Simplicity by design—ensuring usability in decentralized point-of-care settings—is the value proposition of a platform technology poised for a U.S. market launch in 2013.
|Diarmuid Flavin, CEO of Biosensia, has 15 years of management experience in the healthcare industry, from diagnostics to medical devices and sterile parenteral pharmaceutical manufacture. Previously, he was quality operations manager for cardiac therapies at Abbott Vascular. Flavin is a graduate of the National University of Ireland and holds an MSc in pharmaceutical manufacturing technology, a higher diploma in QA assurance, and a BSc in microbiology.|
Irish startup Biosensia will bring its RapiPlex point-of-care (POC) IVD platform technology to the 2012 AACC Annual Meeting in the hopes of finding some eligible suitors. The system combines ease of use with rapid, cost-effective deployment in almost any environment. The company hopes to have the technology on the market in the United States by the first quarter of 2013. IVD Technology had a chat with CEO Diarmuid Flavin as he was getting ready to head for Los Angeles to exhibit at the AACC event.
IVD Technology: You presented a couple of posters at the AACC Oak Ridge Conference in San Jose, CA, in April proving the effectiveness of your RapiPlex platform. For the benefit of those who were unable to attend the event, can you explain the technology behind your product?
Diarmuid Flavin: The posters at the AACC Oak Ridge Conference showed how RapiPlex, our point-of-care IVD platform, is ideally suited for a variety of diagnostic assays. At Oak Ridge, we showcased how RapiPlex could be used in two POC settings.
First, we demonstrated RapiPlex’s effectiveness in detecting drugs of abuse in saliva and urine, illustrating how RapiPlex can be used for drug testing or, indeed, other small-molecule assays in a variety of point-of-care usage settings.
The second poster showed how RapiPlex could be used for the detection of protein cardiac markers in a small blood sample, making it ideal for rapid cardiovascular assays, ensuring a patient receives immediate effective treatment.
Biosensia’s platform comprises a multiplex disposable cartridge that is analyzed on a universal touch screen reader. A key element of the system design is its simplicity of use, which ensures its successful operation in a variety of decentralized point-of-care settings. A sample, which can be anything from a very small volume of whole blood to a very large volume of urine or saliva, is taken from the patient and applied to the cartridge, which is then inserted into the instrument. RapiPlex can be used by semiskilled or untrained users with minimal risk of error, and the cartridge can be adapted to quantitatively measure up to 12 analytes simultaneously in less than 15 minutes.
The posters presented at Oak Ridge demonstrate the key features of the RapiPlex technology.
Flexibility was a key objective in the development of this technology, wasn’t it?
Yes, a key consideration was the ability to deploy it quickly and cost effectively in a range of POC environments. The technology is truly platform in nature and was designed for rapid use in almost any environment across a range of biological samples and sample sizes.
Biosensia is now seeking to partner and collaborate with companies that have novel biomarkers or that have existing biomarkers on other platforms and wish to transition those biomarker products to a multiplex POC platform.
I understand that the application of user-centered design principles was also a priority.
Point-of-care devices need to be intuitive. There are many historical examples of products that were fantastic in terms of performance, but were unsuccessful because of inadequate consideration of end-user requirements. This is especially true of instrumentation-based POC technologies. Throughout the design and commercialization of the RapiPlex platform, Biosensia invested time and effort in user-group studies and usage environment studies to formulate design inputs for the product design. These inputs were a key element in the design and usability of the cartridge, reader, and graphic user interface.
What were some of the significant hurdles you had to overcome in developing this platform?
One key design goal was to make the test method and user interaction as simple as possible, with minimal test intervention required by the user, while ensuring that the quality of the assay result was comparable to central laboratory outcomes. In order to achieve this, significant design effort was undertaken to integrate the assay complexity into the system while ensuring a minimal footprint and low cost of goods.
The RapiPlex system has a very simple workflow: add the sample and wait for the result to be displayed. All elements of the assay are automated. This level of simplicity from a user point of view is critical to ensure market adoption and penetration of the pharmacy/clinic/doctor’s office market, where future POC testing will see significant growth. In achieving these goals, we believe our RapiPlex platform offers the IVD community a fantastic opportunity to capitalize on forecast double-digit growth in POC testing.
I understand that you plan to move to full commercialization in 2013. Will you be going into a specific market first? What do you see as challenges in that phase?
We first plan to commercialize RapiPlex in the United States and to file a 510(k) application with FDA by the end of this year; we aim to have the device and test approved by the first quarter of 2013. At the same time, we will also file for a CE mark in Europe. While the POC market is more developed in the United States, we still see considerable potential in Europe.
What are the key differentiators of the RapiPlex technology?
RapiPlex has a number of advantages compared with other products in the POC market. RapiPlex’s inherent ability to use a wide variety of sample sizes from a small finger prick of blood to a large sample of urine or saliva without any requirement by the user to manipulate the sample is a significant user-focused advantage.
In addition, its multiplexing capability means it can run up to 12 analytes simultaneously, providing highly accurate results in less than 15 minutes. These advantages combined with a low-cost cartridge, compact and convenient benchtop reader, and central lab performance provide a compelling proposition to the marketplace.
Tell us about the origins of your company.
Biosensia was established in Dublin in 2008. Our objective in setting up the company was to develop a universal-application POC platform technology on which a full point-of-care business could be created. The technology was not licensed but rather developed in house, and Biosensia has continued to add to and expand its IP portfolio. The company is venture capital funded and we have a number of Irish VCs backing us. Enterprise Ireland, the government agency, also supports Biosensia.
Can you give us an update on the state of the IVD industry in Ireland? How has it been affected by the economic downturn?
While Ireland has been heavily affected by the economic downturn at a fiscal level, the life sciences industry has remained strong. We completed a fundraising in November and there are other examples of life science firms in Ireland that have successfully raised funds in recent times, which points to a reasonably robust funding environment within Ireland.
We also continue to see growth in the industry here in Ireland, with significant government investment in university-based research by Enterprise Ireland and Science Foundation Ireland. An example of this is the Biomedical Diagnostics Institute at Dublin City University, which performs world-class research in IVD technologies. Despite the downturn, the government continues to invest in IVD R&D and life sciences in general, which, in turn, fosters a healthy start-up culture. The combination of this R&D infrastructure, a robust start-up culture, and the manufacturing presence of eight of the top 10 pharma companies and 15 of the top 25 medical device companies makes Ireland a fantastic place to do life sciences business right now.
From your vantage point, how would you characterize the future of POC diagnostics?
I believe POC diagnostics is at an inflection point. There are several fundamental drivers underlying the trend.
From a technology point of view, advances in integrated POC multiplex detection technologies combined with the emergence of novel biomarkers facilitating multimarker analysis of disease states allow the delivery of products that can be used in decentralized usage environments.
On the user side, we are now beginning to see a desire from nontraditional users, such as pharmacies, to adopt POC technology.
Add to this a general trend toward a more informed public taking control of its health, and I believe we will see more adoption of POC testing trending toward multimarker analysis.