Irwindale, CA, United States
Irwindale, CA, United States
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Performing an electrokinetic treatment on different samples includes identifying an electrical signal that is appropriate for use in the treatment of each sample. The identification of the electrical signals results in different electrical signals being identified for different samples. The electrokinetic treatment of a sample results in that sample being exposed to the electrical signal identified for that sample. Accordingly, different samples are exposed to different electrical signals. An electrokinetic treatment employs one or more electrokinetic phenomena to cause movement of one or more agents within the sample relative to the sample. In some instances, the method also includes using each of the electrokinetically treated samples to generate an electrochemical sample and then performing an electrochemical analysis on each of the electrochemical samples.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.97M | Year: 2012

DESCRIPTION (provided by applicant): Pathogens responsible for many of the common human infectious diseases such as urinary tract infection (UTI), gastroenteritis, pneumonia, and wound infections have proven to be highly adept in acquiring mechanisms of antimicrobial resistance. Widespread injudicious practice of empiric antibiotic usage by healthcare providers and infiltration of antibiotics in the food chain have accelerated selection and dissemination of resistant pathogens. As a consequence, clinicianshave fewer treatment options, particularly in the most needy patients. An example of the problem was the rapid emergence of trimethoprim- sulfamethoxazole (SXT) resistant E. coli, which accounts for 85-90% of the UTIs in the community setting. Prior to the 1990s, beta-lactams such as ampicillin (AMP) were the standard antimicrobial regimen for acute uncomplicated UTIs, but was replaced with SXT when E. coli resistance against beta-lactams surpassed 25%. With increasing use, however, SXT resistance increased substantially and quinolones such as ciprofloxacin (CIP) became the antibiotic of choice. Not surprisingly, quinolone-resistant uropathogens are on the rise. In hospitals where MDR pathogens are of even greater problem, the quinolone-resistance rate foruropathogenic E. coli has now exceeded 50% in some settings. The goal of this Phase II NIAID Advanced Technology SBIR application is to develop and validate RAST (rapid antimicrobial susceptibility testing), an integrated diagnostic compact system to enable clinicians to direct point-of-care (POC), evidence-based selection of antibiotics for treatment of acute bacterial infections. RAST addresses the major limitations of standard phenotypic AST platforms (e.g., bioMerieux Vitek, BD Phoenix) by providing rapid (90 minutes vs. 2 days) and decentralized (POC vs. laboratory-based) testing. RAST complements our ongoing NIAID Cooperative Agreement, An Integrated Diagnostic Biochip for Point of Care Pathogen Identification (U01 AI082457), for rapid molecular diagnosis urinary tract infections (UTI) using electrochemical biosensors integrated with microfluidics. Since Phase I, we have accomplished several critical milestones: (1) development and clinical validation of a 3.5 hour bench-top RAST protocol showing 94% accuracy; (2) compatibility of RAST with clinical urine samples without need for initial bacterial isolation; (3) feasibility of on-chip electrokinetic bacterial concentration and assay enhancement; (4) on-chip bacterial culture using microchannels; (5) integrated microfluidic cartridge for pathogen identification; and (6) preliminary feasibility of cartridge-based RAST. In the current Phase II project, we propose three Specific Aims: Specific Aim 1. Optimization and validation of electrokinetic (EK) processing modules for volume reduction and in situ assay enhancement. The goal of Aim 1 is to develop an EK volume reduction module for enriching the sample 100-fold within 10 min and to develop an in situ EK enhancement technique for improving the detection sensitivity of the electrochemical assay by 10-fold. Specific Aim 2. Development of the RAST cartridge for rapid phenotypic antimicrobial susceptibility testing. The goal of Aim 2 is to develop the process flow and fabrication process for the RAST cartridge and reader/manifold system, including sample loading, EK volume reduction, on-chip sample culturing in selective media containing different antibiotics of interest, and phenotypic AST by quantitative measurement of bacterial 16S rRNA. Specific Aim 3. Clinical translation of RAST cartridge in urine. The goal of Aim 3 is to perform analytical validation of RAST cartridge and reader/manifold system and a clinical feasibility study using 30 unknown clinical samples from patients suspected to have UTI. The development and validation of RAST will adhere to the recommended standards of Quality Management Standard for Medical Devices (ISO 13485) and federal regulations for fully automated short-term incubation cycle antimicrobial susceptibility system (21 CFR 866.1645)(see Commercialization Plan D.1.3). Successful accomplishment of our milestones in this Phase II application will be followed by FDA 510(k) submission to demonstrate the system is substantially equivalent to a predicate device. A separate Milestones andTimeline section is included at the end of the Research Strategy. PUBLIC HEALTH RELEVANCE: Development of a compact platform capable of rapid pathogen ID and AST directly from patient's samples can provide clinicians at the point of care (e.g., outpatient office, emergency department) with evidenced-based information to start patient-specific antimicrobial treatment only when necessary. Rapid susceptibility test results and alterations in the use of antibiotics, even short-term, have been found tofavorably impact patient care and the antibiotic resistance profiles.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 747.72K | Year: 2016

