NEW YORK (GenomeWeb News) –Amoy Diagnostics today said that China's State Food and Drug Administration has approved the company's EML4-ALK Fusion Gene Detection Kit for marketing in that country.
The approval allows Amoy to market the kit, which received CE Marking in January, for clinical use.
The assay detects 21 fusion products from rearrangements of the EML4 and ALK genes and uses a two-step process to detect mutations in tumor nucleic acids. It and Amoy's other SFDA-approved and CE-marked assays, including its EGFR, KRAS, BRAF, and PIK3CA mutation detection kits, have been validated on PCR instruments from several manufacturers, the Xiamen, China-based company said.
"Our goal is to provide a comprehensive panel of molecular tests that will quickly and reliably identify driver mutations in cancer tissue so that patients can receive the most appropriate treatment based on the mutation profile of their tumor," David Whyte, VP of global development, said in a statement. "We believe firmly that real-time PCR is the technology of choice for therapeutic target identification, due to its ease of use and high sensitivity."