{"id":52166,"date":"2024-09-25T15:26:51","date_gmt":"2024-09-25T13:26:51","guid":{"rendered":"https:\/\/quimark.com\/?p=52166"},"modified":"2024-11-18T08:32:58","modified_gmt":"2024-11-18T07:32:58","slug":"biomeone-2","status":"publish","type":"post","link":"https:\/\/quimark.com\/en\/biomeone-2\/","title":{"rendered":"BiomeOne\u00ae"},"content":{"rendered":"

[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d background_color=\u201d#002855\u2033 custom_padding=\u201d6px||6px||true|false\u201d global_colors_info=\u201d{}\u201d][et_pb_row _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d custom_padding=\u201d15px||9px||false|false\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d global_colors_info=\u201d{}\u201d][et_pb_text _builder_version=\u201d4.27.0\u2033 _module_preset=\u201ddefault\u201d text_font=\u201d|700|on||||||\u201d text_text_color=\u201d#FFFFFF\u201d text_font_size=\u201d46px\u201d text_line_height=\u201d1.2em\u201d header_font=\u201d|700|||||||\u201d header_text_color=\u201d#FFFFFF\u201d header_font_size=\u201d46px\u201d header_line_height=\u201d1.2em\u201d background_enable_color=\u201doff\u201d text_orientation=\u201dcenter\u201d width=\u201d66%\u201d module_alignment=\u201dcenter\u201d custom_padding=\u201d42px|30px|18px|30px|false|false\u201d header_text_color_tablet=\u201d#FFFFFF\u201d header_text_color_phone=\u201d#FFFFFF\u201d header_text_color_last_edited=\u201don|phone\u201d header_font_size_tablet=\u201d46px\u201d header_font_size_phone=\u201d22px\u201d header_font_size_last_edited=\u201don|phone\u201d global_colors_info=\u201d{}\u201d]<\/p>\n

BiomeOne\u00ae<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d custom_padding=\u201d10px||4px|||\u201d global_colors_info=\u201d{}\u201d][et_pb_row column_structure=\u201d1_4,3_4\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d custom_margin=\u201d18px|auto||auto||\u201d global_colors_info=\u201d{}\u201d][et_pb_column type=\u201d1_4\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d global_colors_info=\u201d{}\u201d][et_pb_image src=\u201dhttps:\/\/quimark.com\/wp-content\/uploads\/2024\/07\/4_2-scaled.jpg\u201d title_text=\u201d4_2\u2033 _builder_version=\u201d4.27.0\u2033 _module_preset=\u201ddefault\u201d global_colors_info=\u201d{}\u201d][\/et_pb_image][et_pb_image src=\u201dhttps:\/\/quimark.com\/wp-content\/uploads\/2024\/05\/biomeone.png\u201d title_text=\u201dbiomeone\u201d _builder_version=\u201d4.24.3\u2033 _module_preset=\u201ddefault\u201d width=\u201d100%\u201d global_colors_info=\u201d{}\u201d][\/et_pb_image][\/et_pb_column][et_pb_column type=\u201d3_4\u2033 _builder_version=\u201d4.24.2\u2033 _module_preset=\u201ddefault\u201d global_colors_info=\u201d{}\u201d][et_pb_text _builder_version=\u201d4.27.0\u2033 text_font=\u201d|600|||||||\u201d text_text_color=\u201d#c8102e\u201d text_font_size=\u201d24px\u201d text_line_height=\u201d1.8em\u201d custom_margin=\u201d||-1px|||\u201d custom_padding=\u201d||17px|||\u201d hover_enabled=\u201d0\u2033 global_colors_info=\u201d{}\u201d sticky_enabled=\u201d0\u2033]<\/p>\n

Microbiota Analysis for Immunotherapy<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=\u201d4.27.0\u2033 text_font=\u201d||||||||\u201d text_text_color=\u201d#000000\u2033 text_font_size=\u201d17px\u201d text_line_height=\u201d1.8em\u201d ol_line_height=\u201d1.8em\u201d header_3_font=\u201d|700|||||||\u201d header_3_font_size=\u201d23px\u201d header_3_line_height=\u201d1.5em\u201d custom_margin=\u201d-10px|||||\u201d hover_enabled=\u201d0\u2033 global_colors_info=\u201d{}\u201d sticky_enabled=\u201d0\u2033]<\/p>\n

The first test to support the prediction of the response to cancer immunotherapy based on the microbiota<\/p>\n

