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 25 of 47

24 Clinical OMICs November/December 2017 enough risk to receive it. Not only are Color 's tests regularly low priced, but the company also had a foundation "Color for All" that pays for testing in women who cannot afford it. "In 2017, there is no reason a woman with a BRCA mutation should die of breast or ovarian cancer," Hagenkord said. Another thriving arena is the pre-conception and prena- tal testing market, which has swelled, especially as more countries accept these technologies. Sema4 is a spin out of the Icahn School of Medicine at Mount Sinai. The company offers several genomic tests that can be ordered through physician's offices. But it also offers a carrier test (for risk of inherited disease among would-be parents) directly to con- sumers through the firm Helix. That test must be approved by a physician though. The Helix model, similar to others such as 2PG, is one of creating a platform that others can use to offer consumers "value-added" apps. "We are trying to push diagnostics from a testing business to one built around data" explained Eric Schadt, Sema4's CEO. Helix provides a whole exome testing service to con- sumers, but Sema4 adds value to that through their direct-to- consumer carrier test, which currently covers 67 disorders. Sema4 also sells a more extensive carrier test through phy- sicians, and is eyeing the newborn screening market. "Con- sumer initiated clinical testing is ramping up, especially in the recreational areas such as diet, exercise, and ancestry" Schadt said. But he points out that most genomics firms are "vectoring toward the same ideal—a starting place where everyone has comprehensive genomic sequencing." Basil Leaf Technologies is also seeking to tap the consumer market. Although the company isn't doing any omics tests at this time, they represent two crucial trends in the POC mar- ket: the move to put devices in the patients' own hands; and the growing use of artificial intelligence. Basil Leaf's DxtER (continued from page 22) Beating Back the Bugs One potential growth area for point- of-care testing is infectious diseases. While relatively rare and often geo- graphically confined, outbreaks of deadly diseases such as SARS, ebola, and Zika capture the public's atten- tion and spur diagnostic development races. After the Ebola outbreak in 2014, The World Health Organization ( WHO) joined forces with Médecins Sans Frontières (MSF) and the Foun- dation for Innovative New Diagnostics (FIND) to help issue guidelines for the development of rapid point-of-care Ebola diagnostic tests for the disease. According to a WHO report, FIND's Chief Scientific Officer Mark Perkins said the group was "taking the nor- mal process of research and devel- opment along with evaluation and implementation, which takes some- where between two and 10 years and trying to compress this into two to 10 months." Unfortunately, this has proved a difficult challenge so far, although some promising tests are in development. Genomics-based tests to identify pathogens during outbreaks of MRSA in hospitals, rehab centers, and long- term care facilities are also increas- ingly important, especially if such tests are more precise, diagnosing down to the specific bacterial strain. "Genomic testing has the advantage of being able to identify multiple organisms in a single sample, thereby better guid- ing prescribing," said Henry Glorikian, a healthcare and life sciences consul- tant. MRSA causes 5% of infections in US hospitals. These organisms can contaminate medical facilities, leading to extended patient stays, disability, deaths and high expenses. But there are also dozens of com- mon infectious diseases that could be better controlled with more rapid testing. Cepheid has taken a lead in the infectious disease arena with its Xpert Express test. The company recently received clearance for a strep A test that can provide results in less than 20 minutes. They also announced the launch of Xpert MTB/RIF Ultra, for the diagnosis of TB and rifampicin resistance. Among other projects, Cepheid is collaborating with the Bill & Melinda Gates foundation on a POC HIV test. n nopparit / Getty Images

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