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FOR IMMEDIATE RELEASE<\/p>\n
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Apr 28, 2025<\/strong> – Los Angeles<\/strong> \u2014 EntroGen Inc., a leader in molecular diagnostics, announced today that its CRCdx\u00ae RAS Mutation Detection Kit has received national coverage from the US Centers for Medicare & Medicaid Services (CMS). This milestone significantly enhances access to precision oncology for Medicare beneficiaries diagnosed with colorectal cancer, enabling broader adoption of CRCdx\u00ae nationwide.<\/p>\n <\/p>\n <\/p>\n The CRCdx\u00ae RAS Mutation Detection Kit is the first FDA-approved real-time PCR-based companion diagnostic for identifying patients eligible for treatment with Vectibix\u00ae (panitumumab), based on the absence of KRAS and NRAS mutations. Now with CMS coverage, laboratories and healthcare providers can confidently integrate CRCdx\u00ae into clinical workflows without the barrier of out-of-pocket patient costs, accelerating the adoption of personalized cancer care.<\/p>\n <\/p>\n <\/p>\n “CMS reimbursement for CRCdx\u00ae represents more than just a policy decision\u2014it\u2019s a validation of the test\u2019s clinical value and impact,” said Matthew Minkovsky, CEO of EntroGen. “With CMS reimbursement, we expect CRCdx\u00ae to reach even more laboratories and patients. This reinforces our commitment to making precision medicine accessible and affordable.”<\/p>\n <\/p>\n <\/p>\n The decision by CMS reflects the critical role of biomarker-driven treatment strategies in improving outcomes for colorectal cancer patients. CRCdx\u00ae\u2019s streamlined workflow, rapid turnaround time, and robust performance characteristics make it a practical and scalable solution for identifying patients likely to benefit from anti-EGFR therapy. CRCdx\u00ae is available for immediate<\/p>\n <\/p>\n <\/p>\n About EntroGen:<\/strong><\/p>\n <\/p>\n <\/p>\n 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.<\/p>\n <\/p>\n <\/p>\n For more information, please visit www.entrogen.com<\/a><\/p>\n <\/p>\n <\/p>\n About CRCdx\u00ae RAS Mutation Detection Kit:<\/strong><\/p>\n <\/p>\n <\/p>\n The CRCdx\u00ae 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 tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer patients who may benefit from treatment with Vectibix\u00ae (panitumumab) based on a “no mutation detected” test result, in accordance with the approved therapeutic product labeling.<\/p>\n <\/p>\n <\/p>\n For more information, please visit www.crcdx.com<\/a>.<\/p>\n <\/p>\n <\/p>\n Vectibix\u00ae is a registered trademark of Amgen, Inc.<\/p>\n <\/p>\n <\/p>\n ###<\/p>\n <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]","protected":false},"excerpt":{"rendered":" Apr 28, 2025 \u2013 EntroGen announced today that its CRCdx\u00ae RAS Mutation Detection Kit has received national coverage from the US Centers for Medicare & Medicaid Services (CMS).<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"\n FOR IMMEDIATE RELEASE<\/p>\n\n\n\n Apr 28, 2025<\/strong> - Los Angeles<\/strong> \u2014 EntroGen Inc., a leader in molecular diagnostics, announced today that its CRCdx\u00ae RAS Mutation Detection Kit has received national coverage from the US Centers for Medicare & Medicaid Services (CMS). This milestone significantly enhances access to precision oncology for Medicare beneficiaries diagnosed with colorectal cancer, enabling broader adoption of CRCdx\u00ae nationwide.<\/p>\n\n\n\n The CRCdx\u00ae RAS Mutation Detection Kit is the first FDA-approved real-time PCR-based companion diagnostic for identifying patients eligible for treatment with Vectibix\u00ae (panitumumab), based on the absence of KRAS and NRAS mutations. Now with CMS coverage, laboratories and healthcare providers can confidently integrate CRCdx\u00ae into clinical workflows without the barrier of out-of-pocket patient costs, accelerating the adoption of personalized cancer care.<\/p>\n\n\n\n \"CMS reimbursement for CRCdx\u00ae represents more than just a policy decision\u2014it\u2019s a validation of the test\u2019s clinical value and impact,\" said Matthew Minkovsky, CEO of EntroGen. \"With CMS reimbursement, we expect CRCdx\u00ae to reach even more laboratories and patients. This reinforces our commitment to making precision medicine accessible and affordable.\"<\/p>\n\n\n\n The decision by CMS reflects the critical role of biomarker-driven treatment strategies in improving outcomes for colorectal cancer patients. CRCdx\u00ae\u2019s streamlined workflow, rapid turnaround time, and robust performance characteristics make it a practical and scalable solution for identifying patients likely to benefit from anti-EGFR therapy. CRCdx\u00ae is available for immediate<\/p>\n\n\n\n About EntroGen:<\/strong><\/p>\n\n\n\n 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. <\/p>\n\n\n\n