Courtagen Life Sciences said this week that it has submitted a pre-investigational device exemption information package to the US Food & Drug Administration for its Avantra Q400 Biomarker Workstation and QPDX BioChip for the measurement of C-reactive protein.
The submission is part of the company's preparation for its planned 510(k) filing and EU CE mark application for the device and CRP assay. According to Courtagen CEO Brian McKernan, the company hopes to receive FDA approval for the CRP assay sometime in 2013, at which point it will bring the test to market.
McKernan also told ProteoMonitor this week that the company plans to launch a funding round at the end of June to raise money to support this and other initiatives. The round "will be at least $15 million," he said, adding that "depending on some of the corporate initiatives that we are looking at right now and some potential acquisitions, it may be much higher than that."
Courtagen was launched as Avantra Biosciences in December 2009 from the assets of defunct biomarker firm Decision Biomarkers (PM 7/23/2010). The company launched the Q400 as a research-only device in January 2011 along with its Angio Qx BioChip immunoassay for the study of tumor vascularization (PM 1/28/2011).
The Q400 system consists of an assay-processing and fluorescence-imaging platform and disposable biochips that contain all the reagents required for performing multiplex biomarker assays. The platform generates results in 15 minutes to 30 minutes with coefficiencies of variation of under 10 percent and requires no sample prep, McKernan said, suggesting that this makes it ideal for point-of-care and near-point-of-care applications.
"You basically insert blood into a buffer in the biochip, hit a button, walk away, and you get your answer in 15 to 30 minutes depending on your required sensitivity levels," he said. "The challenge for most immunoassays, [particularly] when you are running them multiplexed, is it requires a fair amount of manual or automated prep. We've eliminated all that by putting all the required agents – capture and detection antibodies, fluorescent probe, buffer, sample – in the biochip, so the user doesn't have to worry about the array.
The system is capable of multiplexing up to 20 analytes on a chip. However, McKernan said, thus far the company has found that most collaborators are interested in lower levels of multiplexing.
"Most of the people we've talked to are interested in three to seven analytes," he said. "Any more than that tends to be a little bit overwhelming with respect to the amount of data they have to interpret and analyze."
McKernan said that the company was able to mitigate the problem of antibody cross-reactivity – typically an issue with multiplexed immunoassays – by optimizing any assays run together on the platform.
"It's not an open system," he said. "User[s] can't go and make their own biochips. They have to call us, let us know what type of analytes they would like in the chip, and then we build a prototype. And in that prototype phase we work through those cross-reactivity issues to make sure that there are none."
McKernan said the company chose CRP as the first protein assay to take through FDA due to the existence of numerous equivalent CRP assays on the market and the use of the protein as a biomarker in a variety of conditions.
The company's assay is "fundamentally an equivalence assay for what is out there for CRP right now in terms of sensitivity levels, CVs, things like that," he said. "CRP has popped up in a lot of our discussions [with collaborators] and there happen to be predicate devices out there. So we thought it would be good to start with. We could move it through FDA and get our partners comfortable, show that this was the real deal, that this technology can go point-of-care."
McKernan said the company plans to generate data on the test over the next six months and then prepare its 510(k) submission. He noted that the company doesn't currently know what level of trial work FDA will require but said that he expects to provide data from "several thousand biochips." The company plans to use a significant amount of this data for its CE mark application, as well.
Beyond CRP, Courtagen is exploring use of the platform for research and clinical work in several areas, including radiation sickness and bioterrorism. In February the company announced a collaboration with Avaxia Biologics to create an assay for use in developing an antibody therapy to mitigate the gastrointestinal damage caused by radiation exposure (GWDN 2/29/2012). It is also involved in talks with a drug maker to develop an assay for monitoring patient response to a sepsis therapy, McKernan said.
Courtagen has also branched out into genomics research, acquiring in January Medicinal Genomics, where Kevin McKernan, Brian McKernan's brother, was founder and CEO (GWDN 1/18/2012).
The company has a CLIA-certified laboratory out of which it is currently providing its mtSEEKPD product, a clinical next-generation sequencing test for patients with mitochondrial disease. It plans to complement this test with proteomic data, McKernan said, noting that the company has licensed a number of protein markers for mitochondrial disease "that we are putting onto our chips right now … and running those biochips in concert" with their sequencing assays.
"Sequencing is a great tool, but it's not a silver bullet," he said, explaining the company's drive to include proteomic data with its genomic tests. "There will be times where you find a signature in the genome that could be highly informative as to a patient's condition, but more than likely that won't be the only piece of information you have to take into consideration."