(Yicai Global) Oct. 10 -- Amoy Diagnostics' companion diagnostic reagents for lung cancer treatment recently got the nod from South Korea's food and drug regulator, granting them access to the country's pharma market.
The Xiamen, Fujian province-based molecular diagnostics company released the above news in a statement yesterday.
The diagnostic kit provides diagnostic reagents for Crizotinib -- a targeted drug used in therapies in the clinical detection of the ROS1 gene fusion state for non-small-cell lung cancer -- to screen patients suitable for treatment with Crizotinib, per the statement.
This reagent features high sensitivity, good specificity, user-friendly control and application to a wide range of sample types. It also provides a scientific basis for the clinical treatment of lung cancer.
It has successively registered with China's State Drug Administration, gained the EU's CE [conformite europeenne] certification and won approval from Japan's Ministry of Health, Labor and Welfare for inclusion in Japan's medical insurance scheme, per the statement.
Crizotinib, developed by US Pfizer, is used for targeted cancer therapies; its trade name is Xalkori, public data show.
Editor: Ben Armour