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Biocartis Continues Push Into US Market Through Thermo Fisher Deal, CDx Partnerships

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NEW YORK (GenomeWeb) – After recently establishing its first US subsidiary and striking a distribution partnership with Thermo Fisher Scientific, Swiss in vitro diagnostics developer BioCartis this week provided more detail on its gradual push into the US market in the second half of 2017 and beyond.

On a conference call with investors following release of its first-half earnings this week, Biocartis CEO Herman Verrelst noted that the company has hired a new US general manager, a core team, and a sales team for training Thermo Fisher employees, primarily regarding BioCartis' Idylla molecular diagnostics platform.

"Although we are still in the early stages, we're pleased to report our first commercial placement in the US as of today," Verrelst stated during the call.

The company, which in April said it would establish its US subsidiary in the New Jersey area, scheduled the start of its sales force training earlier this month in Houston, but Hurricane Harvey hampered its efforts. Verrelst said that Biocartis will have to reschedule training sessions, but "despite the reorganizing, things are progressing well."

"Our collaboration with Thermo Fisher in the US is still ramping up, [as] it takes time to train the sales force," he added.

Biocartis plans to train 150 Thermo Fisher employees to sell its Idylla system, build a pipeline in the US, and more importantly, meet the end users and pathologists who will be using the platform. Biocartis is also ramping its own team in the US to support and train Thermo Fisher staff as well as engage directly with end users.

In the second half of 2017 Biocartis will pursue this mixed model, and Verrelst said that he believes that these efforts will begin to drive growth for the company in the tail end of 2017 and following years.

The company also recently received its first 510(k) clearance from the US Food and Drug Administration for its viral detection panel, which is also expected to facilitate its entry into the US market.

In the first half of 2017 a companion diagnostics development partnership between Biocartis Abbott expired, which was reflected in a 79 percent drop in collaboration revenue in H1 2017 that contributed to an overall 3 percent decline in revenues. In the conference call, Verrelst stated that it is currently securing collaboration deals with three undisclosed pharmaceutical companies.

Verrelst emphasized that Biocartis has recently redirected internal resources to specifically focus on managing CDx relationships with US-based pharmaceutical companies in the coming year. He believes that the recent FDA 510(k) clearance has also given momentum to the CDx negotiations.

"As we build our [Idylla] menu, we have a number of parallel discussions going on with potential pharma partners, but … are not allowed to disclose with whom at this time," he said.

According to Verrelst, the company is investing in three major areas: assay development, product development, and collaboration with pharmaceutical partners. Third-party companies will develop their assays on the Idylla platform on what Verrelst referred to as a "shared risk, shared reward basis."

Verrelst said that Biocartis aims to secure least one pharmaceutical deal by the end of the year, and that it is currently in the final stages of concluding that deal.  

He also added that the company is "choosing its partners carefully… because it is important to take a step-wise approach, carefully proving performance of the platform assay, step by step, one by one, and then grow the ecosystem around the platform going forward."

Moving forward, Biocartis CFO Ewoud Welten stated that the company will see growth in H2 2017 due the start of US commercialization, the recent CE marking of its EFGR test, further menu expansion, and a growing interest from pharmaceutical and biotech companies in the Idylla platform.