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News Article | February 21, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Nativis Inc., a clinical stage life science bio-electronic company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced that Dr. Una Ryan has been appointed to its board of directors effective immediately. Ryan is a biologist and seasoned healthcare executive with extensive experience serving on the boards of public, private and non-profit companies. She is currently a limited partner at Breakout Ventures, Managing Director of Golden Seeds, an investment firm empowering women entrepreneurs, and a partner in Astia Angel, investing in women-led ventures. Ryan currently serves on the boards of AMRI, a global contract research and manufacturing company and RenovoRx, a medical device company. She was previously the President and CEO at Diagnostics for All, Inc., a developer of inexpensive diagnostic tools for global health and agriculture; Waltham Technologies, a cleantech start-up; and AVANT Immunotherapeutics Inc. (now Celldex), a company developing vaccines for cancer and global health. Throughout her career, Ryan has successfully translated science into successful businesses, driving growth and overseeing multiple M&A’s in order to create robust and diverse organizations. Ryan spent more than 20 years as a Professor of Medicine at the University of Miami, Washington University, St. Louis and Boston University where she conducted research on vascular biology. She holds a Ph.D. in Cellular and Molecular Biology from Cambridge University and BS degrees in Zoology, Microbiology and Chemistry from Bristol University. She received an Honorary Doctor of Science degree from Bristol University in 2009. “We are thrilled to be able to continue to diversify our board of directors and welcome Una, a distinguished entrepreneur, biologist and healthcare executive,” said Nativis CEO Chris Rivera. “Una brings a broad range of experience in the life science and investment arenas to the board, and her insight will be of great value to Nativis as we continue to develop and seek long term partners for of our novel ulRFE technology. Una’s background in global health and developing medical technologies adds significantly to the diversity of our other Directors’ extensive industry experience, which includes, for example; cyber-security, disruptive technologies, financial management, venture capital and bio-pharmaceutical development.” Ryan added, “I am excited to join the Nativis team, and look forward to helping guide the company through the development of its unique technology platform. Nativis’ ulRFE technology represents an unprecedented opportunity to advance a new wave of treatment for recurrent glioblastoma multiforme and other health care indications, and I believe that with the right resources and strategies, the company can position itself for future success.” Founded in 2002 and headquartered in Seattle, WA, Nativis is a clinical-stage bio-electronics company. Nativis has invented and patented a groundbreaking technology that utilizes precisely targeted, ultra-low radio frequency energy (ulRFE™) to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-invasive device called Nativis Voyager®. The company’s goal is to transform disease treatment on a global scale with ulRFE that can potentially be applied to a wide range of conditions and other health-related needs (including agriculture, bio-fuels and veterinary medicine, to name a few). Nativis’ initial focus is on the treatment of patients with brain cancer (initially, recurrent glioblastoma), who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Additional pre-clinical work is being completed for melanoma, lung cancer, liver cancer, inflammatory disease and chronic pain.


Pollock N.R.,Beth Israel Deaconess Medical Center | Pollock N.R.,Boston Childrens Hospital | Colby D.,Beth Israel Deaconess Medical Center | Colby D.,Harvard University | Rolland J.P.,Diagnostics For All
Clinical Gastroenterology and Hepatology | Year: 2013

There is currently great need for high-quality, low-cost, point-of-care diagnostics that can benefit patients in resource-limited settings and correspondingly growing interest in the diagnostic utility of microfluidic platforms that are based on paper. We describe the development, early clinical testing, and potential clinical impact of a novel paper-based, multiplexed microfluidic assay designed for rapid, semiquantitative measurement of aspartate aminotransferase and alanine aminotransferase in a fingerstick specimen. This device ultimately holds promise for providing universal access to affordable point-of-care screening for drug-induced liver injury in resource-limited settings and opens the door to development of similar point-of-care clinical assays for other important analytes. © 2013 AGA Institute.


Rolland J.P.,Diagnostics for All
International Conference on Digital Printing Technologies | Year: 2012

Novel technologies are needed to address the urgent healthcare requirements of patients in the developing world and other resource-limited settings. Diagnostic devices that provide critical patient information at the point of need play a key role in the treatment and monitoring of disease. Such devices must be robust, simple to use, actionable, and extremely low in cost. Paper and other porous media provide an attractive platform from which to build devices that are able to address these needs. In an effort to expand the capabilities of porous media in diagnostics, we present a novel platform based on patterned paper microfluidic devices. In particular, 3-dimensional devices formed by stacking multiple layers of patterned paper provide the ability to perform many fluidic handling operations including: filtration; splitting; mixing; incubation; capture; and separations. Diagnostics For All (DFA) is developing tests based on this platform, in order to provide highly-functional diagnostic devices at unprecedented low cost. In this presentation, we will describe some specific examples of paper-based tests designed specifically for use in resource-poor areas.


