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23d
Biocartis and Merck to collaborate on improving patient access to personalized medicine in Middle East and North Africa (MEA) region (Biocartis Press Release)
"Biocartis...announced an expansion of its collaboration with Merck Serono Middle East and Merck Saudi Ltd...The collaboration aims to improve patient access to RAS biomarker testing in the Middle East and North Africa (MEA) region."
Licensing / partnership
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Idylla™ KRAS Mutation Test • Idylla™ NRAS-BRAF Mutation Test
7ms
Biocartis hosts corporate workshop and announces seven Idylla™ abstracts to be presented at AMP 2023 annual meeting (Biocartis Press Release)
"Biocartis...announces that it will host a free corporate workshop at the Annual Meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 14-18 November 2023 in Salt Lake City, Utah (US)."
Clinical data
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
7ms
Press release Biocartis Group NV: Four Abstracts Showing Excellent Data for Idylla Presented at European Society of Molecular Oncology Congress (ESMO) (GlobeNewswire)
"Biocartis Group NV...announces that four study abstracts on Idylla™ have been selected for poster presentations at the international ESMO (European Society of Molecular Oncology) congress, taking place between 20-24 October 2023 in Madrid (Spain). The studies show excellent data for the Idylla™ GeneFusion Assay and Idylla™ EGFR Mutation Assay....The first study prospectively tested lung cancer samples on the Idylla™ Platform as part of routine2 lung profiling locally and from over 60 UK hospitals....The second abstract presents the results of a multicenter study that was conducted in a routine clinical2 setting involving 12 clinical centers across Europe....The third abstract presents the results of the ORIGEN study, a multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain (in collaboration with AstraZeneca Spain)."
Clinical data
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Idylla™ GeneFusion Assay • Idylla™ EGFR Mutation Test
8ms
Press release Biocartis group NV: Biocartis honors breast cancer awareness month with launch of breast cancer portfolio (Biocartis Press Release)
"Biocartis Group NV...announces the launch of the new Breast Cancer Portfolio during the Breast Cancer Awareness month: the Idylla™ PIK3CA-AKT1 Mutation Assay and, in collaboration with APIS Assay Technologies (APIS), the APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations Kit."
Licensing / partnership • Launch
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APIS Breast Cancer Subtyping Kit • APIS ESR1 Mutations Kit • Idylla™ PIK3CA-AKT1 Mutation Assay
8ms
Press release Biocartis Group NV: Biocartis Announces Expansion of its Collaboration with APIS Assay Technologies to Commercialize the APIS ESR1 Mutations Kit (GlobeNewswire)
"Biocartis Group NV...and APIS Assay Technologies Ltd...today announced the expansion of their partnership to include the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ worldwide commercial network....'Together with the Idylla™ PIK3CA-AKT1 Mutation Assay and the APIS Breast Cancer Subtyping Kit we will be able to provide a comprehensive menu of products in the breast cancer domain to our customers.'"
Licensing / partnership
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APIS ESR1 Mutations Kit
10ms
Biocartis partners with Lilly to explore biomarker testing for NSCLC patients using the Idylla platform (Biocartis Press Release)
"Biocartis Group NV...announced that they have entered into a new post commercial collaboration program with Lilly, a global pharmaceutical company. This program will explore the advantages of adding the Biocartis Idylla Platform to a molecular diagnostics workflow in global clinical labs via a study in hospitals across Spain."
Licensing / partnership
1year
Biocartis and HiloProbe to collaborate on colorectal cancer test (Biocartis Press Release)
"Biocartis Group NV...announce that they entered into a collaboration that will initially focus on the commercialization of ColoNode, a CE-marked IVD gene expression signature test that can help detect nodal metastasis in colorectal cancer (CRC) patients. ColoNode will be distributed as a manual kit by Biocartis to expert laboratories in selected European countries."
Licensing / partnership
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ColoNode®
1year
Press release Biocartis Group NV: Biocartis and APIS Assay Technologies Sign Collaboration to Develop and Commercialise a Breast Cancer Subtyping Test on the Idylla platform (GlobeNewswire)
"Biocartis Group NV...and APIS Assay Technologies Ltd...announce that they have entered into a new partnership agreement which targets the development of APIS’ Breast Cancer Subtyping assay on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™....Under the terms of the partnership agreement, APIS will lead the development of the Breast Cancer Subtyping test on Idylla™, while Biocartis will lead the commercialisation through its growing Idylla™ network."
