EntroGen Receives FDA Approval for CRCdx® RAS Mutation Detection Kit as Companion Diagnostic for Vectibix®

2023-10-04
PRNewswire
诊断试剂
LOS ANGELES, Oct. 3, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted approval for EntroGen's CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted therapy used in the treatment of colorectal cancer. This landmark premarket approval (PMA) marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx® is the first approved real-time PCR-based test in the U.S. that fully meets the biomarker identification requirement for Vectibix®.
The CRCdx® RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.  The kit's high sensitivity and specificity enable clinicians to quickly and easily identify patients most likely to benefit from Vectibix® therapy and avoid unnecessary side effects and costs from treatment.
"We expect CRCdx® to improve access to RAS testing at small and mid-size laboratories by simplifying the testing procedure while improving the turnaround time and lowering the diagnostic costs," said Matthew Minkovsky, CEO of EntroGen. "CRCdx® is available immediately," he added.
About EntroGen:
EntroGen is a leading biotechnology firm offering end-to-end solutions in molecular diagnostics for oncology and hematology by providing automation, reagents, and software. Starting from automated nucleic acid extraction and culminating in genomic interpretation with its proprietary software embedded throughout the entire workflow, EntroGen solutions are designed to be accurate, economical, and scalable.
For more information, please visit www.entrogen.com
About CRCdx® RAS Mutation Detection Kit:
The CRCdx® RAS Mutation Detection Kit is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (CRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a 'no mutation detected' test result in accordance with the approved therapeutic product labeling.
For more information, please visit www.crcdx.com.
Vectibix® is a registered trademark of Amgen, Inc.
CONTACT: Matthew Minkovsky, information@entrogen.com
SOURCE EntroGen
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
机构
适应症
靶点
药物
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。