DESCRIPTION provided by applicant The key objective of this proposed product development effort is to optimize the treatment of infections and reduce adverse events associated with inappropriate antibiotic use according to each NICUandapos s locally established antibiogram with a fully automated evidence based rapid PID AST system The ultimate goal of the proposed neonatal sepsis CentriCapillary system after successful completion of this SBIR fast track is to initially address analysis needs in NICU settings then in the entire blood culture market currently estimated to total more than $ billion in the United States alone Neonates are not small adults It is not practical to design a diagnostics system using mL blood culture bottles for adults and only load mL of blood sample for neonates Undoubtedly there is a risk of missing the target pathogen for extremely low level bacteremia e g below CFU mL using small blood sample volume but it is not practical or even possible to obtain more than mL of blood routinely from neonates in the NICU for PID and AST lab tests Currently there is no commercial system or product development effort from major diagnostics companies to address neonatal sepsis screening specifically using smaller blood volume We developed demonstrated and published an innovative molecular based genotypic phenotypic hybrid approach for multiplexed bacterial PID and AST profiling with clinical sensitivity clinical specificity minimum inhibitory concentration MIC and categorical agreement in our most recent ongoing clinical feasibility study on raw clinical urine samples In this fas track SBIR project we will leverage our expertise in microfluidics electrochemical biosensors and clinical microbiology to develop an integrated CentriCapillary system While our molecular analysis technology has been validated with multidrugresistant pathogens MDR that cause UTI which is the most common bacterial infection it is anticipated that the incorporation of the lysis centrifugation and dynamic hybridization will have applicability for rapid neonatal sepsis PID AST and other emerging infectious diseases PHASE I STUDY YEAR Specific Aim Transition the current PID AST platform technology from urinary tract infection UTI to neonatal sepsis Hypothesis Lysis centrifugation can address the change of matrix effect from raw urine to whole blood samples and the issue of low abundant pathogen for neonatal sepsis by using a CentriCapillary cartridge for blood pelleting assisted rapid blood culture on various low blood volumes from neonates L mL Specific Aim Demonstrate the feasibility of the electrochemical based molecular analysis CentriCapillary cartridge Hypothesis Microfluidic cartridge based blood pelleting can capture and recover all common pathogens on the YNHH NICUandapos s antibiogram for rapid neonatal sepsis PID and AST PHASE II STUDY YEARS AND Specific Aim Develop a dual mode electrochemical based dynamic hybridization analysis algorithm to expand the PID AST panel Hypothesis Dynamic hybridization analysis can be utilized to expand the species specific identification of common and emerging pathogens for neonatal sepsis Specific Aim Prototype validate and manufacture the CentriCapillary cartridge COGSandlt $ and system COGSandlt $ k Hypothesis Ultracentrifugation up to g gravitational force can be incorporated into a multiplexed fluidic cartridge for a fully automated neonatal sepsis PID AST from whole blood samples in hours Specific Aim Clinically validate the rapid neonatal PID AST CentriCapillary system according to CLSI guidelines Hypothesis Blood samples spiked with ATCC strain bacteria used in the analytical validation studies represent critical matrix characteristics of fresh whole blood samples from neonates The development and validation of neonatal sepsis will adhere to the ISO standards FDA CDC CLSI guidelines on AST and federal regulation CFR The ultimate goal of this study is to reduce adverse events associated with inappropriate antibiotic use in the NICU settings PUBLIC HEALTH RELEVANCE There are M births annually in the United States with in births classified as premature Premature infants are at greater risk of major medical issues and the financial impact is $ B annually or $ K per infant There are more than NICU beds in the United States but there are no technologies or products available specifically to address the low blood volume drawn from neonates The ultimate goal of the proposed rapid neonatal sepsis screening system after successful completion of this clinical feasibility study is to initially address analysis needs in NICU settings then in the entire blood culture market currently estimated to total more than $ billion in the United States alone with GeneFluidicsandapos current molecular analysis pathogen identification PID and antimicrobial susceptibility testing AST platform


