By Tony Fong
NEW YORK (GenomeWeb News) – Established diagnostics firms such as Roche and Abbott can have the batch processing market, as far as Biocartis is concerned. The Swiss-based start-up has its eyes on the decentralized molecular diagnostics space.
In February, Biocartis acquired Royal Philips Electronics' molecular diagnostic platform, and is now in the process of building it out in expectations of a late-2012 launch.
While systems such as Roche's Cobas and LightCycler platforms and Abbott's m2000 platform have become workhorse instruments for molecular testing, Biocartis seeks to address a market that doesn't always need large numbers of samples being run every day or every hour, but rather, requires a system that can perform smaller numbers of tests, or even a single test as soon as a biological sample is drawn or received.
For smaller to mid-sized laboratories, especially, Biocartis' platform would provide entry into the molecular testing space, CEO Rudi Pauwels told GenomeWeb Daily News. In addition, he said, the platform would have use in a clinical environment since test results can be achieved quickly without the need for a trained molecular biologist.
Pauwels was opaque on details about the platform because it is still in development, but said that it employs amplification technology and is being developed for use on a variety of sample types, including blood, urine, sputum, tumor tissue, and feces. The goal is to decentralize molecular diagnostics testing without sacrificing accuracy in test results.
"The whole rationale of Biocartis is to bring testing in a form that is very easy to use," Pauwels said. "So that's our objective, to lower the barrier [for adoption of] very advanced molecular diagnostics testing."
He stressed that Biocartis' platform will not compete with or replace systems such as Abbott's or Roche's. Rather, it is for random-access testing, meaning that once a sample comes in, testing can be done immediately.
"You don't have to batch it with other samples," Pauwels said.
The platform is fully electronic and does not contain tubes or bottles or other material found in traditional lab equipment, eliminating the need for decontamination. "It means the platform is capable of being placed in less sophisticated settings, so you systemically get away from the typical high-calibration laboratory maintenance-intensive devices," Pauwels said.
While PCR-based methods are an obvious use of the platform, it can also employ other amplification methods such as isothermal techniques, and it can perform DNA and RNA testing, as well as methylated DNA testing. Depending on the complexity of the sample type, results can be retrieved in as little as 45 minutes, according to Pauwels.
Now in its third iteration, the system consists of a console that works as a two-way communication device linking "the setting where the test is performed" to a facility such as a laboratory, hospital, or doctor's office. Testing is done in the instrument component of the system where cartridges containing generic consumables are run against biological samples.
The prototype work for the platform has been finished, Pauwels said, and Biocartis, along with Philips, is in the industrialization, verification, and validation phases of developing the system.
According to Pauwels, Philips remains "very closely involved" in the continuing development of the platform, especially on the instrument side. Along with making sure that the hardware, the cartridges, and the initial applications are working correctly in what is expected to be the launch version of the platform, the two companies are mapping out how the instrument and consumables will be manufactured, he said.
Because Philips had spent about five years developing the platform, integrating new elements into it along the way, it and Biocartis are at the fine-tuning stage to ensure that test results are reproducible across different labs and settings, that they are consistent, and that they are robust.
The two firms are also expanding the range of applications to include more samples types and increase the platform's sensitivity and speed.
"What we are especially changing is … the way that it looks, certain parts of the pumps, the architecture … and, of course, the application work," Pauwels said.
Seeing Advantages in a Competitive Market
A few other fully integrated random-access systems are either on the market or are being developed by companies such as Cepheid and Becton Dickinson. Also, Iquum has an instrument called the Liat Analyzer on the market, TS Biosystems is developing a point-of-care platform, and Enigma Diagnostics is reviewing the dates for the launch of its platform, called the Enigma ML, a spokeswoman said.
According to Pauwels, Biocartis' system can process a wider range of sample types and has a greater number of parameters that can be tested at any given time.
Though a launch is still two years away and the platform doesn't yet even have a name, Biocartis is laying down the commercialization groundwork by targeting deals that not only will build out applications for the system, but will create adoption opportunities when it is launched.
Earlier this month, it announced a deal with French microbiology and diagnostics firm BioMérieux for the co-development of assays on the Biocartis platform. The deal provides Biocartis with a €9 million ($12.2 million) investment, in return for a stake in the company for BioMérieux, as well as upfront and royalty payments. Equally important, the deal gives Biocartis access to a customer base it might not otherwise have.
The deal is the first of what Pauwels said will be similar ones expected to be announced throughout 2011.
Because of BioMérieux's expertise, the first test being developed by Biocartis for the system is directed at microbiology with an emphasis on tests for hospital-acquired infections.
In addition to providing the first applications to the platform, the partnership brings with it a distribution mechanism, "which I think is very important when you introduce a new platform," Pauwels said. "It's important that when you innovate that you can bring that innovation in a relatively short time to market."
That is a lesson that has tripped up other start-ups, such as Signal Diagnostics, which originally targeted Third World countries for its amplification technology, but has now had to rewrite its strategy after being unable to penetrate that market.
The BioMérieux deal is a pivotal event for Biocartis, Pauwels said, because BioMérieux has experience marketing to the microbiology medical community.
"That is very good for us. We do not have to reinvest time and waste energy and money," to crack that market, Pauwels said. "By building such a partnership, we're bringing what we believe is an exciting platform to a company that has the knowledge, and the financial [resources], and IP, and the know-how to bring those assets" to play.
That approach and his background co-founding Tibotec, Virco, and Galapagos Genomics has allowed Biocartis to raise more than €50 million in the past 12 months in a funding environment that has been lukewarm to the life sciences and molecular diagnostics spaces.
While there is a general recognition that molecular diagnostics could usher in a new era of healthcare, many new firms in the space have stumbled because they were unable to translate their ideas and vision to commercial implementation, Pauwels said.
"It's one thing to talk about a new technology, but turning that into real processes, real products, for example, the industrialization [of the products], I think that's where a lot of younger start-up companies are struggling," he said. "Often [there's] an underestimation of the effort it takes to really turn that concept into a product."
Pauwels added that Biocartis is in discussions with an undisclosed drug maker to develop companion diagnostics as well as other companies to develop disease assays. Biocartis is not a research firm, though, and its strategy is to partner with companies that have developed and validated biomarkers and that are looking to partner to bring those biomarkers to clinical reality.
Before it launches the Philips platform, the company expects to announce deals aimed at diseases that PCR-based tests have targeted, such as human papillomavirus, hepatitis C, tuberculosis, and the flu. Pauwels, who has a background in infectious disease, added that such diseases are "very high on our list because there's simply a need for that."
Biocartis, which has about 40 employees at its headquarters in Lausanne, Switzerland, and a subsidiary in the Netherlands, plans to eventually submit the system for clearance from the US Food and Drug Administration and for CE marking.
In addition to the technology acquired from Philips, the firm continues developing its own original molecular diagnostics platform on which the company was founded in 2007 by Pauwels, Philippe Renaud, and Nader Donzel. That system is for quantifying and amplifying DNA, RNA, and proteins. Most of the work is currently aimed at increasing its plexing capability, Pauwels said.
No decision has been made as to when it will go to market, but the plan is to market that system for proteomics applications. Along with the launch of the Philips-developed platform, "we can cover the entire space of biomarkers," Pauwels said.