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Biocartis Increases Instrument Placements, Cartridge Volume in Q3; Inks Japan Distribution Deal

NEW YORK – Molecular diagnostics company Biocartis reported on Thursday that it saw an expansion of its installed instruments base in the third quarter, with the US market representing 40 percent of new Idylla instrument placements.

The company also reported a 27 percent year-over-year increase in commercial cartridge volumes, predominantly driven by Europe and rest-of-world markets, and said the development of its liquid biopsy Idylla ctEGFR Mutation Assay during Q3 resulted in the test's launch on Oct. 25.

Biocartis ended the quarter with €197 million ($212.3 million) in cash. The company reiterated its full-year 2019 guidance and continues to expect installed base growth in the range of 325 to 350 Idylla instruments, an increase in commercial Idylla cartridge volume of 30 percent to 35 percent, and a cash position in the range of €170 million to €175 million.

For 2020, the firm is expecting US market clearance for its Idylla MSI Test for colorectal cancer via a 510(k) submission to the US Food and Drug Administration, along with a PMA application for the Idylla RAS tests. Biocartis is also expecting to launch the Idylla GeneFusion Panel for lung cancer in 2020, and said it will continue to place Idylla instruments at European sites in Q4 2019, as a preparation for the clinical validation studies of the Idylla Oncotype DXx IVD Breast Recurrence Score Test, which are expected to start in 2020.

"Next to maintaining business performance in Europe and RoW markets, a key objective for our organization in Q3 2019 was to initiate the implementation of the new go-to market strategy for the US, aimed at facilitating a faster ramp-up of US cartridge volumes," Biocartis CEO Herman Verrelst said in a statement. "As part of that implementation, all Idylla customers were successfully transitioned from Fisher Healthcare to Biocartis and our US sales organization was strengthened. The response from US customers was positive and supportive and an increasing number of them finalized their internal implementation activities, allowing them to start directing testing volumes to the Idylla platform."

He further noted that the company's implementation efforts for the US market are ongoing and will continue in the fourth quarter.

In a separate announcement on Thursday, the company said that it has signed a distribution agreement for its Idylla products in Japan with Nichirei Biosciences. Nichirei has completed the registration of the Idylla instrument and console with the Pharmaceuticals and Medical Devices Agency in Japan and will now offer the platform in combination with Idylla RUO assays to local pathology laboratories in Japan.

Biocartis also said on Thursday that €150 million of its 4.00 percent senior unsecured convertible bonds due 2024 have been admitted to trading and listing on the regulated market of Euronext Brussels. Trading of the convertible bonds is expected to commence on or around Nov. 15.