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.47K | Year: 2015

DESCRIPTION provided by applicant The key objective of this proposed product development effort is to optimize the treatment of infections and reduce adverse events associated with inappropriate antibiotic use according to each NICUandapos s locally established antibiogram with a fully automated evidence based rapid PID AST system The ultimate goal of the proposed neonatal sepsis CentriCapillary system after successful completion of this SBIR fast track is to initially address analysis needs in NICU settings then in the entire blood culture market currently estimated to total more than $ billion in the United States alone Neonates are not small adults It is not practical to design a diagnostics system using mL blood culture bottles for adults and only load mL of blood sample for neonates Undoubtedly there is a risk of missing the target pathogen for extremely low level bacteremia e g below CFU mL using small blood sample volume but it is not practical or even possible to obtain more than mL of blood routinely from neonates in the NICU for PID and AST lab tests Currently there is no commercial system or product development effort from major diagnostics companies to address neonatal sepsis screening specifically using smaller blood volume We developed demonstrated and published an innovative molecular based genotypic phenotypic hybrid approach for multiplexed bacterial PID and AST profiling with clinical sensitivity clinical specificity minimum inhibitory concentration MIC and categorical agreement in our most recent ongoing clinical feasibility study on raw clinical urine samples In this fas track SBIR project we will leverage our expertise in microfluidics electrochemical biosensors and clinical microbiology to develop an integrated CentriCapillary system While our molecular analysis technology has been validated with multidrugresistant pathogens MDR that cause UTI which is the most common bacterial infection it is anticipated that the incorporation of the lysis centrifugation and dynamic hybridization will have applicability for rapid neonatal sepsis PID AST and other emerging infectious diseases PHASE I STUDY YEAR Specific Aim Transition the current PID AST platform technology from urinary tract infection UTI to neonatal sepsis Hypothesis Lysis centrifugation can address the change of matrix effect from raw urine to whole blood samples and the issue of low abundant pathogen for neonatal sepsis by using a CentriCapillary cartridge for blood pelleting assisted rapid blood culture on various low blood volumes from neonates L mL Specific Aim Demonstrate the feasibility of the electrochemical based molecular analysis CentriCapillary cartridge Hypothesis Microfluidic cartridge based blood pelleting can capture and recover all common pathogens on the YNHH NICUandapos s antibiogram for rapid neonatal sepsis PID and AST PHASE II STUDY YEARS AND Specific Aim Develop a dual mode electrochemical based dynamic hybridization analysis algorithm to expand the PID AST panel Hypothesis Dynamic hybridization analysis can be utilized to expand the species specific identification of common and emerging pathogens for neonatal sepsis Specific Aim Prototype validate and manufacture the CentriCapillary cartridge COGSandlt $ and system COGSandlt $ k Hypothesis Ultracentrifugation up to g gravitational force can be incorporated into a multiplexed fluidic cartridge for a fully automated neonatal sepsis PID AST from whole blood samples in hours Specific Aim Clinically validate the rapid neonatal PID AST CentriCapillary system according to CLSI guidelines Hypothesis Blood samples spiked with ATCC strain bacteria used in the analytical validation studies represent critical matrix characteristics of fresh whole blood samples from neonates The development and validation of neonatal sepsis will adhere to the ISO standards FDA CDC CLSI guidelines on AST and federal regulation CFR The ultimate goal of this study is to reduce adverse events associated with inappropriate antibiotic use in the NICU settings PUBLIC HEALTH RELEVANCE There are M births annually in the United States with in births classified as premature Premature infants are at greater risk of major medical issues and the financial impact is $ B annually or $ K per infant There are more than NICU beds in the United States but there are no technologies or products available specifically to address the low blood volume drawn from neonates The ultimate goal of the proposed rapid neonatal sepsis screening system after successful completion of this clinical feasibility study is to initially address analysis needs in NICU settings then in the entire blood culture market currently estimated to total more than $ billion in the United States alone with GeneFluidicsandapos current molecular analysis pathogen identification PID and antimicrobial susceptibility testing AST platform


