(Yicai Global) June 29 -- China’s Amoy Diagnostics announced today that Japanese regulators have approved its self-developed multi-gene combined lung cancer detection kit for sale in the country.

AmoyDx Pan Lung Cancer PCR Panel, which is based on the firm’s polymerase chain reaction platform, was given the marketing green light by Japan’s Pharmaceuticals and Medical Device Agency, Amoy Diagnostics said in a statement today.

The product can detect multiple core lung-cancer driving genes, 11 genes in particular, with high sensitivity, good specificity, simple operation, short reporting time and wide range of applicable samples, the Xiamen-based company said.

The kit can help find beneficiaries of targeted therapy quickly and comprehensively in clinical practice, the firm added. It is Amoy Diagnostics’ second companion diagnostic product approved in Japan after ROS1 in 2017.

The occurrence of lung cancer is closely related to the driver genes, and different types of lung cancers are driven by different genes. So appropriate drugs can be used for treatment based on different driver genes.

The PMDA’s approval of the kit also signifies Amoy Diagnostics’ strong position in the Japanese companion diagnostics market, which will further enhance its competitiveness in overseas markets and have a positive impact on the company’s future development, it added.

Sales in Japan will depend on the effectiveness of marketing, and it is not possible to predict the impact on future earnings performance, the firm said.

Shares of Amoy Diagnostics [SHE: 300685] closed down 2 percent today at CNY104.08 (USD16.11) in line with the overall Shenzhen market, which fell 1 percent.

Editor: Peter Thomas