{"id":4233,"date":"2025-03-19T18:30:51","date_gmt":"2025-03-19T18:30:51","guid":{"rendered":"https:\/\/entrogen.com\/web4\/?post_type=product&p=4233"},"modified":"2025-10-09T21:54:44","modified_gmt":"2025-10-09T21:54:44","slug":"crcdx-ras-mutation-detection-kit","status":"publish","type":"product","link":"https:\/\/entrogen.com\/web4\/product\/crcdx-ras-mutation-detection-kit\/","title":{"rendered":"CRCdx\u00ae RAS Mutation Detection Kit"},"content":{"rendered":"[et_pb_section fb_built=”1″ admin_label=”Section” _builder_version=”4.27.2″ _module_preset=”default” custom_padding=”6px||4px|||” collapsed=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” width=”100%” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_wc_breadcrumb admin_label=”Woo Breadcrumbs” _builder_version=”4.16″ global_colors_info=”{}”][\/et_pb_wc_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ specialty=”on” _builder_version=”4.27.2″ _module_preset=”default” custom_padding=”0px||9px|||” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_wc_images _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”|||-98px||” custom_padding=”|||23px||” global_colors_info=”{}”][\/et_pb_wc_images][\/et_pb_column][et_pb_column type=”2_3″ specialty_columns=”2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_row_inner column_structure=”1_2,1_2″ _builder_version=”4.27.2″ _module_preset=”default” custom_padding=”|0px||||” global_colors_info=”{}”][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”2_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_wc_title _builder_version=”4.27.2″ _module_preset=”default” header_font_size=”27px” custom_margin=”|-164px||||” global_colors_info=”{}”][\/et_pb_wc_title][\/et_pb_column_inner][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”2_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column_inner saved_specialty_column_type=”2_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_wc_description admin_label=”Woo Product Short Description” _builder_version=”4.27.4″ custom_margin=”-8px|||||” global_colors_info=”{}”][\/et_pb_wc_description][et_pb_wc_meta show_sku=”off” admin_label=”Woo Product Meta” _builder_version=”4.27.2″ global_colors_info=”{}”][\/et_pb_wc_meta][et_pb_button button_url=”https:\/\/entrogen.com\/web4\/product-information-request-form\/” button_text=”Request More Information” button_alignment=”left” admin_label=”Button” _builder_version=”4.27.4″ _module_preset=”default” custom_button=”on” button_text_size=”13px” button_text_color=”#FFFFFF” button_bg_color=”#476e8d” button_border_color=”RGBA(255,255,255,0)” background_layout=”dark” custom_margin=”30px|||||” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” width=”100%” custom_padding=”6px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_tabs admin_label=”Tabs” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”24px|||||” custom_padding=”|30px|60px|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_tab title=”Product Overview” _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]\n

CRCdx\u00ae RAS Mutation Detection Kit is a real-time PCR in vitro diagnostic test designed to detect 35 variants of KRAS and NRAS exon 2, 3, and 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. As a companion diagnostic (CDx), it helps identify CRC patients who may benefit from anti-EGFR therapy, specifically Vectibix\u00ae (panitumumab), by confirming the absence of RAS mutations. This targeted approach ensures that only patients with wild-type RAS genes receive treatment, aligning with approved therapeutic guidelines and improving patient outcomes.<\/p>\n

CRCdx\u00ae is designed with high sensitivity and specificity to accurately detect KRAS and NRAS mutations, even in samples with low tumor DNA content. By utilizing allele-specific oligonucleotide primers and fluorescent hydrolysis probes, the assay can precisely differentiate between wildtype and mutated alleles, minimizing false positives and false negatives. This high level of accuracy ensures that clinicians receive reliable results, enabling them to make well-informed treatment decisions.<\/p>\n

CRCdx\u00ae identifies the presence of the mutations in a total of 8 reactions (groups) per sample. The test does not distinguish between mutations within each group.<\/p>\n

