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Biocartis Q3 Cartridge Volume Grows 61 Percent

NEW YORK – Biocartis on Thursday reported 61 percent growth in year-over-year commercial cartridge volume for the third quarter of 2020.

The Mechelen, Belgium-based firm said that Q3 overall cartridge volumes were back at pre-pandemic levels, and that it is on track to achieve targeted 30 percent growth for full-year 2020.

Biocartis noted there was a return to growth in commercial cartridge volumes in oncology in the US with initial sales of the Idylla SARS-CoV-2 Test, while European markets showed consistent year-over-year growth in oncology, and growth in the rest of the world markets was moderate.

The US market represented 50 percent of all new Idylla placements, while the lingering impact of the pandemic slowed down instrument growth in the rest of the world markets.

Subsequent to the end of the third quarter, Biocartis terminated an agreement with Exact Sciences' Genomic Health last month to develop an in vitro diagnostic (IVD) version of Genomic Health's Oncotype Dx Breast Recurrence Score test on the Idylla platform. However, Biocartis has since launched new projects with GeneproDx and Endpoint Health to develop IVD tests for multiple cancer types and infectious diseases.

Biocartis also expanded a collaboration with UK-based Life Arc in September, with plans to develop infectious and immune-related disease assays on Biocartis' Idylla platform.

"We saw that our Idylla SARS-CoV-2 test is strengthening our footprint within our core customer base that is in need of a platform that delivers rapid response testing, both in oncology and in infectious diseases," Biocartis CEO Herman Verrelst said in a statement. "Barring any pandemic-related deterioration of business conditions toward the end of the year, we are confident that we can deliver on our growth targets for the year."

The company also received a €1.2 million ($1.4 million) grant from the Agency for Innovation and Entrepreneurship (VLIAO), a Flemish government organization, to develop its GeneFusion assay on the Idylla instrument.

In October, the firm launched its CE-marked SeptiCyte Rapid assay on the Idylla platform, which distinguishes sepsis from non-infectious systemic inflammation in patients suspected with sepsis.

Biocartis received CE-marking for its SARS-CoV-2 test earlier this week, which it will offer for clinical use across Europe. The firm submitted the test to the US Food and Drug Administration for Emergency Use Authorization in August and is waiting for a decision.

At the end of Q3, the firm had €137 million ($162 million) in cash.

Biocartis is targeting a year-over-year commercial volume of around 228,000 Idylla cartridges, as well as an installed base growth of around 300 new Idylla instrument placements. The firm expects to submit its Idylla MSI Test for 510(k) clearance with the FDA later this year. It also plans to submit its Idylla RAS test for premarket approval with the FDA in mid-2021.