Clinical OMICS

MAR-APR 2018

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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28 Clinical OMICs March/April 2018 www.clinicalomics.com the U.K. or Canada are likely to struggle with assessing the economic value of personal genome sequencing. "Questions about whether, for who, and for what potential applications or conditions such testing should be paid for by the inevita- bly limited public resources are likely to arise." Big Data Challenges It is predicted that approximately 2 billion human genomes will be sequenced by 2025, which, if true, will be an enor- mous amount of data to process. There is agreement among many scientists that individuals participating in personal genome sequencing should have direct access to, and control of, their genetic data. But that there should be some clinician or genetic counselor involved to help minimize misunder- standing and misinterpretation of the information. "Clear communication with participants is key," empha- sized Gryzmski. "The healthcare system cannot be so pater- nalistic that it dictates everything that is being done with the data, whether or not the participant chooses to have it." The speed of advancement in the field of genetics means that many primary healthcare providers do not know cur- rently know enough about interpreting genomic data to adequately advise their patients on the implications if they choose to have their genomes sequenced. "Getting the information into the care delivery setting and educating the providers of care is the key challenge," said Grzymski. "The information does no good if not inte- grated into care." Regulating the Unknown In 2013, the U.S. Food and Drug Administration stopped 23andMe from selling genetic health risk tests, citing con- cerns about accuracy and potential misinterpretation of results. This ban was lifted last April and in a statement released in November, the agency went one step further and announced that new genetic health risk tests would be "exempted from premarket review under certain con- ditions," essentially making it easier for companies like 23andMe to reach the market. "Given the rapid development of commercially avail- able screening panels, I think we're getting a lot better at approval, speed, and development, although there's work to be done," commented Jacob Sherkow, a specialist in legal issues affecting the bioscience sector at New York Law School. He noted there are many legal problems that could arise from personal genome sequencing including patent infringement, regulatory issues, and liability concerns—for example, a patient choosing to get a preventative mastec- tomy based on a cancer screening test that is later found to be unnecessary. "Companies should strive for both analytic and clinical validity in all the tests they do," he emphasized. "Consum- ers can do a lot to educate themselves too about the reality of these tests, their accuracy, and the risks they run." To address potential privacy concerns surrounding an individual's genomic data, the Genetic Information Nondis- crimination Act (GINA) was introduced in the U.S. in 2008. with similar laws passed in other countries. But GINA has been criticized for not providing protections related to life, long-term care or disability insurance. "It goes some way towards protecting people, but I think there definitely still needs to be a lot more societal conversa- tions about these broader issues," commented Kung. An important consideration for any form of genetic health testing is how useful it is for the person being tested to know about a specific variant, particularly if it increases the risk for a late onset disease with no current treatment. This is something Veritas is working on to incorporate in their testing services. "Even for something that's very late (continued from previous page) By some estimates, approximately 2 billion human genomes will be sequenced by 2025. Veritas Genetics employs the latest sequencing technologies including these NovaSeq 6000 sequencers from Illumina.

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