Below is a list of mutations detected by this kit.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Gene<\/strong><\/td>\nExon<\/strong><\/td>\nAA Change<\/strong><\/td>\nNucleotide Change<\/strong><\/td>\nCosmic ID (COSV)<\/strong><\/td>\nPrevalence Percent1<\/sup><\/strong><\/td>\nReaction Mix<\/strong><\/td>\n<\/tr>\n
KRAS<\/td>\n2<\/td>\nG12A<\/td>\nc.35G>C<\/td>\n55497479<\/td>\n1.92, 1.93<\/td>\n1<\/td>\n<\/tr>\n
G12D<\/td>\nc.35G>A<\/td>\n55497369<\/td>\n13.3, 12.83<\/td>\n<\/tr>\n
G12R<\/td>\nc.34G>C<\/td>\n55497582<\/td>\n0.42, 0.4<\/td>\n<\/tr>\n
G12V<\/td>\nc.35G>T<\/td>\n55497419<\/td>\n10.24, 8.92<\/td>\n<\/tr>\n
G13D<\/td>\nc.38G>A<\/td>\n55497388<\/td>\n7.71, 7.33<\/td>\n<\/tr>\n
G12C<\/td>\nc.34G>T<\/td>\n55497469<\/td>\n4.06, 3.22<\/td>\n2<\/td>\n<\/tr>\n
G12S<\/td>\nc.34G>A<\/td>\n55497461<\/td>\n1.65, 1.67<\/td>\n<\/tr>\n
3<\/td>\nQ61H<\/td>\nc.183A>T<\/td>\n55499223<\/td>\n1.26, 0.95<\/td>\n3<\/td>\n<\/tr>\n
Q61H<\/td>\nc.183A>C<\/td>\n55498802<\/td>\n1.26, 0.95<\/td>\n<\/tr>\n
Q61L<\/td>\nc.182A>T<\/td>\n55504296<\/td>\n0.35, 0.35<\/td>\n<\/tr>\n
Q61R<\/td>\nc.182A>G<\/td>\n55498739<\/td>\n0.3, 0.3<\/td>\n<\/tr>\n
A59E<\/td>\nc.176C>A<\/td>\n55568979<\/td>\nNo data<\/td>\n<\/tr>\n
A59G<\/td>\nc.176C>G<\/td>\n55604554<\/td>\nNo data<\/td>\n<\/tr>\n
A59T<\/td>\nc.175G>A<\/td>\n55499283<\/td>\nNo data<\/td>\n<\/tr>\n
4<\/td>\nK117N(AAC)<\/td>\nc.351A>C<\/td>\n55545304<\/td>\n0.45, 0.46<\/td>\n4<\/td>\n<\/tr>\n
K117N(AAT)<\/td>\nc.351A>T<\/td>\n55504752<\/td>\n0.45, 0.46<\/td>\n<\/tr>\n
K117R<\/td>\nc.350A>G<\/td>\n55937655<\/td>\nNo data<\/td>\n<\/tr>\n
K117E<\/td>\nc.349A>G<\/td>\n55716212<\/td>\nNo data<\/td>\n<\/tr>\n
A146T<\/td>\nc.436G>A<\/td>\n55501778<\/td>\n2.06, 2.57<\/td>\n5<\/td>\n<\/tr>\n
A146P<\/td>\nc.436G>C<\/td>\n55541748<\/td>\n0.09, 0.09<\/td>\n<\/tr>\n
A146V<\/td>\nc.437C>T<\/td>\n55498939<\/td>\n0.59, 0.58<\/td>\n<\/tr>\n
NRAS<\/td>\n2<\/td>\nG12D<\/td>\nc.35G>A<\/td>\n54736383<\/td>\n0.8, 0.79<\/td>\n6<\/td>\n<\/tr>\n
G12C<\/td>\nc.34G>T<\/td>\n54736487<\/td>\n0.21, 0.21<\/td>\n<\/tr>\n
G12S<\/td>\nc.34G>A<\/td>\n54736621<\/td>\nNo data<\/td>\n<\/tr>\n
G13R<\/td>\nc.37G>C<\/td>\n54736550<\/td>\n0.27, 0.27<\/td>\n<\/tr>\n
G13V<\/td>\nc.38G>T<\/td>\n54736480<\/td>\nNo data<\/td>\n<\/tr>\n
4<\/td>\nK117R<\/td>\nc.350A>G<\/td>\n104682079<\/td>\nNo data<\/td>\n<\/tr>\n
3<\/td>\nQ61H (CAC)<\/td>\nc.183A>C<\/td>\n54736320<\/td>\n0.24, 0.24<\/td>\n7<\/td>\n<\/tr>\n
Q61H (CAT)<\/td>\nc.183A>T<\/td>\n54736991<\/td>\n0.24, 0.24<\/td>\n<\/tr>\n
Q61L<\/td>\nc.182A>T<\/td>\n54736624<\/td>\n0.32, 0.32<\/td>\n<\/tr>\n
Q61K<\/td>\nc.181C>A<\/td>\n54736310<\/td>\n0.86, 0.87<\/td>\n<\/tr>\n
Q61R<\/td>\nc.182A>G<\/td>\n54736340<\/td>\n0.6, 0.68<\/td>\n<\/tr>\n
3 and 4<\/td>\nA146T<\/td>\nc.436G>A<\/td>\n65731978<\/td>\nNo data<\/td>\n8<\/td>\n<\/tr>\n
A59D<\/td>\nc.176C>A<\/td>\n54738004<\/td>\nNo data<\/td>\n<\/tr>\n
A59T<\/td>\nc.175G>A<\/td>\n54743124<\/td>\nNo data<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/sup><\/p>\n

