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The firm expects to validate its test as a triage tool to identify SARS-CoV-2 patients at risk of sepsis and pursue US FDA Emergency Use Authorization.
News items for the in vitro diagnostics industry for the week of April 27, 2020.
In Q1, the US represented more than 40 percent of new Idylla instrument placements, but growth stalled due to COVID-19.
Biocartis will lead commercialization in Europe as the exclusive distributor of the SeptiCyte Rapid test, while Immunexpress will lead commercialization of the test in the US.
The Belgian diagnostics company said it has partnered with Bristol-Myers Squibb to register its MSI test as a companion diagnostic in China.
The partners will extend the lung cancer biomarker study to countries in and outside Europe, and see if liquid biopsy could offer benefits to tissue-based testing.
The diagnostic firms were the final companies in the coverage universe of 360Dx to present at the annual conference.
The company signed a distribution agreement in Japan for its Idylla products and also initiated a listing of €150 million in unsecured convertible bonds.
The Belgian oncology molecular diagnostics firm reported a 17 percent increase in product sales but said that sales of cartridges in the US were lower than expected.
Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.