By Ben Butkus
GRAPEVINE, Texas – Swiss molecular diagnostics firm Biocartis said today that it has closed a Series C financing round for €71 million ($96 million) to back the commercialization of its flagship, fully automated molecular diagnostic system and to continue developing a second, highly multiplexed platform for life science research applications.
The company expects to begin clinical trials for the molecular diagnostics platform, codenamed Apollo, in both Europe and the US next year, with an eye toward garnering regulatory approval in those parts of the world in 2013 with molecular tests for infectious disease from corporate partners such as BioMérieux.
Once commercialized, Apollo will be "quite a leap forward" because of its integrated sample prep for a wide range of specimens and its ability to conduct real-time PCR detection on five- to six-fold as many targets as most existing commercial molecular diagnostic platforms, Erik Vossenaar, director of business development at Biocartis, told PCR Insider at the Association for Molecular Pathology meeting here today.
"We feature multiple PCR chambers per cartridge, so with today's level of chemistry we can do up to 30 different targets, so that's quite a leap forward compared to something like the Cepheid system," Vossenaar said. "Of course there are systems on the market that offer that level of multiplexing, but they don't give quantitative results."
Biocartis acquired the underlying technology for the Apollo platform from Royal Philips Electronics in 2010; and the companies have since worked together to develop the system (PCR Insider, 2/11/10).
Inspired by various semiconductor technologies and design elements from the consumer electronics industry, Apollo is being designed as a compact, benchtop system comprising an instrument, communication console, and single-use, disposable cartridges.
The platform will be capable of detecting biomarkers from a wide variety of patient sample types without the need for a specialized laboratory or trained technicians; and will be able to deliver results as accurate as those generated in a clinical laboratory in as little as one hour from sample prep to readout, the company said.
One of the keys to this will be the platform's "unique combination of elements" for sample prep, which combines the well-established "Boom" method for nucleic acid purification with several innovations from Biocartis and Philips.
"The Boom chemistry itself is already quite powerful in removing inhibitors, et cetera, and concentrating nucleic acids from complex sample matrices," Vossenaar said. However, he added that these matrices are often difficult to work with, especially in systems using mesofluidic technology as does the Apollo, "and that's where the other elements of the sample prep come in, for instance, to liquefy the sample so it can be processed with the Boom chemistry."
For nucleic acid testing purposes, Apollo will use a variety of PCR detection chemistries, so long as they are based on homogenous fluorescence detection, as is the case with TaqMan or Scorpions probes.
The latest funding round, which includes existing and new investors and industrial collaborators, brings the total amount raised by Biocartis since its inception in 2007 to at least €116 million.
Biocartis raised €10 million in a Series A financing round in October 2009, prior to its deal with Philips to bring the new technology aboard. That financing round was led by Aescap Ventures, Biovest, KBC Private Equity, Advent Venture Partners, and Benaruca, the family office of founder and CEO Rudi Pauwels.
Then, in April 2010 Biocartis announced it had closed a Series B financing worth €30 million, with participation from new investors Debiopharm and J&J Development Corporation (PCR Insider, 4/8/2010). Vossenaar told PCR Insider that this financing round actually capped off around €30 million.
The Series C financing announced today included those existing investors as well as new investors the Wellcome Trust, Korys, Valiance, the family office of Paul Janssen, New Rhein Healthcare, and certain members of the Biocartis senior management team.
The new group includes some investors with a pure financial interest, and some with designs on potential collaborations with Biocartis. Of note, the Wellcome Trust "is very interested in our technology," Vossenaar said, without elaborating.
Biocartis has also been busy forging collaborations with various assay developers to ensure that once Apollo is launched it has a broad test menu available to potential customers.
For instance, Biocartis struck an agreement with BioMérieux in November 2010 to co-develop various infectious disease assays for the platform and give BioMérieux access to the system for certain oncology and theranostic assays. In July of this year BioMérieux acquired French diagnostics firm Argene in a bid to further bolster the test menu it is building for the Apollo (PCR Insider, 7/21/11).
Also, in January, Biocartis said that it had entered into a partnership with Janssen Pharmaceutica, a division of Johnson & Johnson, to co-develop molecular diagnostic assays with input from J&J's Ortho Clinical Diagnostics in the area of neurological disease and certain viral diseases (PCR Insider, 1/13/11).
Vossenaar said that the first assays to enter clinical testing will likely be from the BioMérieux partnership, and will test for infectious bacteria, and particularly hospital-acquired infections.
If all goes well, the companies expect the Apollo system and these first assays to receive regulatory approval in both Europe and the US in 2013, he added.
Biocartis is also developing a second system based on disposable, microfluidic cartridges and digitally encoded microcarriers to rapidly and sensitively detect a broad range of biomarkers – both nucleic acid and protein – primarily for life science research applications.
This platform, which was actually conceived at Biocartis prior to its partnership with Philips, will strive to achieve an even higher level of multiplexing than Apollo.
"It's not a fully integrated system like [Apollo], so it does not at the moment include sample preparation, and is more of a detection system," Vossenaar said.
"We believe that for the IVD market we need a very integrated sample-in/sample-out type of system; and for the life sciences research market we can focus a little more on higher-throughput, multiparameter analyses with a little different user interface so a customer can see each and every detail of the analysis," he added. "With our molecular diagnostic system we are really focusing on ease of use."
Further down the road, Biocartis is eyeing the development of its own molecular assay content for its testing platform, primarily in the area of pharmacogenomics.
"We have two big partners to help us develop assays, but we continue to develop our own menu," Vossenaar said. "Our dream is to facilitate personalized medicine, especially in the oncology field. We believe there is a very big opportunity for systems like ours to speed up complex molecular assays to help the patient."
He added that Biocartis has a roadmap in place for this assay-development strategy, but that it was too early to share details. "We will start with the low-hanging fruit, maybe some 'me-too' assays that are well-accepted," he said. "The AMP meeting is an excellent way to get up to speed in this area."
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