NEW YORK (GenomeWeb News) – Five years after its founding, Swiss molecular diagnostics firm Biocartis has transitioned to full commercial mode with the launch of its DMAT platform last week and the completion announced today of its Series D financing round bringing in €34.5 million ($45.0 million).
The financing will go toward the launch of the platform as well as validation of its molecular diagnostics platform called Apollo.
The launch of DMAT marks Biocartis' evolution from a company focused on technology development. Short for Dynamic Multi-Analyte Technology, DMAT uses disposable, microfluidic cartridges for the rapid and sensitive detection of protein and nucleic acid biomarkers.
The firm will ship the system to early access customers it calls Platinum customers during the first six months of the launch, followed by a broader rollout of the platform. DMAT is for research-use only and Biocartis is targeting the instrument at investigators doing preclinical, early clinical, and translational research at biotech and pharmaceutical firms as well as academic centers.
So far, the company has two signed orders for DMAT and is in negotiations with three others, Biocartis CEO Greg Parekh told GenomeWeb Daily News recently.
In preparation of the launch, Biocartis hired Allison Balmer as manager of global marketing for DMAT in September, and it plans to add seven sales and marketing positions, as well as technical support staff, in the short-term. Within the next two-and-a-half years, Parekh added, the plan is to build its sales and marketing staff to about 50 people.
DMAT is listed at €110,000 ($144,000) in Europe with a price still to be determined for the US market. Three assays for use on the platform — a cytokine panel, an oncogene panel, and a cell signaling panel — are also being made available.
DMAT is the first system to be commercially launched by privately held Biocartis, founded in 2007 by Rudi Pauwels, Philippe Renaud, and Nader Donzel, and comes exactly one year after Parekh succeeded Pauwels as CEO as the firm began shifting toward revenue generation.
As part of that change and steps to beef up Biocartis' commercial operations, Parekh created a business unit and eliminated projects that he deemed would take too long to complete. Instead, emphasis was placed on efforts that were closer to being market-ready.
On the content side, Parekh made cancer-related work the main priority and put other initiatives on hold or partnered them out. That decision, he said, was driven by the fact that despite industry-wide efforts to create diagnostic tools, unmet needs remain rampant in oncology.
More bluntly, cancer is a potentially lucrative space for those firms that can develop useful tools.
"We believe more and more cancer patients will be diagnosed based on a broad panel of molecular information," Parekh said, "and that patients will be treated based on their biomarker profiles and monitored for changes in their biomarker profiles and then retreated based on those changes."
Biocartis' DMAT platform is based on semiconductor technology for binding proteins and nucleic acids to the surface of a digitally encoded particle. The advantage of the technology is enhanced specificity, Parekh said. Additionally, the technology simplifies the workflow by allowing for the co-flushing of a molecule and the sample simultaneously, thus eliminating the washing step and reducing the pipetting step.
With Biocartis' first product now on the market, "I think mentally and psychologically, it puts the company in a different mindset," Parekh said. "We are thinking about customer access, we're thinking about content, we're … really moving beyond purely thinking about the next technological advance."
Based on feedback from its Platinum customers Biocartis will continue the development of the DMAT platform and make necessary tweaks. "We have ideas for a second-generation of that platform where we can drive sensitivity even further," Parekh said.
Further out the company is eyeing a 510(k) submission to the US Food and Drug Administration for the platform. Using customer feedback again, Biocartis will make the necessary changes to DMAT while simultaneously developing assays for RUO purposes as well as with an eye toward FDA submission.
Parekh said a 510(k) submission for the platform and its assays is anticipated in 2015.
"We'll have to make a decision on whether we stick with the existing version of the platform or whether we modify the platform to enhance its capabilities in one area or another," Parekh said. "And we'll make that call probably pretty soon, maybe six months into the launch. Either we'll run straight into an IVD development program or we will make a design change to the platform and then start an IVD development program."
On the assay front, while three assays are being launched immediately with the system, Biocartis has signed on "a very well-known assay development shop" to exclusively create assays for Biocartis, though Parekh declined to identify the partner or the disease areas the assays will address.
In the meantime, the company continues to develop the Apollo molecular diagnostic system that it acquired from Philips in 2010. Biocartis has been positioning the platform for the decentralized molecular diagnostics market, and Parekh said that it has achieved a "design freeze" on the instrument and its components. Next month, the company will start verification and validation of the platform.
That process is anticipated to be completed by the end of 2013, and Biocartis plans to CE mark Apollo and launch it in Europe in the first quarter of 2014. Concurrent with CE marking, the company will pursue 510(k) clearance for the system.
Biocartis is in discussions with "a couple" of drug firms for companion diagnostic development deals and Apollo may be used in 2013 for clinical trials to support such efforts, Parekh added.
In 2010, BioMérieux acquired the rights to develop microbiology assays for the platform. The following year Janssen Pharmaceutica, part of Johnson & Johnson subsidiary Janssen Pharmaceutical, licensed the rights to develop assays for the system in certain areas of central nervous system diseases and viral infectious diseases.
Additionally Biocartis is creating its own oncology assays for Apollo. An assay for BRAF mutation detection is in late-stage development while two other cancer assays are in early and mid-stage development, according to Parekh.
Today, the firm announced its €34.5 million Series D round led by Flemish investment firm PMV. Other participants included RMM (Rudi Mariën); Valiance; Debiopharm Group; Korys, the investment holding of the Colruyt family; Philips; Johnson & Johnson Development Corporation; the family office of Paul Janssen; Luc Verelst; Benaruca, the family investment vehicle of Pauwels; and New Rhein Healthcare, of which Parekh is a founding partner.
Biocartis also said that Roald Borré, representing PMV, is joining its board.