The U.S. Food and Drug Administration has granted approval for EntroGen’s CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix®, a targeted therapy used in the treatment of colorectal cancer.
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
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SOURCE EntroGen