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 223.63K | Year: 2015

DESCRIPTION provided by applicant Persistent infection by HPV causes cancers and can be prevented About million American women are infected with HPV with about million becoming newly infected each year In there were American women diagnosed with cervical cancer and cervical cancer deaths Persistent infection by HPV is a necessary factor in the pathologic process which may lead to cervical cancer development Cervical cancer is a major fatal malignancy among women causing about deaths annually worldwide mostly in developing countries Cervical cancer is also a highly preventable disease if detected at its precancerous stages and treated by ablative procedures The current HPV tests do not screen for persistent HPV infection HPV testing has a clinical role in identifying individuals with an increased risk of an HPV associated cervical precancer or cancer Four tests are currently approved by the Food and Drug Administration FDA for detecting clinically significant levels of any of high risk HPV types the Qiagen Digene Hybrid capture r HC Qiagen Gaithersburg MD the Hologic Genprobe Cervista r HPV Hologics Bedford MA the Hologic Genprobe APTIMA r HPV Hologics Bedford MA and the Roche cobas r HPV test Roche Molecular Systems Pleasanton CA But the FDA approved indication of these tests is high risk HPV infection not persistent high risk HPV infection Studies have shown that more than of new HPV infections including those with high risk types clear or become undetectable within two years and clearance usually occurs in the first months after infection One of the key features of cervical cancer is its slow progression from normal cervical tissue to precancerous or dysplastic changes in the tissue to invasive cancer The average time for progression of cervical intraepithelial neoplasia CIN to invasive cancer has been estimated to be to years and there is a small subset of rapidly progressive cervical cancers which are diagnosed within years of a confirmed negative Pap test Hence most high risk HPV infections will be cleared by bodyandapos s immune system in months and only a smaller percentage of high risk HPV infections become persistent and develop into invasive cervical cancer after to years A positive hrHPV result from the current FDA approved Rocheandapos s cobas HPV DNA test immediately calls for a colposcopy while most hrHPV infections will not become persistent However it is difficult to conduct a follow up test months after the first positive hrHPV infection because the current HPV tests are not easily accessible unfriendly and invasive Persistent infection with high risk HPV is the most important risk factor for cervical cancer precursors and invasive cervical cancer Cervical cancer is primarily a disease among unscreened or rarely screened women Only less than of HPV infection will lead to invasive cervical cancer therefore a more clinically relevant screening test would detect persistent high risk HPV infection not just high risk HPV infection Discomfort and inconvenience are two major barriers of the follow up test to confirm persistent infection Therefore a self administered HPV POC test on non invasive samples such as urine and saliva along with education can significantly improve the HPV screening rate and one HPV test in a womanandapos s lifetime can decrease cancer mortality by as compared to standard of care The ultimate goal of this SBIR effort is to increase the HPV screening rate by demonstrating a non invasive POC HPV test enabled by a smartphone mounted with a PocketLab In the following Phase II study the HPV test panel will be expanded to HPV DNA a pool of other hrHPV DNA E E oncoproteins and the system control and reagent delivery will be replaced by a palm sized PocketLab This proposed SBIR Phase I study will demonstrate a smartphone based HPV screening device to detect hrHPV DNA and oncoproteins E E from non invasive specimens such as urine saliva and swabs All four FDA approved HPV DNA tests are intended for use by trained laboratory personnel who are proficient in performing real time PCR assays in a well equipped clinical diagnostics laboratory These tests require access to sophisticated and expensive lab equipment which is not widely available in developing countries and several manual processing steps which increase the chances for contaminations The proposed HPV PocketLab cartridge integrates the sample processing target amplification and detection steps of the HPV amplification assay and immunoassay into a single inexpensive disposable cartridge that contains all necessary lyophilized reagents and requires no manual steps other than sample loading PUBLIC HEALTH RELEVANCE The most effective way to save lives is to help women get screened with non invasive tests A self administered HPV POC test on non invasive samples such as urine and saliva along with education can significantly improve the HPV screening rate and one HPV test in a womanandapos s lifetime can decrease cancer mortality by as compared to standard of care


