Comprehensive Summary
This study focuses on exploring methods to overcome the limitations of standard HER2 testing for anti-HER2 therapies via PCR quantification. Researchers used Lab-On-An-Array digital real-time PCR (drPCR) to devise a precise HER2 testing method. They analyzed accuracy and efficiency of different techniques using AI algorithms, sequencing, and droplet digital PCR. The drPCR was developed by designing primer-probe sets that targeted ERBB2 and reference DNA regions, which were able to detect HER2. Through these methods, it was found that drPCR had a higher predictive accuracy compared to previous HER2 testing methods, such as dPCR, resulting in statistically significant reliable results with high reproducibility. Its accuracy was further proven by comparing results with NGS and FISH, other methods used to determine optimal cutoff for drPCR assay. NGS was not able to detect low level ERBB2 amplification, and also returned false-positive data, showing the higher accuracy of drPCR. As such, drPCR is a promising method that offers an easier and more accurate reading of ERBB2 measurement, leading to a more precise determination of HER2 status for a better response to anti-HER2 therapy.
Outcomes and Implications
This research is pertinent as it addresses the issue of the inaccuracy and time-consuming nature of anti-HER2 therapies. The drPCR technique is an innovative method that can not only decrease the amount of false-positives and false-negatives, but also better the treatment used towards these patients. It is able to improve treatment responses of HER2, as shown by the results between HER2 drPCR(+)/IHC-ISH(+) and HER2 drPCR(-)/IHC-ISH(+) groups, with the latter exhibiting poor treatment responses. Furthermore, drPCR can also identify patients with chromosome 17 centromere abnormalities, paving the way for future technologies to follow in its footsteps.