AL
In 2015, Biodesix (Boulder, Col.) commercialized the GeneStrat liquid biopsy test for monitoring patients with non-small cell lung cancer for driver mutations in the EGFR, KRAS and BRAF oncogenes. Cancer diagnosis can be made within 72 hours of drawing a sample.
The clinical utility of using NGS to uncover genome-wide data combined with a practical reflex assay such as ddPCR to monitor spe- cific biomarkers depends on the ability to find clinically actionable events. Hanlee P. Ji, Ph.D., assistant professor of Medicine at the Stanford School of Medicine, said, “Our research group is very focused on trying to find genetic de- terminants that are indicators of metastatic recurrence…. And that’s very practical because that leads to potential risk assessment for indi- viduals who are more likely to have metastatic recurrent disease, and thus you’d be more likely to treat them aggressively up front [even] if they are lower stage disease.”
Sequencing information obtained from NGS permits researchers to identify possible genomic indicators not only for metastatic recurrence, but also tumor aggressiveness and other central properties of the disease. Once genetic biomarkers are defined, a simplified, more cost-effective ddPCR assay can be devel- oped to enable faster decisions in diagnosis and treatment.
References 1. Bettegowda, C.; Sausen, M. et al. Detection of circulating tumor DNA in early- and late- stage human malignancies. Sci. Transl. Med. 2014, 6(224), 224ra24.
2. Chang, G.A.; Tadepalli, J.S. et al. Sensitivity of plasma BRAFmutant
and NRASmutant cell-free
DNA assays to detect metastatic melanoma in patients with low RECIST scores and non- RECIST disease progression. Molec. Oncol. 2015, 10(1),157–65.
3. Naidoo, J.; Drilon, A. KRAS-mutant lung cancers in the era of targeted therapy. Advances in Experimental Medicine and Biol- ogy 2016, 155–78.
4. Garcia-Murillas, I.; Schiavon, G. et al. Muta- tion tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci. Transl. Med. 2015, 7(302), 302ra133.
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5. Siravegna, G.; Mussolin, B. et al. Clonal evolution and resistance to EGFR blockade in the blood and colorectal cancer patients. Nature Med. 2015, 21, 795–801.
6. Olsson, E.; Winter, C. et al. Serial monitoring of circulating tumor DNA in patients with primary breast cancer for detection of occult metastatic disease. EMBO Molec. Med. 2015, 7(12), 1034–47.
7. Reinert, T.; Schøler, L.V. et al. Analysis of circulating tumour DNA to monitor disease burden fol- lowing colorectal cancer surgery. Gut 2015, 0:1–10. doi: 10.1136/gutjnl-2014-308859.
George Karlin-Neumann, Ph.D., is director of scientific affairs at Bio-Rad Laboratories, Digital Biology Center, 5731 W. Las Positas Blvd., Pleasanton, Calif. 94588, U.S.A.; tel.: 925-474-9072; e-mail: GeorgeKN@bio-rad. com;
www.bio-rad.com
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