Genetic Engineering & Biotechnology News

NOV15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | | NOVEMBER 15, 2017 | 21 present in the entire matrix. If molecules are rare, the test can be run longer to achieve the desired confidence values. One can also add more nanopore chips to count more mol- ecules per unit time. Researchers and assay developers have used the 2PG platform to develop rapid tests for pathogens, field-based agricultural targets, proteins (such as antibodies and tox- ins), and even individual elements (such as lead, in water-monitoring applications). Assay developers can adapt reagents from existing diagnostic tests for use on the plat- form, such as the primers that amplify ctDNA in a liquid biopsy test. The only proprietary modification of these reagents is the linking of PEGylated probes that hybridize directly with the specific DNA sequence of interest. (Locked nucleic acids, bridged nucleic acids, and many other probes may be used.) Pilot Study at UCSF Andrew Ko, M.D., professor of clinical medicine at the University of California, San Francisco (UCSF), conducted a pilot study to determine the sensitivity and accuracy of the platform for liquid biopsy. He presented his results at the Cambridge Healthtech In- stitute's 2017 Next Generation Dx Summit. According to Dr. Ko, 2PG's platform de- tected the KRAS G12D point mutation from ctDNA isolated in both blood and urine samples at clinically actionable levels. For this study, samples were taken from nine patients who had colorectal or pancre- atic cancer. The patient's tumors were previ- ously confirmed via DNA sequencing of bi- opsied tissue known to harbor the mutation. Blood samples were provided by all patients, and urine samples were also available from five of the patients. The KRAS G12D mutation was detected in all nine blood samples, and more impor- tantly, in all five urine samples, demonstrat- ing the viability of a small, low-cost system that could eliminate the need for blood draws. Even more significantly, the process directly determined the mutant allele frequency, which may prove to be essential for clinical use in determining therapeutic treatment. Compari- son studies to predicate platform quantitative polymerase chain reaction assays were per- formed, and similar results were obtained. This represents the first time a handheld testing system was used in a clinical liquid biopsy test and demonstrates a key potential use of the platform: enabling low-cost, prac- tical serial monitoring to measure how muta- tion status changes over time. Such a system could vastly improve the data collection nec- essary for FDA approval of new liquid biopsy tests. It could also promote the development of testing solutions that would be both eco- nomically viable and effective in settings be- yond the laboratory, that is, in clinics around the globe and even in people's homes. Broad Applications for Handheld Molecular Detection 2PG provides a platform that is intended to help independent developers create assays that can detect virtually any kind of mole- cule. This is akin to the smartphone model, where a universal device supports third-par- ty products and services for diverse indus- tries. Early adopters of the platform include diagnostic, drug, and agricultural companies looking to expand their existing markets into the point-of-use market by leveraging their IP portfolio of reagents. 2PG's devices may also contribute to the "Internet of things" by wirelessly transmit- ting anonymized data to authorized systems and cloud infrastructures. This kind of func- tionality would ameliorate the "last mile" problem particular to the accumulation and exchange of electronic health records. Es- sentially, the problem is that diagnostic test results are still mostly manually entered by lab operators into legacy systems. Possible future applications for 2PG assays include telemedicine, home testing, clinical tri- als for drug development, and global tracking of pathogens and diseases. Non-human test- ing examples include the monitoring of food processing plants (to detect listeria and other pathogens), farms (to detect crop-destroying viruses), animals (to detect infections), and environmental reservoirs (to detect cholera in rivers or disease vectors in mosquito traps). Monsanto recently announced that it intends to evaluate the technology and develop assays for the detection of certain biomolecules in crops, pests, and pathogens. 2PG's battery-operated device allows for nearly universal global accessibility and can be deployed in many clinical or applied testing situations, even where conditions are challeng- ing, as they often are in remote regions or any- where electrical grids are unreliable. 9 th Annual SUMMIT FOR CLINICAL OPS EXECUTIVES GEN Subscribers Save 15%! 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