A new approach for the detection of genetic alterations utilizing modified loop-mediated isothermal amplification reaction (LAMP).

The increasing use of genetic testing for personalised therapy, highlights the need for rapid, reliable diagnostics. Current methods are hindered by complex workflows, requiring advanced equipment, skilled personnel, and invasive tissue sampling. Loop-mediated isothermal amplification (LAMP) has emerged as a more efficient alternative to traditional PCR. LAMP eliminates thermal cycling, allowing faster, more cost-effective tests, and is less sensitive to inhibitors, enabling testing from minimally processed samples. Although LAMP is newer and has a longer assay development time than PCR, its potential in oncology, particularly for detecting genetic changes, is promising. We have developed a LAMP-based method for detecting genetic variations, optimized for point-of-care testing. This technique uses modified primers with alterations at the 3' end of either F2 or B2 primers, ensuring specificity for altered sequences. The assay only produces a positive signal when the genetic variant is present, distinguishing it from wild-type DNA. Our findings demonstrate that this method has high specificity and sensitivity, even in samples with both wild-type and mutated material. Paired with a portable device, this LAMP-based diagnostic method could revolutionize genetic alteration detection, offering quicker results and improving treatment outcomes, particularly for targeted therapies.