Clinical OMICS

MAR-APR 2019

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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44 Clinical OMICs March/April 2019 www.clinicalomics.com W hen the rough draft of the human genome was com- pleted in 2000, President Bill Clinton declared to the world that "Genome science will have a real impact on all our lives …it will revolutionize the diagnosis, prevention and treatment of most, if not all, human diseases." In the 18-and-a-half years since this pronouncement, we've made tremendous progress in genomics. Whereas the first genome took 15 years and $3 billion to complete, we can now sequence a genome in less than a day for under $1000. Yet, I would argue that we are still a long way off from impacting all lives and all diseases. Wide adoption of genomics into the clinic will take more than just technological advancement. Key in my mind are three things that we must stay focused on: actionability, access and education. Actionability Physicians and patients are not interested in data for data's sake. Sequencing only makes sense if there's the possibil- ity that something can be done with the data. More and more this is becoming the case, especially when it comes to cancer treatment. There are now more than 40 cancer therapies with com- panion diagnostics in their labels. We've seen progress in treatments that target global signatures of genetic disrup- tion such as tumor mutational burden (TMB). There have also been approvals of drugs for use in any tumor with the right genetics, regardless of the tissue of origin. But the current drugs address only a small subset of the hundreds of genetic signatures that have been found to be associated with cancer. The inclusion of biomarkers in drug development and clinical trials is essential. I am heartened at FDA's establishment of the Office of Drug Evaluation Science, which plans to develop standards in this area in collaboration with drug developers, academics and other stakeholders. Access Patients won't benefit from genomic tests unless they can afford them, which for most people means that insurance coverage is critical. Non-invasive prenatal testing (NIPT) for all pregnancies is an example where coverage has lagged, keeping women whose pregnancies are not deemed high-risk from access- By Francis daSouza, CEO, Illumina What Does It Take to Drive Genomics into the Clinic? Ca-ssis / iStock / Getty Images

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