Singapore: Amoy Diagnostics' EML4-ALK Fusion Gene Detection Kit has received market approval from China's State Food and Drug Administration (SFDA). The SFDA regulates drugs and in vitro diagnostics in mainland China. The approval allows AmoyDx to market the EML4-ALK Fusion Detection test for clinical use in China.

The assay detects 21 different fusion products from rearrangements of the EML4 and ALK genes. RNA that has been purified from the FFPE tissue is first reverse transcribed to cDNA with RT enzyme supplied with the kit. The EML4-ALK fusion cDNAs are then specifically amplified with cross-junction PCR primers and qualitatively detected with fluorescent probes. The method has excellent sensitivity and accuracy, and has been validated on PCR instruments from several manufacturers. The test kits are assembled in AmoyDx's ISO13485-certified, GMP-compliant manufacturing plant.

The EML4-ALK fusion oncogene represents one of the newest molecular targets in non-small-cell lung cancer (NSCLC). First described in 2007, the fusion results from a small inversion within chromosome 2p. This inversion leads to expression of a chimeric tyrosine kinase having the N-terminal portions of echinoderm microtubule-associated protein-like 4 (EML4) fused to the intracellular kinase domain of anaplastic lymphoma kinase (ALK). The EML4-ALK protein possesses potent oncogenic activity both in vitro and in vivo. This activity can be blocked by small-molecule inhibitors such as Pfizer's Xalkori.

Amoy Diagnostics announced CE marking for the EML4-ALK Fusion Detection kit earlier, in January of 2013.

Amoy Diagnostics is the major provider of EGFR mutation detection kits in China. The kits are used to identify non-small cell lung cancer patients who will benefit from treatment with anti-EGFR drugs such as Iressa or Tarceva. The company works closely with AstraZeneca in China to promote molecular testing of lung cancer samples so that patients receive the most appropriate treatment option.