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 434.33K | Year: 2010

DESCRIPTION (provided by applicant): Standard culture-based diagnosis of bacteremia, including pathogen identification (ID) and antimicrobial susceptibility testing (AST), requires 2-3 days for clinical sample acquisition to result reporting. The absence of definitive microbiological diagnosis at the point of care has largely driven the over- and misuse of antibiotics in the neonatal intensive care unit (NICU), resulting in an increase in proportion and prevalence of antibiotic-resistance organisms. While microbiological diagnosis has improved with the availability of high throughput, automated instruments in the larger clinical microbiology laboratories, the process remains time-consuming and requires significant technical expertise. Standard automation instruments are bulky and typically require a priori isolation of the pathogens from the body fluid samples prior to AST. The significant work burden of a modern clinical microbiology laboratory has led to an increase in outsourcing practice of clinical laboratory tests. Development of a point-of-care (POC) platform capable of rapid pathogen identification and AST can provide clinicians with evidence-based information to start patient-specific antimicrobial treatment only when necessary. Even short-term alterations in the use of antibiotics have been found to favorably impact the antibiotic resistance profiles. Furthermore, such platform could potentially expedite the screening of novel class of antibiotics. In this proposal, we will leverage our ongoing development on the point-of-care diagnostic platform for urine and saliva testing (U01 AI082457 and U01 DE017790) to create an integrated diagnostic cartridge specifically for rapid blood testing by incorporating a complementary rapid blood cell removal cross-flow filter and an electrokinetic (EK) concentrator. The proposed study will utilize cross-flow filtration to replace centrifugation, employ high aspect-ratio gas-permeable microchannels to obtain optimal conditions for rapid phenotypic assessment of bacterial growth, exploit EK sample preparation techniques for on-chip matrix management, and develop an electrochemical-based fluidic cartridge to obtain pathogen identification and antimicrobial susceptibility assessment from infected blood samples in 90 minutes. The ultimate goal of this project is to leverage the advancement of the established microfluidic cartridge technology and the phenotypic assay to develop a POC platform for diagnosing bacteremia in the NICU. While the goal for Phase 1 is to develop a microfluidic cartridge for diagnosing E. coli infection, this platform will be extended to diagnose infections caused by other prevalent pathogens found in the NICU in Phase 2 upon completion of Phase 1. Specific Aims 1 and 2 of this project is to investigate and develop cross-flow filtration and EK manipulation for matrix management, and rapid antibiotic susceptibility testing in fluidic channels. The outcome of the proposed Aim 1 will remove 95% of blood cells with a PDMS-based cross-flow filter with a two-tier micro-channel design. The focus of Specific Aim 2 is to measure the impedance of the cross-flow filtered blood and apply the optimal EK manipulation conditions to each blood specimen based on the impedance analysis. The flow channel geometry, materials and fabrication details will be comparable with the fluidic cartridge to be built in Specific Aim 3. The design inputs from the Specific Aim 1 and 2 will be incorporated into the antibiotic susceptibility testing (RAST) cartridge. The goal of Specific Aim 3 is to develop and validate the RAST fluidic cartridge with standard and fresh blood samples spiked with known E. coli concentrations. The passing criteria of Specific Aim 3 is to achieve 100% agreement when comparing blood culture results with results acquired by the microfluidic cartridge and associated control system in 90 minutes under optimal RAST assay conditions obtained in Specific Aim 1 and 2. We will validate the RAST cartridge with 10 spiked whole blood samples to demonstrate the ability to obtain antibiotic susceptibility in 90 minutes with known antibiotic-resistant E. coli provided by Childrens Hospital Los Angeles in Phase I study. In Phase II, we plan to incorporate the pathogen identification and RAST into an integrated fluidic cartridge for a multi-center validation study with an expanded panel of other common pathogens. The clinical study in Phase II will be led by Dr. Grace Aldrovani at Childrens Hospitals Los Angeles. The sample size and enrollment plan will be finalized toward the end of the Phase I study. PUBLIC HEALTH RELEVANCE: Standard culture-based diagnosis of bacterial infections, including pathogen identification and antimicrobial susceptibility testing require 2-3 days for clinical sample acquisition to result reporting. The absence of definitive microbiological diagnosis at the point of care has led to over- and misuse of antibiotics in neonatal intensive care units. We proposed to develop an integrated diagnostic cartridge specifically for rapid bacteremia diagnosis by utilizing high aspect-ratio gas-permeable microchannels to obtain optimal conditions for rapid phenotypic assessment of bacterial growth, employing cross-flow filtration and electrokinetic manipulation techniques for on-chip matrix management, and developing an electrochemical- based fluidic cartridge to achieve pathogen identification and obtain antimicrobial susceptibility assessment from infected blood samples in 90 minutes.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 700.47K | Year: 2010

