Skip to main content
Premium Trial:

Request an Annual Quote

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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.