Clinical OMICS

NOV-DEC 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 22 of 47 November/December 2017 Clinical OMICs 21 tests targeting infectious diseases and cancer. "One of the biggest developments has been a continued push for decentralization of healthcare," said Harry Glo- rikian, healthcare and life sciences consultant as well as the author of Commercializing Novel IVDs: A Comprehensive Manual for Success. "That trend has had a dramatic impact on the diagnostics field overall, and POC in particular." The key challenge is designing tests that can be accurate in virtually anyone's hands, sometimes including those of the patients themselves. And new technologies are allowing the development of more and more such devices. The Platform Approach POC testing is already being offered in a range of settings besides hospitals and doctors' offices, including retail clinics, nursing homes, and urgent care facilities. Nurse practitioners and physician's assistants are more often administering these tests. And while there is relatively lit- tle home testing yet, significant investments are now being made in developing these products as well. 2PG's testing system is usable for POC or home testing. "The device is capable of detecting any molecule," says CEO Dan Heller. That includes proteins, DNA, and RNA. It can also be used for multiplex analyses. The technology is based on a novel nanopore approach using silicon chips, some proprietary biochemistry, and standard reagents. The silicon nanopore sensor is digital and measures an electrical current. The signal is quantified to provide a test result and those data are wirelessly transmitted to authorized IT sys- tems, including on the cloud. "Our business model is not to make any of the tests our- selves," explained Heller. "We are like the iPhone, we cre- ated the platform and it is up to others to write the apps." Companies with established diagnostic tests can make them available on the 2PG platform by going through the FDA approval process. If a company's diagnostic tests are already commercialized, getting them approved on the 2PG platform is simpler. Heller describes the technology as "point-of-care liquid biopsy." "We expect to have developer kits available to third parties in 2018." The company already has multiple research partners, but most of the company's collaborators haven't been announced. Monsanto is 2PG's first publically announced collaborator. The agricultural giant is testing the system for detecting biomolecules in crops pests, and pathogens. In one recent study, 2PG confirmed the MoM sensor detected cell-free, circulating tumor DNA from blood and urine samples of patients with colorectal or pancreatic cancer. The patients' tumors were previously confirmed as having the KRAS G12D point mutation, based on DNA sequencing of biopsied tissue. MoM detected the mutation (continued on next page) chombosan / Getty Images

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