DESCRIPTION (provided by applicant): Program Director/Principal Investigator (Last, First, Middle): Gau, Vincent Project summary and abstract Standard culture-based diagnosis of bacterial infections, including pathogen identification (ID) and antimicrobial susceptibility testing (AST), require 2-3 days for clinical sample acquisition to result reporting. The absence of definitive microbiological diagnosis at the point of care has largely driven the over- and misuse of antibiotics. While microbiological diagnosis has improved with the availability of high throughput, automated instruments in the larger clinical microbiology laboratories, the process remains time-consuming and requires significant technical expertise. Standard automation instruments are bulky and typically require a priori isolation of the pathogens from the body fluid samples prior to AST . The significant work burden of a modern clinical microbiology laboratory has led increasingly to the practice of outsourcing of clinical laboratory tests. Development of a point-of-care platform capable of rapid pathogen ID and AST can provide clinicians with evidenced-based information to start patient-specific antimicrobial treatment only when necessary. Even short- term alterations in the use of antibiotics have been found to favorably impact the antibiotic resistance profiles. Furthermore, such platform may be useful to expedite screening of novel class of antibiotics. In this proposal, we will leverage our ongoing efforts to develop an integrated diagnostic biochip for rapid pathogen identification (U01 AI082457) by developing a complementary rapid antimicrobial susceptibility testing (RAST) biochip. This proposed study will utilize high aspect ratio, gas permeable microchannels to obtain optimal conditions for rapid phenotypic assessment of bacterial growth and electrokinetic (EK) sample preparation techniques for on chip matrix management, and develop an electrochemical-based RAST fluidic cartridge to obtain antimicrobial susceptibility assessment from confirmed positive patient populations in 90 minutes. The ultimate goal of the AST development is to leverage the advancement of the established microfluidic cartridge technology and the phenotypic assays developed among all key personnel in the assembled team to establish a comprehensive understanding of not only just the urine specimen but also other body fluids. The overall focus of Aim 1 is to characterize the physical properties of the specimen matrix with various impedance analyses and provide a controllable approach to minimize the matrix effect with electrokinetic trapping. By assessing the impedance mapping of each specimen to be tested, a customized electrokinetic sample preparation will be applied to obtain the maximum extraction efficiency instead of using a universal condition for a wide range of specimen conditions. The outcome of the proposed Aim 1 will provide comprehensive impedance mapping of 98% of urine specimens with impedance analysis and this information will be linked to the optimal EK manipulation conditions to be developed in Aim 1. The passing criteria of Specific Aim 2 is to achieve 100% agreement comparing to urine culture with the microfluidic cartridge and associated control system in 90 minutes compared to urine culture. PHS 398/2590 (Rev. 11/07) Page 1 Continuation Format Page PUBLIC HEALTH RELEVANCE: The absence of definitive microbiological diagnosis at the point of care has led to over- and misuse of antibiotics. We propose to develop a biochip-based rapid AST by utilizing high aspect ratio, gas permeable microchannels for rapid phenotypic assessment of bacterial growth, electrokinetic (EK) sample preparation techniques for on chip matrix management, and develop an electrochemical-based RAST fluidic cartridge to obtain antimicrobial susceptibility assessment from infected urine samples in 90 minutes. PHS 398/2590 (Rev. 11/07) Page 1 Continuation Format Page