Licensing / partnership
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APIS Breast Cancer Subtyping Kit
1year
Press release Biocartis Group NV: Biocartis announces the US FDA 510(k) clearance for the Idylla MSI Test (GlobeNewswire)
"Biocartis Group NV...announces the U.S. Food and Drug Administration (FDA) 510(k) clearance for its fully automated Idylla™ MSI Test. This 510(k) clearance reinforces Biocartis’ commitment to enable clinical molecular diagnostics in the U.S. Now, labs of all sizes can benefit from Idylla™’s high sensitivity, unmatched ease-of-use, and rapid turnaround times."
FDA event
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Idylla™ MSI Test
over1year
Press release Biocartis Group NV: Biocartis Announces the Launch of the First Assay Developed With the New Idylla Flex Technology (GlobeNewswire)
"Biocartis Group NV...announces the launch of the Idylla™ IDH1-2 Mutation Assay Kit (RUO)1 among selected customers. The assay is the first test developed with the new Idylla™ FLEX technology that separates the generic components of an Idylla™ test from the test-specific components. The Idylla™ IDH1-2 Mutation Assay Kit (RUO) will become globally available to customers during the second half of 2023."
Launch
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Idylla™ IDH1-2 Mutation Assay
over1year
New Idylla EGFR study shows reduction of time-to-treatment by 48% for Lung cancer patients (Biocartis Press Release)
"Biocartis Group NV...announces the recent publication of a new, large prospective study1 demonstrating that the Idylla™ EGFR Mutation Test (CE-IVD2) leads to the significant reduction of the time-to-treatment by 48% or on average 16.8 days faster than NGS testing for EGFR positive patients. This shows Idylla™’s potential to improve strategic treatment decisions within a multidisciplinary team for patients with advanced non-small cell lung cancer (NSCLC)....The study showed a concordance of 98.7% between the Idylla™ EGFR Mutation Test and the NGS panel. The lab turnaround time was faster for the Idylla™ EGFR Mutation Test by an average of 12.4 days. In the EGFR positive cohort, the Idylla™ EGFR Mutation Test led to a 48% reduction and on average 16.8 days faster turnaround time."
Clinical data
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Idylla™ EGFR Mutation Test
over1year
Biocartis announces nine Idylla™ studies to be published at upcoming AMP 2022 annual meeting (Biocartis Press Release)
"Biocartis Group NV...announces the publication of nine performance study abstracts of its fully automated molecular diagnostics Idylla™ platform and assays at the annual meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 1-5 November in Phoenix, Arizona (US). The studies were performed by a variety of US laboratories and research institutes."
Clinical data
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Idylla™ GeneFusion Assay • Idylla™ EGFR Mutation Test • Idylla™ MSI Test • Idylla™ NRAS-BRAF Mutation Test
over1year
Biocartis initiates commercialization in Europe of HepatoPredict (CE-IVD) test for liver cancer patients (Biocartis Press Release)
"Biocartis Group NV...announces the start of the commercialization in Europe of the HepatoPredict test as a CE-IVD marked manual kit. The test, developed by Ophiomics, is a prognostic diagnostic test that supports the decision of liver transplantation in patients with Hepatocellular Carcinoma (HCC)."
European regulatory
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HepatoPredict
over1year
Ophiomics @ European Congress of Pathology (Ophiomics Press Release)
"Ophiomics is attending ECP from 3-7 of September in Basel, Switzerland. We are be presenting HepatoPredict with our partner and distributor Biocartis. Come visit us at Biocartis Booth Nr 22."
Clinical data
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HepatoPredict
over1year
Biocartis initiates commercialization in Europe of SkylineDx’s Innovative Merlin™ Assay (CE-IVD) for melanoma patients (Biocartis Press Release)
"Biocartis Group NV...today announces the start of the commercialization in Europe of SkylineDx’s innovative Merlin Assay as a CE-IVD marked manual kit. The test, developed by SkylineDx together with the Mayo Clinic (US), aims to predict a melanoma patient’s risk of nodal metastasis and may help safely forgo an invasive surgery, which is now often performed to determine metastatic spread of the cancer for staging purposes."
Commercial
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Merlin Assay
almost2years
Press release Biocartis Group NV: Biocartis Announces New Agreement with AstraZeneca for the Development and Marketing of a Companion Diagnostic Test for Tagrisso (Biocartis Press Release)
"Biocartis Group NV...announced that it has entered into an agreement with AstraZeneca...aimed at the development and applicable pre-market notification or approval with the US FDA of a novel companion diagnostic1 (CDx) test on Biocartis’ molecular rapid and easy-to-use diagnostics Idylla™ platform, for use with Tagrisso® (osimertinib)....Under the terms of the agreement, Biocartis and AstraZeneca will co-lead the development and applicable pre-market notification or approval of the Idylla™ EGFR CDx Assay intended to aid in identifying patients with non-small cell lung cancer (NSCLC) who may respond to treatment with Tagrisso®. In addition to FFPE2 tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates3 for use with the Idylla™ EGFR CDx Assay, to expand patient access to testing."
