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Biocartis Q1 Cartridge Volume Grows Sharply, Firm Suspends Placements Guidance

NEW YORK ─ Biocartis on Thursday reported 68 percent growth in year-over-year commercial cartridge volume for the first quarter of 2020.

Mechelen, Belgium-based Biocartis also said that in Q1, it saw slower than expected installed base expansion due to the COVID-19 pandemic, with the main impact occurring in Southern European, US, and rest of the world markets.

During Q1, the US represented over 40 percent of new Idylla instrument placements, but growth of both installed base expansion and commercial cartridge volume stalled due to the COVID-19 impact, as access to hospitals and labs was restricted, the firm said.

Biocartis noted that in Q1 it expanded its partnerships in oncology with AstraZeneca by participating in a study of liquid biopsy testing using the Biocartis research-use-only Idylla ctEGFR Mutation Assay, and it has engaged in a project with Bristol Myers Squibb aimed at pursuing the registration of its Idylla MSI assay as a companion diagnostic test for metastatic colorectal cancer in China.

The company said it also expanded a partnership in infectious diseases with Seattle-based Immunexpress for the joint commercialization in Europe of the SeptiCyte Rapid Test on Idylla, which recently received CE marking.

The company said that with support from multiple undisclosed partners, it is developing the Idylla SARS-CoV-2 test for the virus that causes COVID-19 and rapid testing of people with flu-like symptoms. The test will be based on the Idylla Respiratory Panel that received US Food and Drug Administration 510(k) clearance in 2017 and is being designed to detect SARS-CoV-2 from respiratory samples such as nasopharyngeal swabs.

Together, the SeptiCyte Rapid Test and Idylla SARS-CoV-2 test have potential to identify patients with severe disease, the firm said, adding that a recent study has indicated that sepsis is the most frequently observed complication in COVID-19.

The firm anticipates launching the Idylla SARS-CoV-2 test in the second half of this year, subject to a successful FDA Emergency Use Authorization. Biocartis further expects to see US FDA 510(k) clearance of the SeptiCyte Rapid Test around the same time.

The company said that it anticipates submission of the Idylla MSI Test for clearance with the FDA toward the end of 2020. It is further developing the Idylla GeneFusion Assay for lung cancer and expects to launch it for research use toward the end of this year. The firm anticipates launching clinical validation studies for the Idylla IVD Oncotype DX Breast Recurrence Score test in France and Germany this year.

At the end of Q1, the firm had €170.1 million ($183.6 million) in cash.

Due to the COVID-19 pandemic, new Idylla instrument placements slowed toward the end of Q1 as access to hospitals was restricted, the firm said. The company has suspended its guidance on 2020 instrument placements.

The firm appointed Jean-Marc Roelandt, previously the CFO of MDxHealth, as its new CFO.