Reviewed by Danielle Ellis, B.Sc.Sep 9 2024
According to a study published in Small Science, Dr. Min-young Lee and Dr Sung-gyu Park of KIMS's Advanced Bio and Healthcare Materials Research Division have created a method based on plasmonic nanomaterials for optical signal amplification that can identify cancer mutant genes in blood with the highest sensitivity in the world—0.000000001%.
Assay process of the EGFR mutation multi-analysis chip. Image Credit: Korea Institute of Materials Science.
The researchers examined blood samples from lung cancer patients (stages 1-4) and healthy people for EGFR mutations, with a diagnosis accuracy rate of 96%.
Early-stage cancer patients were difficult to identify because previously used genetic analysis tools had limited analytical sensitivity to detect altered genes compared to normal genes. In addition, the high cost, extended duration of analysis, and requirement for specialized equipment made it challenging to develop a prompt treatment plan and apply it to screening tests.
With an ultra-high sensitivity of 0.000000001%, the study team overcame these obstacles by creating a low-cost analysis method that can assess different cancer mutations inside the target gene area in less than an hour.
With the blood of lung cancer patients, the prospect of early detection was established thanks to this technology, which has the greatest level of sensitivity in the world—100,000 times greater than the maximum level of 0.0001% among recorded technologies.
Image Credit: Billion Photos/Shutterstock.com
This method combines a primer/probe design that suppresses the fluorescence signal of normal genes and amplifies only the fluorescence signal of cancer mutant genes with nanomaterial technology that substantially boosts the fluorescence signal. This is due to the fact that the exact distinction of small fluorescence signals, in addition to robust fluorescent signal expression technology, is necessary for the reliable detection of even very small levels of cancer mutant genes.
The group created a biochip in the shape of a microarray that can simultaneously identify three different EGFR mutant genes—deletion, insertion, and point mutations. The biochip is based on a plasmonic substrate composed of three-dimensional, extremely dense gold nanostructures.
After assessing the clinical performance of 43 domestic lung cancer patients (stages 1 through 4) and 40 normal groups, a clinical sensitivity of 93% was established for lung cancer patients and 100% for the normal group.
This technology can help with early cancer diagnosis and recurrence identification, and it can also be crucial for monitoring treatment efficacy and creating individualized treatment regimens. Furthermore, a less complicated and less taxing type of assessment for patients is liquid biopsy, which uses blood instead of surgical tissue samples. Additionally, it could be used as a routine screening test, which will ultimately enhance the standard of cancer care and treatment.
Because it is capable of comprehensively detecting various cancer mutations with the world's highest level of ultra-high sensitivity, it can become a leading player in the early cancer diagnosis and treatment/recurrence monitoring market. We expect that this will greatly improve the survival rate and quality of life of cancer patients.
Min-young Lee, Study Senior Researcher, National Research Council of Science and Technology
Journal Reference:
Lee, Y, J., et al. (2024) Highly Sensitive 3D-Nanoplasmonic-Based Epidermal Growth Factor Receptor Mutation Multiplex Assay Chip for Liquid Biopsy. Small Science. doi.org/10.1002/smsc.202400101