1<\/sup> My Cancer Genome; www.mycancergenome.org (Colorectal Carcinoma, Colorectal Adenocarcinoma)<\/p>\n

<\/h4>\n

Concordance Test<\/h4>\n

The safety and effectiveness of the CRCdx\u00ae RAS Mutation Detection Kit were evaluated in an external concordance study to demonstrate non-inferiority to the FDA-approved Praxis\u00ae Extended RAS Panel for validating its use as a companion diagnostic for panitumumab (Vectibix\u00ae). The study tested 398 archived CRC patient FFPE tissue samples with both CRCdx\u00ae and Praxis\u00ae, assessing mutation-level agreement. Concordance analysis showed PPA = 99.6%, NPA = 92%, and OPA = 96.2%, confirming CRCdx\u00ae as a reliable alternative for identifying RAS mutation status to guide Vectibix\u00ae treatment decisions.<\/p>\n\n\n\n\n\n\n\n\n
<\/td>\nPraxis\u00ae<\/strong><\/td>\n\n

PPA<\/strong><\/h2>\n<\/td>\n

\n

NPA<\/strong><\/h2>\n<\/td>\n

\n

OPA<\/strong><\/h2>\n<\/td>\n<\/tr>\n

Mutant<\/strong><\/td>\nWT<\/strong><\/td>\nTotal<\/strong><\/td>\n<\/tr>\n
CRCdx\u00ae<\/strong><\/td>\nMutant<\/strong><\/td>\n223<\/td>\n14<\/td>\n237<\/td>\n\n

99.6%<\/h2>\n<\/td>\n

\n

92.0%<\/h2>\n<\/td>\n

\n

96.2%<\/h2>\n<\/td>\n<\/tr>\n

WT<\/strong><\/td>\n1<\/td>\n160<\/td>\n161<\/td>\n<\/tr>\n
Total<\/strong><\/td>\n224<\/td>\n174<\/td>\n398<\/td>\n<\/tr>\n
95% CI<\/strong><\/td>\n97.5% to 100.0%<\/td>\n86.8% to 95.5%<\/td>\n93.9% to 97.9%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/h4>\n

<\/h4>\n

Precision Test<\/h4>\n

The Precision of the CRCdx\u00ae RAS Mutation Detection Kit was evaluated using 16 mutant CRC FFPE specimens, 7 mutant cell lines, and 12 synthetic mutant gene blocks, all diluted to 1.5X or 3X LoD and tested across three device lots at three external sites by two operators per site. Samples were extracted using Promega\u2019s Maxwell\u00ae CSC FFPE DNA Extraction Kit, diluted in wildtype CRC FFPE DNA, and analyzed via NGS. Controls were included in each run, with data analyzed by EntroGen using EPAS\u2122. The study achieved a 90.0% first-pass rate (1,166\/1,296), with 9.3% of samples requiring re-runs due to control failures or user errors. A total of 2,571 (2499\/2499 mutant and 72\/72 wildtype samples) sample replicates were analyzed, achieving a 100.0% correct call rate across all variables.<\/p>\n

