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MyCartis Plans to Launch System, Kit Next Month in Bid to Combine Multiple Levels of Omics Data

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NEW YORK (GenomeWeb) – Recently launched Biocartis-Pronota joint venture MyCartis is taking aim at the multi-omics space, looking to combine genomic, transcriptomic, and proteomic analyses for the development of research and clinical products.

At the center of this effort is the new firm's Evaluation platform, a multiplex system for rapid detection of protein and nucleic acid biomarkers. According to former Pronota CEO Katleen Verleysen, the company plans to launch the platform along with a cardiac biomarker research panel this October at the 2014 Human Proteome Organization annual meeting in Madrid.

Verleysen told ProteoMonitor this week that she stepped down as Pronota CEO upon formation of the new venture, noting that with the deal Pronota has ceased to operate as an independent entity. MyCartis' CEO is Paul Ladestein, who joined Biocartis in 2013 as Evaluation business unit manager after working for Luminex.

The decision to form the new company, Verleysen said, stemmed from business transitions at both Biocartis and Pronota. In the case of Biocartis, she said, the company was looking to spin out its Evaluation platform so that it could concentrate on its Idylla molecular diagnostics system. Biocartis this week announced that it has obtained CE-IVD marking for and commercially launched the Idylla platform and its BRAF Mutation Test for use on the platform.

For Pronota, the joint venture was a way to continue development of its protein biomarker panels, particularly those for cardio-renal diseases and preeclampsia, Verleysen said.

"We came to a point where we had [these] two programs validated, and we were ready to take the next step and take these products to market," she said. "But that was going to require at least an additional €10 million ($13 million), as well as a [diagnostic] platform to port that content onto. So, we went out not only to fundraise but also to see if there was a platform suitable to translate our content onto."

Pronota was, in fact, "extremely close" to merging with a California-based molecular diagnostics firm, Verleysen said, though she declined to identify the company by name.

However, "in the final step there were some issues where both companies' investors couldn't see eye to eye and that was really the end of that merger," she said.

And so, Verleysen said, Pronota began looking closer to home, ultimately striking a deal with Mechelen, Belgium-based Biocartis. MyCartis will be headquartered at Pronota's offices in Ghent but will also maintain an office in Ecublens, Switzerland, where the Evaluation platform was developed.

BioCartis is the main shareholder in MyCartis, which last week said it had completed a financing round of €15 million with investments from RMM, Valliance, and Biover II.

No Pronota investors have backed MyCartis yet, Verleysen said. She noted that there was a second round planned in which Pronota investors might participate. However, she said, Pronota's lead investors, LSP and Gimv, do not plan to invest in the new venture. Other past Pronota investors include Biotech Fund Flanders, KBC Private Equity, Johnson & Johnson Development Corporation, VIB, MP Healthcare, and MedSciences Capital.

In addition to Pronota's protein biomarker assets, MyCartis has in-licensed RNA-based cardiac markers with the aim of combining multiple levels of omics measurements on the Evaluation platform.

Calling tests combining genomic, transcriptomic, and proteomic data the "future of molecular diagnostics," Verleysen said that MyCartis aimed to demonstrate through this cardiac work the ability of the Evaluation platform to combine such assays.

"You have interesting DNA or RNA panels and interesting protein panels, but [few people] have really looked at the impact of … combin[ing] all these panels together," she said. "And if you start to run clinical experiments in that fashion, in the end you need an instrument that allows you to run these things in this way, and Evaluation is a platform that can handle that."

MyCartis' HUPO launch will consist of the Evaluation platform and a combined RNA-protein assay intended for academic and clinical research, Verleysen said. "The initial focus is the life sciences research market and the clinical research market ... more about academic centers, laboratories, pharmaceutical companies."

She said that the company is also planning a clinical study of the RNA-protein cardiac panel.

A panel featuring Pronota's preeclampsia markers will follow sometime after the launch of the cardiac panel, she said. She added that Pronota's sepsis markers – the company's other main area of focus – had been sold to Biocartis as part of the joint venture agreement.

While the Evaluation platform detects proteins via immunoassay, Pronota has traditionally used mass spec for protein biomarker discovery and validation. These capabilities will continue to exist within the new company, but MyCartis is for now focused on commercializing the existing cardiac and preeclampsia panels, she said.

"With only €15 million [in funding], you have to be realistic," she added. "They have, I would say, almost more than they can chew. So, I would say in the beginning the main focus will be the launch of the system and launch of the cardiac panel, followed by preeclampsia. We have that [mass spec] discovery capability that will allow them to broaden the [assay] menu, but that is not on the agenda for the short term."

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