Shuwen Biotech announced that it has received CE-IVD marking for its EGFR real time PCR detection kit allowing the company to market its kit in countries that recognize the designation.
The CE Marked kit showcases Shuwen’s strengthening research and development capabilities which ultimately have led to a series of increasingly innovative products for the market. The EGFR kit has a limit of mutation detection at 0.1% in a background of wild-type DNA for key mutations. The kit contains lyophilized reagents which withstand at least 12 freeze/thaw cycles, increasing the kit’s stability while lowering logistics costs for clients.
In addition to the EGFR real time PCR detection kit, Shuwen is leveraging its proprietary CODAR-PCR technology on real-time PCR platform to finalize development of a number of other innovative diagnostics such as EGFR-T790M (liquid biopsy), BRAF, ALK, and ROS1 mutation detection assays. Initial tests show that the EGFR-T790M mutation detection assay has a limit of mutation detection at an exceptional 0.01% in a background of wild-type DNA which holds significant value to various clinical and drug development strategies worldwide.
“At Shuwen, we believe innovation is fundamental to leading the market into new frontiers and this is what we primarily focus on,” said Jay Z. Zhang, CEO of Shuwen Biotech. “Through cutting-edge technical innovations we aim to raise the bar with regards to sensitivity, specificity, convenience of use and transport in molecular diagnostic kits.”
About Shuwen Biotech
Led by U.S. and European diagnostic industry veterans, Shuwen Biotech is engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide doctors and their patients with a comprehensive menu of the most innovative products and services for improved disease prediction, screening, diagnosis, prognosis and treatment in the areas of cancer, maternal fetal medicine, acute care, and preventive testing.
Dr. Vafa Amirkia