Here at Medgadget we’ve covered dozens of molecular and genetic diagnostics that utilize novel screening tools to identify disease. However, integrating these tools into the clinic is difficult: according to recent research by UnitedHealth, 77 percent of physicians say that the largest barrier to conducting genetic testing is the cost of tests for patients. Innovations cannot succeed on a large-scale unless they are affordable for patients. Thus, the push to develop lower-cost tests is more important than ever.
Enter Rheonix, Inc., a maker of molecular diagnostic equipment based in Ithaca, N.Y. Rheonix has developed the Encompass platform, a highly customizable technology that has made a point to balance versatility of tests with affordability. The platform performs fully automated, complex molecular assays on the Rheonix CARD cartridge. EncompassMDx offers automated sample preparation designed to isolate DNA and RNA from a variety of samples, including fresh tissue, formaldehyde fixed-paraffin embedded (FFPE) tissue, whole blood, serum, saliva, swabs and urine. EncompassMDx processes sample volumes from 5 µl to 5 ml, and tissue mass up to 20 mg for integrated nucleic acid testing. In terms of applications, Rheonix envisions its CARD cartridge as applicable in many settings, including the IVD lab, the pathology lab and at the point of care. The company also has product development programs for infectious diseases, pharmacogenomics and environmental applications. We had a chance to speak with Gregory Mouchka, Product Manager of Engineering & Applications at Rheonix Inc.
Ravi Parikh, MedGadget: How did Rheonix get into the field of molecular diagnostics? How has the vision of the company evolved?
Gregory Mouchka, Rheonix Inc.: Rheonix began as an internal project at a semiconductor company, Kionix Inc., in Ithaca, NY, developing novel microfluidic systems out of silicon in Kionix’s fabrication facilities. It soon became apparent that producing fluidic devices out of silicon is prohibitively expensive, so we decided to develop devices in polystyrene. Once we mastered our proprietary lamination method and active fluidic pumping technique, we were able to run molecular biological assays. From there the next logical step was to look to the clinic and molecular diagnostics. Rheonix now manufactures the EncompassMDx diagnostic instrument that performs fully automated, complex molecular assays on samples using the Rheonix CARD Cartridge.
Medgadget: What can you tell us about the current state of low-cost genetic tests? What is lacking?
Mouchka: The current genetic testing landscape is somewhat fractured. Some tests, such as prenatal screening panels, have seen wide adoption due to a large market, established reimbursement rates and physician education. Other tests, such as warfarin sensitivity testing, have been slow to adopt. This is due to a chicken-and-egg syndrome; there is a high cost of adoption because of low market demand based on lack of requests from ordering physicians or reimbursement guidance. Tests from specimens that are difficult to work with, especially Formalin Fixed Paraffin Embedded (FFPE) tissue, are so labor-intensive that they are not widely offered and have high costs associated with them.
Medgadget: And how do innovations like the EncompassMDx and accompanying CARD consumable improve upon those deficiencies?
Mouchka: Rheonix has developed the EncompassMDx instrument and the CARD consumables with these deficiencies in mind. Together they make up a platform that enables a laboratorian to automatically process samples at a cost that encourages them to bring more tests in-house rather than sending them out. Automation is a powerful tool for the laboratory: It removes repetitive tasks from technicians, and allows technicians of various tenures and skill levels to operate the equipment and obtain the same quality result. Our technology can handle a wide range of sample types, including the difficult-to-process FFPE tissue. We intend for our instrument to be a one-stop shop for running a variety of tests, with a variety of samples. The EncompassMDx can automatically run batches of up to 24 samples through cell lysis, nucleic acid purification, multiplexed PCR amplification, and endpoint target detection. Turnaround time is approximately three hours; about 2.5 hours of that time is uninterrupted walkaway time for the lab technician. All assay operations take place on Rheonix’s single-use consumables, reducing contamination and cleanup time. Our low cost of ownership and operation allows labs to continue running automated tests even in the world of shrinking budgets and reimbursements.
Medgadget: How do you envision these low-cost molecular diagnostics being applied in clinical settings? Are your products being used in the clinic now?
Mouchka: The Rheonix CARD Cartridge is constructed from laminated layers of plastic—all the fluidic valves and pumps are produced as a consequence of that lamination process. Because there are no electronics, precious metals, external sealing or pumping parts, the cost of our cartridge is very low. The low costs allow us to pass savings along to clinicians and penetrate markets where sample-to-result testing has not been available before. Though our products are not yet available for use in clinical settings, other first-generation sample-to-result molecular systems have placed instruments in clinical labs. Rheonix hopes to improve upon the existing systems by offering superior target multiplexing, cost and workflow to laboratorians.
Medgadget: What about the possibility of patient-centered use? Do we need skilled technicians to perform these interventions?
Mouchka: The technology naturally lends itself well to applications where ease of use is important. However, automated molecular devices are generally classified as “moderately complex,” requiring that doctors order tests and certified labs run them. Patient-centered use, or point-of-care testing, is a highly regulated market and rightly so, because the health and welfare of patients can depend on the results of the test.
Medgadget: Tell us about future directions of these technologies. What improvements do you envision?
Mouchka: In the near term, the direction should be wider adoption and menu expansion. We believe our scalable technology can be utilized in small community clinics, all the way up through large regional reference labs. The configurable nature of the consumable and instrument also means that as new tests are developed and deemed clinically useful, they can be easily ported over to the EncompassMDx platform.
Medgadget: Is there anything coming up in the Rheonix pipeline that we should keep our eyes open for?
Mouchka: We will have some exciting partnerships to announce in the coming year as we continue to make molecular diagnostics available to more people, in more places, more often.
Medgadget: Anything else you would like to mention?
Mouchka: Interested customers can learn more about various purchase and lease options of Research Use Only equipment by contacting Rheonix at 607-257-1242 or visiting www.rheonix.com.
This innovation from Rheonix hopefully foreshadows a trend of affordability in molecular diagnostics. We look forward to more exciting and affordable diagnostics in the future!
Poster presentation at AACC Oak Ridge Conference 2012: Evaluation of a Microfluidic System for Performance of Fully Automated Companion Diagnostics for Personalized Medicine (PDF)