Human ROS1 Fusion Gene Detection PCR Kit This kit is used to qualitatively detect 15 types ROS1 fusion/rearrangement mutations in exons 32, 34, 35 and 36, and is intended to aid clinicians in identifying patients with non-small cell lung cancer (NSCLC) who may benefit from tyrosine kinase inhibitor (TKI) treatments. The National Comprehensive Cancer Network (NCCN) recommends that the NSCLC patients who are being considered for first- line therapy with ROS1 TKIs should test the ROS1 rearrangement mutations condition. Competitive advantages: • The detection sensitivity of 100 copies can be reached in the context 100 ng wild-type genome RNA. • Innovative and advanced Shuwen CODAR-PCR technology • Short running time within 2 hours • Simple procedure applies to only one step for sample application; any general PCR lab can perform the test and easily standardized • Strict production standard, CE certified approved and reached Good Manufacturing Practice (GMP) and ISO13485 requirements Details: This assay is a Taqman probe based real time fluorescent PCR method detecting 15 types ROS1 rearrangement mutations. Allele specific primers and probes are used for enhancing sensitivity and specificity. The detection sensitivity of 100 copies can be reached in the context 100 ng wild-type genome RNA. 15 Mutations Covered: Rearrangement companion genes Exons of rearrangement companion genes Exon of ROS1 Cosmic ID SLC34A2 Exon4 Exon32 COSF1197 CD74 Exon6 Exon32 COSF1203 SLC34A2 Exon13 Exon32 COSF1260 SDC4 Exon2 Exon32 COSF1266 SDC4 Exon4 Exon32 COSF1279 SLC34A2 Exon4 Exon34 COSF1198 CD74 Exon6 Exon34 COSF1201 SLC34A2 Exon13 Exon34 COSF1261 EZR Exon10 Exon34 COSF1268 SDC4 Exon4 Exon34 COSF1280 GOPC Exon8 Exon35 COSF1251 LRIG3 Exon16 Exon35 COSF1270 TPM3 Exon8 Exon35 COSF1274 GOPC Exon4 Exon36 COSF1295 TPM3 Exon2 Exon36 COSF1664 Compatibility: ABI 7500ABI, Agilent Stratagene MX3000p, cobas®z 480, LightCycler® 480II, Rotor-Gene Q About Shuwen Biotech Based in China and 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. Shuwen Biotech welcomes inquiries from pharmaceutical and diagnostic partners. Please reach us at: [email protected] Domestic Service Hotline: +86 400-697-9623 Headquarters: 333 Changhong Dongjie, Building 3, Deqing, Zhejiang Province China 313200 Web: www.shuwenbiotech.com.