By Ben Butkus
This article was originally published on April 27.
Rheonix, an early-stage molecular diagnostics company spawned from the semiconductor manufacturing trade, came out of stealth mode last week by announcing the completion of a $12.6 million Series A financing.
The company will use the funding to continue developing its flagship product — the Rheonix "chemistry and reagent device," or CARD — which integrates sample preparation, nucleic acid amplification, and endpoint detection all on a single microfluidics-based, point-of-care polymeric module.
In addition, Rheonix has partnered with a number of companies and academic institutions to develop laboratory protocols and molecular diagnostic assays for the CARD, with the goal of submitting its first 510(k) application to the US Food and Drug Administration by the end of this year, most likely for a warfarin-sensitivity assay, President and CEO Tony Eisenhunt told PCR Insider.
A syndicate of regional and international firms, led by Cayuga Venture Fund and private investors Bill Allyn and Eric Allyn, participated in the Series A financing.
Based in Ithaca, NY, Rheonix is the offspring of a company called Kionix, which was founded out of Cornell University in 1993 to manufacture semiconductor components for a variety of industries, and in particular MEMS-based inertial sensor technology.
In the early 2000s, a small group of executives and scientists within Kionix formed a team to explore applications of the company's manufacturing know-how to life sciences applications, and in particular in vitro diagnostics, according to Eisenhunt.
"[They] quickly came to the conclusion that in the IVD market, for a widespread platform to be fully embraced and utilized, it had to be relatively inexpensive, and doing it with silicon was not a good solution," Eisenhunt said. "And although Kionix is a silicon-based manufacturing company, within a year and a half, the division [within the company] moved to polymeric platforms instead of silicon."
Rheonix became an independent operating company in December 2008, and this past November, parent Kionix was acquired by Japanese semiconductor and consumer electronics company Rohm, leaving Rheonix as "the third generation of the Kionix commercialization engine," Eisenhunt said.
Some of Rheonix's intellectual property was originally developed at Cornell, but the bulk of the manufacturing know-how was developed at Kionix and now resides with Rheonix, which has assembled and developed "a very comprehensive IP portfolio around how we manufacture and assemble CARD, and the fluidics behind the operation of our platform," Eisenhunt said.
The CARD platform, Rheonix's flagship product, allows a variety of molecular assays to be performed on a single, modular platform that includes raw sample preparation and broad, multiplex analysis capabilities.
Because it is polymer-based, "the cost of materials and ultimately our ability to integrate various components onto the platform is relatively straightforward and cost-effective," Eisenhunt said.
And although it can be customized to perform almost any assay that is normally done on the bench top — such as immunoassays, pathogen identification, gene sequence detection, and cell-based assays — Rheonix is focusing primarily on developing the CARD platform for nucleic acid amplification-based molecular diagnostic assays.
Describing the CARD platform, Eisenhunt said that it integrates traditional PCR tubes into a device akin to "a bi-layered credit card, where there is a bottom layer … and a cap layer that goes on top to make it a fully contained system."
All amplification-based assay components, including raw sample prep, rapid thermocycling, and detection, are self-contained in the module. "It seems to be one of the points that surprises people," Eisenhunt said. Often times the question is asked, 'OK, once you have the aliquot from your PCR, where do you move it?' And we don't move it. It's all done on CARD, fully integrated."
Rheonix has conducted in-house experiments using "traditional PCR" protocols on CARD, as well as a technique called nucleic acid sequence-based amplification, or NASBA, which forms the basis of BioMérieux's NucliSENS EasyQ amplification kits.
Eisenhunt said that Rheonix has partnered with various companies "to take a protocol that they have at the lab bench and integrate it into our CARD in anywhere from a two- to four-month timeframe, to show the robustness and breadth and applicability of our platform." He declined to disclose any partner companies, citing confidentiality agreements.
Meantime, Rheonix is also developing several in vitro diagnostic assays for the CARD platform. First and foremost of these is an assay for detecting warfarin sensitivity in patients. "This will probably be first to market, because of the depth of work that's been done already, and the path to market," Eisenhunt said, adding that Rheonix plans to file a 510(k) application for the test before the end of this year.
In addition, Rheonix has a clinical collaboration in place with a National Institutes of Health-funded consortium comprising Lehigh University, New York University, Leiden University, and the University of Pennsylvania, focused on HIV detection; and a collaboration with an undisclosed Chinese company for HPV detection. Rheonix is also working on a sepsis assays for the CARD system.
All of these assays should be amenable to the point-of-care market, Eisenhunt said, because of the ability to prepare raw samples directly on CARD. For instance, the HPV assay will begin with a vaginal swab placed directly into solution on CARD, "and literally the entire process is automated from that point all the way through endpoint detection," Eisenhunt said. Similarly, the company has used both buccal swabs and raw blood as the starting point for the warfarin sensitivity assay.
Although molecular diagnostics is currently Rheonix's main focus, it is also developing the CARD platform for applications such as detection of water- and food-borne pathogens and ELISA-based assays for avian influenza detection, Eisenhunt said.
"We continue to look at potential platforms and talk to partners about applying our platform to protocols and assays that they are interested in automating," Eisenhunt said.