Release date: 2016-01-26
Roche, based in Basel, Switzerland, is recognized as a leader in medical research, innovation in the pharmaceutical and diagnostic fields, and is now working on new tools for the diagnosis and treatment of individual lung cancer.
Individualized treatment requires genomic identification of the patient's tumor cells, while DNA testing requires sampling of the tumor, either from a surgical biopsy or from a liquid biopsy. However, patients with critical lung cancer may not be able to undergo a surgical biopsy and may not have enough tumor tissue to sample. Liquid biopsy is a simple, non-invasive surgical biopsy alternative that uses a small amount of cancer DNA in the blood to reveal which treatment is most likely to be effective for the patient.
Genomic instability leads to changes in copy number that mark malignant lesions and can be identified by next-generation massively parallel sequencing. Sudden cancer cells release tumor-specific cell-free DNA (cfDNA) into serum and plasma, and cfDNA is an easily accessible target. Analysis of such liquid biopsy samples is simple and non-invasive, so it is easy to repeat to monitor the genetic changes of each tumor in each lung cancer patient.
Cancer cell genome testing can be performed with a new generation of assay products, such as the recently obtained CE marker for the Roche EGFR Mutation Test v2, which specifically targets non-small cell lung cancer (NSCLC). This allows the clinician to replace the surgical biopsy sample with a readily available blood sample containing tumor-specific cfDNA.
The EGFR mutation test v2 is Roche's first tumor assay product that uses plasma or tumor tissue as a sample. The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene and can also be used to assist in the selection of non-small cell lung cancer patients who are eligible for EGFR tyrosine kinase inhibitor (TKI) therapy. In addition, Roche developed a cfDNA sample preparation kit optimized for extracting DNA from plasma. The EGFR mutation test v2 was designed to run on the cobas 4800 system version 2.1 or higher. The system can also be used to detect mutations in the KRAS and BRAF genes in tumor samples.
Miro Venturi, global director of diagnostic biomarkers at Roche, said: "Liquid biopsy will subvert cancer testing. In terms of patient acceptance and disease diagnosis, rapid and easy to repeat non-invasive testing has obvious advantages. In the longer term, liquid biopsy may It will eventually be used to capture early signs of cancer before symptoms appear. This may fundamentally change the way we understand and treat cancer."
A few liquid biopsy has been approved and marketed in some countries, and more products are under development. This new approach to cancer diagnosis will revolutionize cancer detection and treatment.
Other types of diagnostic test products are also being developed to simultaneously probe multiple biomarkers in tumor tissue or circulating tumor cells to determine if there are multiple genetic defects in the same tumor cell.
Source: LabMedica
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