Clinical OMICS

MAY-JUN 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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18 Clinical OMICs May/June 2018 www.clinicalomics.com Diagnostics growing at the rate of genetic counsel- ors," Ramos said. "While I certainly recognize that there are sometimes big issues around access to genetic coun- selors, I think the idea of there being a shortage is really a little bit of a chal- lenging piece of terminology." Ramos said physicians and patients can find genetic counselors through NSGC's "Find a Genetic Counselor" online directory. "People should have a good understanding that DTC test- ing may be a starting point. But really, they should be engaging with experts like genetic counselors to really understand what their results mean, and how that might fit into their healthcare." 'Thousands of Samples' The largest DTC testing company, 23andMe, said in a prepared response that the study was not specifically based on its data, "and has nothing to do with the information 23andMe interprets and reports to consumers. "The study's small sample size of 49 is not enough data to support its con- clusion. In contrast, 23andMe accu- racy tests are performed on thousands of samples," the company noted. 23andMe also added that it is the only DTC company to gain FDA authorizations for its tests, showing them to be > 99.9% accurate. The FDA in March granted 23andMe the agen- cy's first authorization for a DTC can- (continued from previous page) Almac Validates Illumina Cancer Mutation Panel for Prospective Testing in Clinical Trials Almac Diagnostics announced it has analytically validated Illumi- na's TruSight Tumor 170 cancer mutation panel as an investiga- tional use only assay for prospective testing in clinical trials. Al- mac Diagnostics was one of only a handful of labs globally to be granted beta test site status for the panel prior to its commercial release in 2016, which has allowed the labs at Almac to build sig- nificant experience with the cancer panel. The Almac Illumina TruSight Tumor 170 Clinical Trial Assay is a next-generation sequencing (NGS) assay for use with FFPE tis- sue from solid tumours that targets DNA and RNA variants from the same sample. The Almac assay covers common cancer genes including key actionable mutations across multiple cancers. It targets single nucleotide variants, indels, and gene fusions. The clinical trial assay does not cover amplifications or splice variants, but these can be identified in the RUO version of the assay also offered by Almac Diagnostics. "This Almac Diagnostics clinical trial assay will provide Phar- maceutical and Biotech companies with a new option in the marketplace to support their clinical trials and CDx development. The assay allows multiple biomarkers to be evaluated from one sample, thereby reducing the quantity of precious tissue sample necessary and offering a highly cost effective solution that will ultimately be kit-able further downstream," said Michael Sloan, global vice president of commercial development, Almac in a press release. n National Society of Genetic Counselors President Erica Ramos advocates that individuals who receive results of genetic testing should consult with experts to interpret the results. DrAfter123 / Getty Images

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