Schonhorn J.E.,Diagnostics for All | Fernandes S.C.,Tufts University | Rajaratnam A.,Tufts University | Deraney R.N.,Diagnostics for All | And 3 more authors.
Lab on a Chip - Miniaturisation for Chemistry and Biology | Year: 2014

Diagnostic assays can provide valuable information about the health status of a patient, which include detection of biomarkers that indicate the presence of an infection, the progression or regression of a disease, and the efficacy of a course of treatment. Critical healthcare decisions must often be made at the point-of-care, far from the infrastructure and diagnostic capabilities of centralized laboratories. There exists an obvious need for diagnostic tools that are designed to address the unique challenges encountered by healthcare workers in limited-resource settings. Paper, a readily-available and inexpensive commodity, is an attractive medium with which to develop diagnostic assays for use in limited-resource settings. In this article, we describe a device architecture to perform immunoassays in patterned paper. These paper-based devices use a combination of lateral and vertical flow to control the wicking of fluid in three-dimensions. We provide guidelines to aid in the design of these devices and we illustrate how patterning can be used to tune the duration and performance of the assay. We demonstrate the use of these paper-based devices by developing a sandwich immunoassay for human chorionic gonadotropin (hCG) in urine, a biomarker of pregnancy. We then directly compare the qualitative and quantitative results of these paper-based immunoassays to commercially available lateral flow tests (i.e., the home pregnancy test). Our results suggest paper-based devices may find broad utility in the development of immunoassays for use at the point-of-care. © The Royal Society of Chemistry 2014.


Rolland J.P.,Diagnostics for All
MRS Bulletin | Year: 2013

Paper, broadly defined as thin, porous sheets, is currently being used to create novel devices for diagnostics, microfluidics, and electronics that ideally combine low cost and high performance. A device, in this context, can be defined as an object that serves to provide information or function to a user in response to input. This issue will highlight some of these novel devices and provide examples of potential applications. We begin with an overview of paper's unique properties and how these properties lead to a potential for changing the integrated microfluidic and flexible electronics landscape. We then discuss methods for patterning paper as well as specific fluidic operations that are possible on paper. Finally, we conclude with an overview of electronic devices on paper and a brief outlook on the future of this emerging field. © 2013 Materials Research Society.


Connelly J.T.,Diagnostics For All | Rolland J.P.,Diagnostics For All | Whitesides G.M.,Harvard University
Analytical Chemistry | Year: 2015

Clinical tests based on primer-initiated amplification of specific nucleic acid sequences achieve high levels of sensitivity and specificity. Despite these desirable characteristics, these tests have not reached their full potential because their complexity and expense limit their usefulness to centralized laboratories. This paper describes a device that integrates sample preparation and loop-mediated isothermal amplification (LAMP) with end point detection using a hand-held UV source and camera phone. The prototype device integrates paper microfluidics (to enable fluid handling) and a multilayer structure, or a "paper machine", that allows a central patterned paper strip to slide in and out of fluidic path and thus allows introduction of sample, wash buffers, amplification master mix, and detection reagents with minimal pipetting, in a hand-held, disposable device intended for point-of-care use in resource-limited environments. This device creates a dynamic seal that prevents evaporation during incubation at 65°C for 1 h. This interval is sufficient to allow a LAMP reaction for the Escherichia coli malB gene to proceed with an analytical sensitivity of 1 double-stranded DNA target copy. Starting with human plasma spiked with whole, live E. coli cells, this paper demonstrates full integration of sample preparation with LAMP amplification and end point detection with a limit of detection of 5 cells. Further, it shows that the method used to prepare sample enables concentration of DNA from sample volumes commonly available from fingerstick blood draw. © 2015 American Chemical Society.


Dunn S.S.,University of North Carolina at Chapel Hill | Tian S.,University of North Carolina at Chapel Hill | Blake S.,Massachusetts Institute of Technology | Wang J.,Baylor College of Medicine | And 8 more authors.
Journal of the American Chemical Society | Year: 2012

