“Our one-step nucleic-acid amplification technology provides a rapid intraoperative method for assessing metastasis in breast cancer patients,” said Vishal Sikri, marketing manager for life sciences at Sysmex America.
During cancer surgery lymph nodes may be sampled and metastases diagnosed through classical intraoperative methods (frozen section and imprint cytology). However, these types of intraoperative procedures may have a false-negative rate as high as 52%, based on peer-reviewed studies. In studies from Europe and Japan, a one-step nucleic-acid amplification technology has been applied in which multiple mRNA markers are measured.
The amplification step, known as RT-LAMP (loop-mediated isothermal amplification), is an isothermic nucleic-acid amplification technology that is thoroughly documented in the peer-reviewed literature. It can yield results in as little as 30 to 40 minutes, making it suitable for use in cancer surgery. Because it allows for a semiquantitative estimate of cancer-related genes, it is less subjective than the traditional methods of deciding degrees of malignancy.
Some of these markers, such as CK19 (cytokeratin 19), were greatly overexpressed in malignant lymph nodes, so much so that there was no overlap with the profiles of normal lymph nodes.
“The technology has been in clinical use in Europe for 2–3 years and in Japan for the last year,” Sikri stated. “It is currently not available for clinical use in the U.S.”
Rapid advances in clinical diagnostics are adding to a large portfolio of molecular applications. Faster, easier, and more accurate than technologies in place for years, the new face of clinical medicine promises to be cheaper and more user friendly.
Some, such as the serum-based assessment of allergic reactions, are safer and more accurate, whereas others, in the LAMP technology, are much faster and more accurate.
At a time when a noisy debate is in progress on the astronomical cost of healthcare, the new face of clinical medicine will provide better, more efficient healthcare at a more manageable price.