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Tag Archives: Biocartis—

Biocartis Idylla platform, 10/17

October 2017—Biocartis Group announced the availability of its Idylla platform in the United States. The Idylla is a fully automated, walkaway, real-time PCR system with a hands-on time of less than two minutes. Its access on-demand design and assay turnaround time of between 90 and 150 minutes allow pathologists to analyze samples at any time, without the need for batching or for trained operators, in virtually any laboratory. The Idylla console and instrument are class II exempt.

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Idylla IVD Oncotype DX test in development

Sept. 27, 2017—Genomic Health and Biocartis Group announced an exclusive agreement to develop an in vitro diagnostic version of the Oncotype DX Breast Recurrence Score test on Biocartis’ Idylla platform that can be performed locally by laboratory partners and in hospitals around the world. The Oncotype DX Breast Recurrence Score test examines the activity of 21 genes in a patient’s ...

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FDA clears Idylla respiratory panel

Sept. 25, 2017—Biocartis Group announced that the U.S. FDA has granted 510(k) clearance for the Idylla Respiratory (IFV-RSV) Panel, a fully automated molecular diagnostic test developed by Janssen Diagnostics. The test is intended for the detection of various strains of influenza virus and respiratory syncytial virus using Biocartis’ molecular diagnostics platform Idylla. The panel can be performed in approximately 50 ...

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Fully automated assays for colorectal cancer, 2/16

February 2016—Biocartis launched two products on its molecular diagnostics platform Idylla. The first offering, the Idylla ctBRAF Mutation Assay, uses blood plasma as a sample. The assay can potentially act as a substitute for tissue biopsy testing in melanoma and colorectal and lung cancers, as well as conditions such as hairy cell leukemia and histiocytosis. It has a turnaround time of approximately 90 minutes with less than one minute of hands-on time.

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Biocartis launches automated liquid biopsy assay

Jan. 22, 2016—Molecular diagnostics company Biocartis has launched two new products on its Idylla platform. The Idylla ctBRAF Mutation Assay uses blood plasma as a sample, which is less invasive to obtain compared with tissue biopsies. The second assay the tissue biopsy Idylla NRAS-BRAF-EGFR S492R Mutation Assay. This assay offers a complete RAS-BRAF analysis that can be performed on a ...

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CE mark for Biocartis’ respiratory panel

Dec. 9, 2015—Belgian molecular diagnostics company Biocartis has launched its first infectious disease test on the Idylla platform. The Idylla Respiratory IFV-RSV Panel was developed by Janssen Diagnostics and is intended for the detection of various strains of the influenza respiratory syncytial viruses. The panel received CE-IVD marking Nov. 18 and is being launched for commercial use in Europe and ...

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KRAS mutation test receives CE-IVD marking, 10/15

Biocartis launched its CE-IVD Idylla KRAS Mutation Test, a sample-to-result test for the fast, accurate, and reproducible detection of 21 relevant mutations in the KRAS oncogene. The fully automated test, for routine use, detects all clinically relevant driver mutations of the KRAS oncogene in tissue of colorectal cancers at a sensitivity of five percent.

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Biocartis, Fast-track sign strategic collaboration, 9/15

Biocartis and Fast-track Diagnostics have entered into a strategic collaboration to develop a range of multiplex infectious disease tests to run on the Biocartis Idylla system. The two companies plan to collaborate on a new approach to infectious disease diagnostics, “syndromic multiplex testing,” which enables the identification of a broad range of disease pathogens in a single test.

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BRAF liquid biopsy data, 7/15

July 2015—Biocartis presented liquid biopsy data from the company’s BRAF mutation study at the American Society of Clinical Oncology annual meeting in June. The study, in collaboration with Bart Neyns, MD, PhD, University Hospital Brussels, showed that BRAF oncogene mutations monitored in plasma from metastatic melanoma patients on Biocartis’ Idylla system were significantly associated with treatment response and progression.

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