What is BiomeOne?<\/h3>\n

BiomeOne is the first test CE-IVD on fecal sample which can provide support in <\/span>forecast of the <\/span>response to immunotherapy<\/span> (Immune Checkpoint Inhibitors, ICI).<\/span><\/p>\n

On a simple stool sample<\/span>, the laboratory performs the BiomeOne test, which determines the patient's intestinal microbiota and provides three types of information:<\/p>\n

1) Clinical Response<\/span>
BiomeOne can identify patients who are most likely to benefit (responders) or not (non-responders) from treatment with anti-tumor immunotherapy with ICIs (e.g., CTLA-4, anti-PD-1, or anti-PD-L1).\u00a0 The BiomeOne test and its parameter \u201c<\/span>Clinical Response\u201d meet the requirements of the European Directive 98\/79 CE for in vitro diagnostic medical devices. <\/span>The test result therefore provides potentially useful information when choosing a therapeutic option based on the patient's microbiota profile.<\/p>\n

2) Tolerability (irAEs)<\/span>
Additionally, the BiomeOne test results include the parameter \u201cTolerability\u201d, that is, the <\/span>likelihood that the patient will experience adverse events related to immunotherapy (immune-related adverse events, irAEs)<\/em>. <\/span>\u00a0<\/span>The \u201cTolerability\u201d parameter is for research-use only (RUO).<\/span><\/p>\n

3) “Diversity<\/span>“, “Bacterial richness<\/span>" And "Enterotype<\/span>“
These three parameters\u00a0are scientifically consolidated and <\/span>can contribute to the overall assessment of the patient's intestinal microbiota.<\/span><\/p>\n

Intended Use (in English)\u00a0<\/a><\/span><\/p>\n

Example of report (in English)<\/a><\/p>\n

\"\"<\/a><\/p>\n

<\/span>Please note: The results described in the BiomeOne report are intended as additional information for the treating physician and should not be used as the sole basis for any treatment decision.<\/strong><\/p>\n

<\/strong><\/p>\n

More accurate prediction of clinical response<\/h3>\n

BiomeOne\u00ae has a prediction sensitivity of >80% based on samples from cancer patients across Europe and the United States.<\/p>\n

The prediction is better than 20% compared to the PD-L1 expression assay (sensitivity ~65%).<\/p>\n

BiomeOne is based on data from more than 10,000 patients with non-small cell lung cancer, renal cell carcinoma, and malignant melanoma.<\/p>\n

Single sample, non-invasive<\/h3>\n

Only one stool sample is needed to perform a thorough microbial DNA analysis.<\/p>\n

Validated and certified<\/h3>\n

BiomeOne has been validated as part of a clinical study* with 80 patients with advanced cancer (NSCLC, RCC, Melanoma). The test is a CE-marked in vitro diagnostic, performed in the laboratories of the Austrian company Biome-Dx.<\/p>\n

 <\/p>\n

\u00a0* I. Robinson et al. Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types. Cancers (Basel). 2023 Jun 21;15(13):3268. doi: 10.3390\/cancers15133268.\u00a0 \u00a0<\/span><\/a><\/p>\n

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For information<\/span><\/h2>\n

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BiomeOne\u00aeMicrobiota Analysis for ImmunotherapyThe first test to support the prediction of the response to cancer immunotherapy based on the microbiota What is BiomeOne? BiomeOne is the first CE-IVD test on a fecal sample that can provide support in the prediction of the response to immunotherapy (Immune Checkpoint Inhibitors, ICI). On a simple stool sample, the laboratory performs the BiomeOne test, [\u2026]<\/p>","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[13],"tags":[],"class_list":["post-52166","post","type-post","status-publish","format-standard","hentry","category-prodotti"],"yoast_head":"\nBiomeOne\u00ae - eurobiodid - Oncologia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quimark.com\/en\/biomeone-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BiomeOne\u00ae - eurobiodid - Oncologia\" \/>\n<meta property=\"og:description\" content=\"BiomeOne\u00aeAnalisi del Microbiota per ImmunoterapiaIl primo test\u00a0 per supportare la previsione della risposta all\u2019immunoterapia oncologica basato sul microbiota Cos\u2019\u00e8 BiomeOne ? BiomeOne \u00e8 il primo test CE-IVD su campione fecale che pu\u00f2 fornire\u00a0 supporto nella previsione della risposta all\u2019immunoterapia (Immune Checkpoint Inhibitors, ICI). 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