A critical need still remains for effective delivery of RNA interference (RNAi) therapeutics to target tissues and cells. Self-assembled lipid- and polymer-based systems have been most extensively explored for transfection with small interfering RNA (siRNA) in liver and cancer therapies. Safety and compatibility of materials implemented in delivery systems must be ensured to maximize therapeutic indices. Hydrogel nanoparticles of defined dimensions and compositions, prepared via a particle molding process that is a unique off-shoot of soft lithography known as particle replication in nonwetting templates (PRINT), were explored in these studies as delivery vectors. Initially, siRNA was encapsulated in particles through electrostatic association and physical entrapment. Dose-dependent gene silencing was elicited by PEGylated hydrogels at low siRNA doses without cytotoxicity. To prevent disassociation of cargo from particles after systemic administration or during postfabrication processing for surface functionalization, a polymerizable siRNA pro-drug conjugate with a degradable, disulfide linkage was prepared. Triggered release of siRNA from the pro-drug hydrogels was observed under a reducing environment while cargo retention and integrity were maintained under physiological conditions. Gene silencing efficiency and cytocompatibility were optimized by screening the amine content of the particles. When appropriate control siRNA cargos were loaded into hydrogels, gene knockdown was only encountered for hydrogels containing releasable, target-specific siRNAs, accompanied by minimal cell death. Further investigation into shape, size, and surface decoration of siRNA-conjugated hydrogels should enable efficacious targeted in vivo RNAi therapies. © 2012 American Chemical Society.


Pollock N.R.,Beth Israel Deaconess Medical Center | Rolland J.P.,Diagnostics for All | Kumar S.,Diagnostics for All | Beattie P.D.,Diagnostics for All | And 6 more authors.
Science Translational Medicine | Year: 2012

In developed nations, monitoring for drug-induced liver injury through serial measurements of serum transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] in at-risk individuals is the standard of care. Despite the need, monitoring for drug-related hepatotoxicity in resource-limited settings is often limited by expense and logistics, even for patients at highest risk. This article describes the development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semiquantitative measurement of AST and ALT in a fingerstick specimen. Using 223 clinical specimens obtained by venipuncture and 10 fingerstick specimens from healthy volunteers, we have shown that our assay can, in 15 min, provide visual measurements of AST and ALT in whole blood or serum, which allow the user to place those values into one of three readout "bins" [<3x upper limit of normal (ULN), 3 to 5x ULN, and >5x ULN, corresponding to tuberculosis/HIV treatment guidelines] with >90% accuracy. These data suggest that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings.


Wong S.Y.,Boston University | Cabodi M.,Boston University | Rolland J.,Diagnostics for All | Rolland J.,Carbon3D | Klapperich C.M.,Boston University
Analytical Chemistry | Year: 2014

We report the first demonstration of using heat on a paper device to rapidly concentrate a clinically relevant analyte of interest from a biological fluid. Our technology relies on the application of localized heat to a paper strip to evaporate off hundreds of microliters of liquid to concentrate the target analyte. This method can be used to enrich for a target analyte that is present at low concentrations within a biological fluid to enhance the sensitivity of downstream detection methods. We demonstrate our method by concentrating the tuberculosis-specific glycolipid, lipoarabinomannan (LAM), a promising urinary biomarker for the detection and diagnosis of tuberculosis. We show that the heat does not compromise the subsequent immunodetectability of LAM, and in 20 min, the tuberculosis biomarker was concentrated by nearly 20-fold in simulated urine. Our method requires only 500 mW of power, and sample flow is self-driven via capillary action. As such, our technology can be readily integrated into portable, battery-powered, instrument-free diagnostic devices intended for use in low-resource settings. (Figure Presented). © 2014 American Chemical Society.


PubMed | Diagnostics For All and Tufts University
Type: Journal Article | Journal: Analytical chemistry | Year: 2016

Multiplex assays detect the presence of more than one analyte in a sample. For diagnostic applications, multiplexed tests save healthcare providers time and resources by performing many assays in parallel, minimizing the amount of sample needed and improving the quality of information acquired regarding the health status of a patient. These advantages are of particular importance for those diseases that present with general, overlapping symptoms, which makes presumptive treatments inaccurate and may put the patient at risk. For example, malaria and dengue fever are febrile illnesses transmitted through mosquito bites, and these common features make it difficult to obtain an accurate diagnosis by symptoms alone. In this manuscript, we describe the development of a multiplexed, patterned paper immunoassay for the detection of biomarkers of malaria and dengue fever: malaria HRP2, malaria pLDH, and dengue NS1 type 2. In areas coendemic for malaria and dengue fever, this assay could be used as a rapid, point-of-care diagnostic to determine the cause of a fever of unknown origin. The reagents required for each paper-based immunoassay are separated spatially within a three-dimensional device architecture, which allows the experimental conditions to be adjusted independently for each assay. We demonstrate the analytical performances of paper-based assays for each biomarker and we show that there is no significant difference in performance between the multiplexed immunoassay and those immunoassays performed in singleplex. Additionally, we spiked individual analytes into lysed human blood to demonstrate specificity in a clinically relevant sample matrix. Our results suggest multiplex paper-based devices can be an essential component of diagnostic assays used at the point-of-care.

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