Licensing / partnership
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Idylla™ EGFR Mutation Test
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Tagrisso (osimertinib)
almost2years
Press release Biocartis Group NV: Biocartis Announces Launch of its Rapid CE-marked IVD Idylla GeneFusion Panel for Fast Treatment Decisions in Lung Cancer (Biocartis Press Release)
"Biocartis Group NV...announces the CE-marking of its fully automated Idylla™ GeneFusion Panel (CE-IVD). The Panel detects in one single cartridge ALK, ROS1, RET and METex14 skipping, a wide range of actionable targets relevant in non-small cell lung cancer (NSCLC). Designed for use in clinical laboratories, the Panel provides comprehensive testing results within 180 minutes, significantly faster than currently available testing methods which often take days or even weeks before results are available."
Launch Europe • European regulatory
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Idylla™ GeneFusion Assay
2years
New study led by Memorial Sloan Kettering Cancer Center (NY, US) shows Idylla™ Gene Fusion Assay enables more rapid screening of targetable fusions compared to routine methods (Biocartis Press Release)
"Biocartis Group NV...announces the publication of a new study in the Journal of Molecular Diagnostics on the Idylla™ GeneFusion Assay (RUO) for rapid detection of targetable fusions involving ALK, ROS1, RET, and NTRK1/2/3 and MET exon 14 skipping mutations."
Clinical data
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Idylla™ GeneFusion Assay
2years
Biocartis announces presentation of first prospective validation study data of Merlin test by partner SkylineDx at EADO 2022 conference (Biocartis Press Release)
"Biocartis Group NV...announced that its partner SkylineDx will present new data showing that its Merlin Test was able to prospectively reduce more than 37% of surgeries in a noninterventional study for newly diagnosed melanoma patients. The abstract publication receives a designated oral presentation during the 18th Congress of the European Association of Dermato-oncology (EADO) in Sevilla, Spain (21-23 April 2022)."
Clinical data
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Merlin Assay
over2years
Biocartis and Ophiomics to Collaborate on Liver Cancer Test (Biocartis Press Release)
"Biocartis Group NV...and Ophiomics...announce that they entered into a collaboration which will initially focus on the commercialization of HepatoPredict™, a prognostic gene expression signature test to help identify which patients will benefit from curative-intent surgery, in particular liver transplantation. HepatoPredict™ will be distributed by Biocartis in Europe as a manual kit mainly addressing centralized expert laboratories, and the test may later be translated into a version on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™...HepatoPredict™ will be launched as a CE-marked IVD manual kit in Q1 2022. The partnership will initially focus on Biocartis’ commercialization of the manual kit in Europe."
Licensing / partnership
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HepatoPredict
over2years
Large UK study shows rapid EGFR testing with Idylla™ alongside NGS has potential to enhance lung cancer patient health outcomes (Biocartis Press Release)
"Biocartis Group NV...announces the publication of a large new study comparing the difference in turnaround time between in-house automated rapid PCR3-based EGFR analysis and Next-Generation Sequencing (NGS) by an external laboratory, with a focus on patient health outcome. The study concluded that a dual PCR and NGS testing strategy for stage IV non-squamous, non-small cell lung cancer (NSCLC) patients has the potential to improve care and survival outcomes by providing access to the right test at the right time...In the study, 102 test results for lung adenocarcinoma patients were compared using both NGS and Idylla™ EGFR Mutation Test (CE-IVD)."
Retrospective data
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Idylla™ EGFR Mutation Test
over2years
New study demonstrates Idylla™ EGFR Mutation Test (CE-IVD) shortens time to patient management decisions for patients with non-small cell lung cancer (Biocartis Press Release)
"Biocartis Group NV...announces the publication of a new study that demonstrates that the Idylla™ EGFR Mutation Test (CE-IVD) running on Biocartis’ molecular diagnostics Idylla™ platform improves patient management decisions for patients with non-small cell lung cancer (NSCLC) through the faster screening of EGFR mutations...The study compared EGFR mutations analysis between the Idylla™ platform using the Idylla™ EGFR Mutation Test, and NGS in 223 patients with NSCLC. Idylla™ demonstrated 96.4% overall agreement with NGS and did not generate any false positive results"
Clinical data
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Idylla™ EGFR Mutation Test