develop companion diagnostics. Thermo Fisher Scientific on September 25 announced a partnership with GlaxoSmithKline and Pfizer to develop an NGS oncology test for solid tumors. The test will be used as a companion diagnostic for several drug programs after premarket approval from the FDA and other regulatory agencies. The test will apply to CNVs, gene fusions, indels and single-nucleotide variants over 143 genes. Of those genes, 26 are targets of available oncology drugs, and 44 are used in criteria for clinical trials. The test will be developed using the Ion PGM Dx System, which was approved by the FDA for clinical use as a class II medical device on September 18. The System can be used for targeted genome sequencing of human DNA from peripheral whole blood. It allows users to develop and implement new molecular-diagnostic assays of their own specifications for use in clinical laboratories and allows 21 CFR Part 11 compliance.

Also affecting the clinical NGS market is standard development, as discussed in another recent IBO article (see IBO 9/15/14). A new group, the Actionable Genome Consortium (AGC), founded by Illumina and multiple cancer institutes, was announced early this month for NGS standards development. The AGC aims to define the genomic characteristics of tumors from patients, developing and publishing recommendations for standardizing “actionable events.” This includes obtaining, storing, transporting and extracting biopsy samples; technical standards for sequencing of DNA; standards for calling of variants, annotation and interpretation of sequences; and the content and format of clinical reports. The group plans for its work to be used to develop IVDs, as well as support overseeing regulatory genomic testing for cancer and reimbursement for tests.