Tag Archives: Biocartis

Dec. 3, 2021—Biocartis announced that the FDA granted 510(k) clearance for its SeptiCyte Rapid test, which was developed under partnership with Immunexpress.

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.

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.

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.

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.

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.

April 2015—Biocartis announced it is in the testing phase of a Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp, Belgium, for its Idylla system, a CE-IVD-marked, fully automated molecular diagnostic platform.

November 2014—Biocartis announced the launch of its flagship molecular diagnostics system, Idylla. With Idylla, Biocartis also released its first oncology assay, the Idylla BRAF Mutation Test. Both Idylla and the Idylla BRAF Mutation Test have obtained CE-IVD marking.