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 989.57K | Year: 2016

ABSTRACT Currently there are no FDA cleared molecular based tests for urinary tract infection UTI pathogen identification and antimicrobial susceptibility testing to replace the andapos gold standardandapos of dipstick urinalysis and urine culturing All pathogen identification tests still rely on clinical isolates from urine cultures largely unchanged from Kochandapos s postulates developed in the th century as general guidelines to identify pathogens What has changed over time however is the dramatic and progressive emergence of antibiotic resistance among these pathogens Data from the Centers for Disease Control and Prevention CDC National Healthcare Safety Network NHSN indicate that of the pathogens isolated from hospital acquired infections HAIs now are resistant to at least major classes of antibiotics Recent developments in molecular diagnostic testing for multidrug resistant MDR pathogens can provide a sensitive specific and real time solution to support active surveillance driven infection control interventions but these PCR based tests can only be performed on simple specimen matrices such as swabs or positive blood culture media blood to broth ratio No molecular based method is cleared by the FDA to test directly on urine or whole blood samples The goal of this Commercialization Readiness Pilot CRP Grant is to accelerate the commercialization effort of the program outcome from our NIAID SBIR R AI project titled An Integrated Diagnostic System for Rapid Antimicrobial Susceptibility Testing AST We propose technical assistance on regulatory strategy development and cost effective manufacturing as well as later stage research and development activities on independent replication of key studies in compliance with FDA requirements and ISO standards The goal of our NIAID Advanced Technology SBIR project is to develop and validate RAST rapid antimicrobial susceptibility testing an integrated and compact diagnostic system that enables clinicians direct point of care POC with an evidence based selection of antibiotics for treatment of acute bacterial infections Our first compact automated system is capable of rapid pathogen identification ID and AST directly from patientandapos s samples with evidenced based information to start patient specific antimicrobial treatment It is expected to obtain a CE Mark after the coming ISO surveillance certification audit in February However the FDA clearance is hindered by no molecular based predicate test cleared by the FDA for urinary tract infections UTI the low cost of conventional dipstick urinalysis tests and the lack of fresh urine specimens through a multi site clinical feasibility study We will overcome these hurdles through the following aims TECHNICAL ASSISTANCE Aim Obtain a risk based classification of the Class II device through a de novo request with external regulatory assistance from NSF International an international certification organization in months Aim Reduce the cost of goods sold of andlt $ for cartridge and andlt $ k for system with external manufacturing development assistance LATE STAGE RESEARCH AND DEVELOPMENT ACTIVITIES Aim Conduct a multi center clinical performance study and demonstrate andgt clinical sensitivity specificity and andgt susceptibility categorical agreement In this study we focus on validating the rapid UTI diagnostic device according to federal regulations CFR microorganism differentiation and identification device CFR antimicrobial susceptibility test powder and CFR fully automated short term incubation cycle antimicrobial susceptibility testing system The FDA product codes for such systems are JSS and LON The regulatory strategy will be finalized in Aim Regulatory for preparation of the clinical protocol and multicenter clinical performance study in Aim Clinical study that will utilize the cost effective system and consumables optimized in Aim Manufacturing Narrative The main goal of this CRP research project is to accelerate the commercialize of the SBIR program outcome that integrates lab automation rapid molecular analysis genotypic pathogen quantification and phenotypic antibiotic conditions to dramatically improve the sensitivity and specificity of rapid evidence based pathogen identification ID and antimicrobial susceptibility testing AST directly from patient fresh urine samples


Patent
Genefluidics, Inc. | Date: 2013-06-07

The cartridge includes a sensor structure that has multiple sensors positioned on a substrate. The cartridge also includes a common channel defined in the substrate such that a fluid flowing in the common channel contacts each of the sensors as a result of the fluid flowing from an inlet of the common channel to an outlet of the common channel.


Patent
University of Arizona and Genefluidics, Inc. | Date: 2013-06-25

Described herein are microfluidic diagnostic methods and devices using electrokinetic modules for the isolation of targets (e.g., cells, bacteria, biomolecules) from biological samples, PCR amplification of DNA isolated from the targets, and real-time quantification of the amplified DNA using impedance sensing. Sample preparation, PCR amplification, and impedance sensing are thus performed using a single integrated platform.

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