 <\/p>\n\n\n\n
\"\"<\/td>\n\"\"<\/td>\n\"\"<\/td>\n\n

\"\"<\/h3>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\nCorrect Mutant Call\/Total Mutant Samples<\/strong><\/td>\n<\/tr>\n
CRCdx\u00ae Reaction<\/strong><\/td>\nSite 1<\/strong><\/td>\nSite 2<\/strong><\/td>\nSite 3<\/strong><\/td>\nCombined<\/strong><\/td>\n<\/tr>\n
1<\/td>\n118\/118<\/td>\n120\/120<\/td>\n120\/120<\/td>\n358\/358<\/td>\n<\/tr>\n
2<\/td>\n47\/47<\/td>\n48\/48<\/td>\n48\/48<\/td>\n143\/143<\/td>\n<\/tr>\n
3<\/td>\n162\/162<\/td>\n168\/168<\/td>\n168\/168<\/td>\n498\/498<\/td>\n<\/tr>\n
4<\/td>\n95\/95<\/td>\n96\/96<\/td>\n96\/96<\/td>\n287\/287<\/td>\n<\/tr>\n
5<\/td>\n72\/72<\/td>\n71\/71<\/td>\n68\/68<\/td>\n211\/211<\/td>\n<\/tr>\n
6<\/td>\n144\/144<\/td>\n144\/144<\/td>\n144\/144<\/td>\n432\/432<\/td>\n<\/tr>\n
7<\/td>\n120\/120<\/td>\n120\/120<\/td>\n120\/120<\/td>\n360\/360<\/td>\n<\/tr>\n
8<\/td>\n68\/68<\/td>\n70\/70<\/td>\n72\/72<\/td>\n210\/210<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

For More Information<\/span><\/a><\/p>\n[\/et_pb_tab][et_pb_tab title=”Workflow” _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]\n

Utilizing the QuantStudio\u2122 Dx real-time PCR instrument (QSDx) and EntroGen\u02bcs PCR Analysis Software (EPAS\u2122), the CRCdx\u00ae assay provides highly accurate and reproducible results. The test employs allele-specific oligonucleotide primers, fluorescent hydrolysis probes, and a hot-start DNA polymerase to amplify KRAS and NRAS gene regions, while an internal control ensures DNA integrity and test validity.<\/p>\n

This test can be completed in approximately 2 hours from isolation of DNA to test result. FFPE tumor samples must contain at least 20% tumor content, a requirement verified by pathology professionals before testing.<\/p>\n\n\n\n
\n

Included in the Kit<\/strong>
\u2022 (8) vials of primer\/probe mix designed to detect distinct groups of mutations
\u2022 (5) vials of reaction mix (enzyme)
\u2022 (1) vial of positive control mix<\/p>\n

 <\/p>\n<\/td>\n

Equipment and Materials<\/strong>
\u2022 Promega Maxwell\u00ae CSC
\u2022 Promega Maxwell\u00ae CSC DNA FFPE Kit
\u2022 ThermoFisher Scientific QuantStudio\u00ae Dx real-time PCR instrument
\u2022 Nuclease free water for the No Template Control (NTC) or negative control<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The kit allows for 40 specimens to be tested.<\/p>\n

\"\"\"\"\"\"\"\"\"\"<\/a><\/p>\n[\/et_pb_tab][et_pb_tab title=”Resources” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]\n

<\/a><\/p>\n\n\n\n\n\n
\"\"<\/a><\/td>\nFDA Approval – CRCdx\u00ae RAS Mutation Detection Kit \u2013 P220005<\/strong><\/a><\/td>\n<\/tr>\n
\"\"<\/a><\/td>\nCetuximab in Treatment of Metastatic Colorectal Cancer: Final Survival Analyses and Extended RAS Data from the NORDIC-VII Study.<\/strong> Guren, Thomsen, Kure, Sorbye, Glimelius, Pfeiffer, \u00d6sterlund, Sigurdsson, Lothe, Dalsgaard, Skovlund, Christoffersen, Tveit. Comparison of KRAS Mutation Tests in Colorectal Cancer Patients. Br J Cancer. 2017 May 9;116(10):1271-1278. Pubmed ID 28399112<\/a><\/td>\n<\/tr>\n
\"\"<\/a><\/td>\nEntroGen PCR Analysis Software (EPAS). Streamline reporting with simple data interpretation<\/strong><\/a>
Easy-to-interpret reports provide results that can be exported for integration with laboratory information management systems (LIS\/LIMS)<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Click to download lot-specific quality control data for your product:<\/p>\n

Download<\/span><\/a><\/a><\/u><\/p>\n

 <\/p>\n

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Cat Number: CRCDX-RAS<\/strong><\/p>\n

The CRCdx\u00ae RAS Mutation Detection Kit is a real-time PCR-based in vitro diagnostic test that detects 35 KRAS and NRAS somatic mutations in colorectal cancer (CRC) tissue samples, helping identify patients who may benefit from Vectibix\u00ae (panitumumab) treatment.<\/p>\n

 <\/p>\n