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Biocartis, SkylineDx Partner to Develop Melanoma Nodal Metastasis Risk Test

NEW YORK – Biocartis said on Thursday that it has partnered with Rotterdam, Netherlands-based SkylineDx to develop that firm's Merlin assay to predict a melanoma patient's risk of nodal metastasis on Biocartis' Idylla platform.

SkylineDx will lead development of the Merlin assay on Idylla, expected to start this year, while Biocartis, based in Belgium, will commercialize the assay in Europe through its Idylla network.

SkylineDx's Merlin assay integrates gene expression data with a patient's age and tumor thickness to reduce the number of unnecessary sentinel lymph node biopsy surgeries.

As part of the agreement, Biocartis said it will invest up to €10 million ($12 million) in secured convertible notes to be issued by SkylineDx in different project-based installments throughout the collaboration.

The Merlin assay is currently available as a laboratory-developed test in SkylineDx's CAP-accredited, CLIA-certified lab in San Diego. The firm is also developing a molecular subtyping test kit for in vitro diagnostic use for the European market.

"Through this collaboration with Biocartis, we enable a broader availability of our test portfolio in melanoma," Dharminder Chahal, CEO of SkylineDx, said in a statement. "SkylineDx focuses on precision diagnostics for all cancer patients and with the addition of this new version of our Merlin assay, more laboratories and care settings will be able to have access to this assay."

Separately, Biocartis on Thursday reported 70 percent year-over-year growth in commercial cartridge volumes for the first quarter of 2021.

Biocartis also said that in Q1, oncology cartridge volumes were ahead of expectations in Europe and distributed markets, while US cartridge volume growth was driven by its Idylla SARS-CoV-2 test.

"Similar to 2020, growing volumes in oncology were supplemented by continued demand for our Idylla SARS-CoV-2 test," Herman Verrelst, CEO of Biocartis, said in a statement. "We made good progress on menu expansion, both in oncology as well as in infectious diseases, and we remain poised for strong growth in 2021."

Biocartis noted that it launched the Idylla GeneFusion assay in Q1, which detects a wide range of biomarkers covering all gene fusions believed to be relevant in cancer research.

Earlier this week, Biocartis filed a 510(k) submission to the US Food and Drug Administration for its Idylla MSI test for use as an in vitro diagnostic device. The firm aims to offer the assay for use in colorectal cancer to distinguish between sporadic CRC and Lynch syndrome.

Biocartis also recently announced a feasibility assessment agreement with Amgen to evaluate the suitability of Biocartis' technology as a potential companion diagnostic for an undisclosed research program. The firms have discontinued their ongoing project in CRC aimed at premarket approval submission of the Idylla RAS test with the US FDA.

For full-year 2021, Biocartis expects a year-over-year growth of 40 to 60 percent in its commercial cartridge volume, or in the range of 320,000 to 370,000 cartridges. The firm also anticipates placing 300 to 350 new Idylla instruments this year.

At the end of Q1, Biocartis had €108.1 million in cash. The firm is targeting to have at least €50 million in cash by the end of 2021, which includes potential investments in upgrading and expanding its infectious disease menu.