COMPANY:

Biocartis

"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."

"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."

"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."

"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."

"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)."

"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."

"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."

"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."

"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."

"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."

"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)."

"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."

"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)."

"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"

"Biocartis Group NV...today announces that it has received a EUR 1.4 million grant from VLAIO, the Flanders organization for Innovation & Entrepreneurship, for the ongoing development of a new generation technology that will be deployed on the easy-to-use and fully automated molecular diagnostics platform Idylla™...The VLAIO grant is intended to support the ongoing development of a new Idylla™ technology, which will enable the off-line customization of the Idylla™ cartridge. The first generation Idylla™ cartridges contain not only the generic components for sample preparation and biomarker detection, but also the biomarker-specific reagents."

"Biocartis Group NV...today announces to have signed a new agreement with AstraZeneca...aimed at providing access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in Biocartis’ European and global distributor markets to support the identification of patients with EGFR mutations...The new project expands the existing master collaboration agreement between Biocartis and AstraZeneca, which was established to promote and bolster access to faster molecular diagnostic biomarker results."

"Biocartis Group NV (the ‘Company’ or ‘Biocartis’)...and SkylineDx...today announce the signing of a new partnership agreement which targets the development of SkylineDx’ novel proprietary test, the Merlin Assay, on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™. This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network."

"Biocartis Group NV...today announces the US FDA 510(k) submission1 of its Idylla™ MSI Test for use as an in vitro diagnostic device intended for the identification of microsatellite instability (MSI) status in colorectal (colon) cancer (CRC) to aid in the differentiation between sporadic CRC and potential Lynch syndrome."

"Biocartis Group NV...today announces the launch of the highly innovative Idylla™ GeneFusion Assay (RUO). The Assay detects, in one single cartridge, a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research. The Idylla™ GeneFusion Assay (RUO) is therefore expected to provide a much faster testing solution for laboratories, compared to other testing methods including Next generation Sequencing (NGS) testing which often takes days or even weeks before results are available."

"Biocartis Group NV…today announces the publication of a global multicenter real world study1 with its Idylla™ MSI Assay. This multi-center study is the largest so far for Biocartis and demonstrates excellent performance of the Idylla™ MSI Assay with a very low failure rate…In this real-world global study, 44 clinical centers performed Idylla™ MSI testing on 1,301 archived colorectal cancer FFPE3 tissue sections. Idylla™ results were compared against routine diagnostic testing in those sites, demonstrating excellent concordance with immunohistochemistry (96%4) and routine molecular methods (98%). Additionally, the failure rate of the Idylla™ MSI Assay was very low (0.23%; 3/1301), underlining the robustness of the Idylla™ MSI Assay."

"Biocartis Group NV...today announces it has signed a license,development and commercialization agreement with GeneproDx...for the development of GeneproDx’s novel genomic test ThyroidPrint® on Biocartis’ rapid and easy to use molecular diagnostics platform Idylla™. Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla™ ThyroidPrint® test, whereas Biocartis will be responsible for the distribution of the ThyroidPrint® on Idylla™ through its growing commercial infrastructure of Idylla™ instruments across the globe."

"Biocartis Group NV…today announces that the Company is currently in discussions with Exact Sciences regarding the potential termination of the agreements that the Company had previously entered into with Genomic Health, Inc. (now part of Exact Sciences) in relation to the development of an in vitro diagnostic version of the Oncotype DX Breast Recurrence Score® test."

"Biocartis Group…today announces that it has received a EUR 1.2 million grant from VLAIO, the Flanders organization for Innovation & Entrepreneurship, for the development of the highly innovative GeneFusion Assay on its easy, rapid molecular and fully automated diagnostics platform Idylla™...Biocartis expects to launch its Idylla™ GeneFusion Assay as a Research Use Only (RUO) assay in Q1 2021."

"Biocartis Group NV…today announces the expansion of its collaboration with LifeArc, a UK based independent medical research charity, with a new agreement aimed at the development of highly innovative prototype assays…The new license and development agreement is an extension of the existing partnership between LifeArc and Biocartis, which is today focused on the development and the commercialization of the Idylla™ ABC (Advanced Breast Cancer) assay. This assay is positioned to target a multi-gene panel of predictive and resistance-inducing mutations based on an FFPE3 sample type."