapy initiation to maintain high eradication rates (Jones et al., 2017; Kato et al., 2019; Kato et al., 2020; Jung et al., 2021; Romano et al., 2022). In recent guidelines for the treatment of H. pylori, non-bismuth quadruple therapy, sequential or concomitant treatment, and bismuth quadruple therapy is recommended as first-line treatment regimens in areas where clarithromycin (CAM) resistance mutations cause >15% of all cases (Malfertheiner et al., 2017; Liu et al., 2018). However, there are concerns that the inappropriate use of antibiotics may eventually lead to drug resistance. Because the overall H. pylori antibiotic resistance rates for CAM are 17.2% (95%, confidence interval 16.5%–17.9%) (De Francesco et al., 2010), it is necessary to consider performing a CAM resistance test before eradication therapy for H. pylori.

With increasing CAM resistance worldwide, CAM resistance tests are becoming vital. However, there is concern regarding antibiotic susceptibility testing, which is the basis of tailored therapy for H. pylori as shown by Ma et al. (2022).

The possibility reported by Ma et al. (2022)—tailored therapy that might provide a better eradication rate than empirical methods in the first-line treatment regimen for H. pylori—is important because it would inhibit bacterial growth through the appropriate use of antibacterial drugs. However, implementation in clinical settings would be difficult.

We developed a new reagent for evaluating H. pylori genes and CAM resistance mutations, using stool samples, developed as a dedicated reagent for the Smart Gene™ point-of-care testing kit (Kakiuchi et al., 2020; Kakiuchi et al., 2022). Smart Gene™ (Mizuho Medy Co., Ltd., Tosu-City, Saga, Japan) was invented in accordance with the idea of point-of-care testing, and it can mechanically do nucleic acid extraction and amplification and detection of the target genes. It is compact, light, and cheap gene detection equipment ($4,500 per unit). The reagent used in Smart Gene™ for H. pylori is also inexpensive, costing around $25 per sample. To the best of our knowledge, this is the world’s first reagent for point-of-care testing capable of rapidly detecting H. pylori genes and CAM resistance mutations. The assay is based on PCR and the quenching-probe technique, which detects H. pylori genes and CAM resistance mutations concurrently in about 50 min per sample. The measurement time is far briefer than those of conventional methods.

Similarly, Tsuda et al. developed a kit that can detect H. pylori genes and CAM resistance mutations in gastric fluid samples using Smart Gene^TM within 60 min (Tsuda et al., 2022). The test kit, combined with EGD, can be beneficial for the determination of CAM resistance mutations when it is difficult to test for these by culturing. Another major advantage of this method is that results can be obtained faster than with culture methods.

In order to expand tailored therapy for H. pylori eradication, it is essential to further develop and expand simple and economical methods that can test the antibiotic susceptibility of H. pylori.