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AmoyDx Lung Cancer CDx Approved in South Korea

NEW YORK (GenomeWeb) — Chinese diagnostics firm AmoyDx announced this month that South Korea's Ministry of Food and Drug Safety has approved its ROS1 fusion assay as a companion diagnostic for Pfizer's non-small cell lung cancer (NSCLC) drug Xalkori (crizotinib).

Xalkori inhibits the oncogenes ROS1 and ALK. AmoyDx's PCR-based assay identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids, providing results in around 2.5 hours. AmoyDx noted that ROS1 gene rearrangements occur in about 2.4 percent of Asian NSCLC patients.

The assay received CE marking in 2013. It was approved by China's Food and Drug Administration in 2014 and in Japan in 2017.

The Scan

Ancient Greek Army Ancestry Highlights Mercenary Role in Historical Migrations

By profiling genomic patterns in 5th century samples from in and around Himera, researchers saw diverse ancestry in Greek army representatives in the region, as they report in PNAS.

Estonian Biobank Team Digs into Results Return Strategies, Experiences

Researchers in the European Journal of Human Genetics outline a procedure developed for individual return of results for the population biobank, along with participant experiences conveyed in survey data.

Rare Recessive Disease Insights Found in Individual Genomes

Researchers predict in Genome Medicine cross-population deletions and autosomal recessive disease impacts by analyzing recurrent nonallelic homologous recombination-related deletions.

Genetic Tests Lead to Potential Prognostic Variants in Dutch Children With Dilated Cardiomyopathy

Researchers in Circulation: Genomic and Precision Medicine found that the presence of pathogenic or likely pathogenic variants was linked to increased risk of death and poorer outcomes in children with pediatric dilated cardiomyopathy.