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WOBURN, MA, United States

Mohamed S.,BioSense Technologies, Inc.
IET Conference Publications | Year: 2014

A point of care diagnosis system comprising of a smartphone and a method for reading the different reagent strips, that performs tests such as routine urinalysis, determining albumin to creatinine ratio and blood sugar tests based on reflectance photometry. uChek uses the camera sensor as an accurate image sensor, with the help of various image processing algorithms, to capture and perform various diagnostic tests. This system called uChek also pushes the data to a cloud database, to help monitor trends and track other useful data, making the results more accessible to labs, doctors and for demographic purposes. This system of diagnosis acts an alternative, affordable technology that not only makes the diagnosis a lot cheaper and suited to a low resource medical setup but also increases the usefulness of the data by recording seamlessly to a database and providing analysis, which helps in early detection and monitoring of treatment for various diseases.

Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 429.08K | Year: 2008

This SBIR Phase II research project develops a new rapid, nonmolecular method for quickly testing the drug susceptibility of Mycobacteria tuberculosis, the bacterium causing the epidemic disease tuberculosis (TB). Currently, all measurements for determining drug susceptibility - essential for prescribing effective treatment - rely exclusively on detecting changes in the slow growing bacterial population after exposure to drugs known to kill the bacterium. Phase I demonstrated this technology's approach to drug susceptibility testing provides commensurate information without time consuming measurements of growth. Susceptibility results were obtained in only a few hours compared to currently used methods requiring several weeks to obtain the same information. In addition, resistant strains were easily distinguished from sensitive strains inferring the ability to identify drug resistant TB infections in only a few hours time. With this information in hand quickly, physicians will be able to prescribe antimicrobial therapies with confidence because the treatments will be targeted and not empirical. The broader impacts of this research are the reduced spread of drug-resistant infections, increasing of the effective lifespan of drugs now known to cure disease, and lower healthcare costs associated with more successful patient outcomes. Rapid testing will enable better control over the spread of tuberculosis and the management of effective domestic and global policies. This will leave the United States and all other countries better prepared to mount an adequate defense in the event of an epidemic or intentional widespread exposure.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2008

DESCRIPTION (provided by applicant): Abstract The continued development of a rapid diagnostic method for testing the antibiotic susceptibility of urinary tract infections in near real-time is proposed. Currently, all methods for determining antibiotic susceptibility rely exclusively on detecting changes in the bacterial population caused by cell division after exposure to an antimicrobial compound. In our Phase I effort we demonstrated a novel phenotypic approach to antibiotic susceptibility testing that provides commensurate information without measurements of growth. Technical feasibility of this method was demonstrated by measuring the antibiotic susceptibility of both sensitive and resistant strains of Escherichia coli and Pseudomonas aer uginosa treated with antibiotics having different mechanisms of action. Susceptibility results were obtained within one hour time. In addition, resistant strains were easily distinguished from sensitive strains. Because grown cultures are no longer needed to obtain results, susceptibility results can be obtained directly from urinary specimens at the point of collection within 90 minutes total reducing the time from sample collection to availability by days enabling targeted therapy, improved patient outcom es, and the reduced spread and generation of resistant organisms. The method can be realized with a disposable device that is simple, cost effective, and ideal for mass production. The proposed Phase II effort focuses on extending our investigation to incl ude all first and second line antibiotics used to treat uropathogens and developing a prototype test instrument. Project Narrative Urinary tract infections (UTIs) are among the most common of all bacterial infections, occurring primarily in women, and accounting for as many as 8 million outpatient visits to doctors annually. Furthermore, UTIs have become the leading healthcare-associated infection among adults and children in the United States. However, the management of UTIs has become more complicated over the last decade due to increasing antimicrobial resistance to first-line antibiotics. Already, authorities advise the use of significantly more expensive fluoroquinolones as a first line treatment for uncomplicated UTIs when the prevailin g rate of antibiotic resistance in the area rises to greater than 20 percent. The same type of resistance of E. coli in other countries has reached a shocking 70 to 100 percent. Antibiotic resistance represents a problem of increasing societal importance b rought about by the overuse or inappropriate use of broad-spectrum antibiotics. The proposed rapid test is an essential tool for the responsible and prudent use of prescribed antibiotics to prevent the spread of resistant bacterial strains.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 203.22K | Year: 2016

DESCRIPTION provided by applicant Infectious disease has now entered a post antibiotic era where multi drug resistance is increasingly common There is an immediate need for new diagnostics that can determine the susceptibility of pathogenic bacteria to antibiotics rapidly and accelerate the administration of targeted therapy for optimal patient outcomes BioSense Technologies proposes the development of a new phenotypic assay for determining antibiotic minimum inhibitory concentrations MIC in minutes The technology monitors the development of antibiotic induced cellular stress as an early response for determining the effect of therapeutic agents on cellular suspensions The immediacy and ubiquity of the response enables near real time assessment of all bacterial species treated with drugs having different mechanisms of action We propose to demonstrate feasibility of the approach by measuring the early responses of isolates spanning a wide range of MIC values for six organism antibiotic combinations to construct susceptibility response profiles and corresponding database The Phase I effort will conclude with a blinded study to validate the technical approach In Phase II additional organism antibiotic combinations will be studied including all important resistance mechanisms and platform hardware will be expanded to accommodate measurement of a larger number of therapeutic agents PUBLIC HEALTH RELEVANCE The treatment of infectious diseases has now entered the post antibiotic era where drug resistant infections are commonplace as our arsenal of effective therapies dwindles There is an immediate need for new technologies to identify drug resistance as quickly as possible to administer targeted therapies Existing automated antibiotic susceptibility testing systems have assay times of hours or more depending on the organism and next day turn around times delaying the administration of targeted therapy The successful development of the proposed near real time antibiotic susceptibility technology will address this public health crisis directly as part of a new generation of clinical microbiology laboratory diagnostics The ability to pair rapid AST results with rapid ID measurements having commensurate TAT such as the recent FDA approved MALTI TOF mass spectrometry systems would enable same day results and significantly impact the administration of inappropriate therapies and overall antibiotic stewardship

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 199.69K | Year: 2011

DESCRIPTION (provided by applicant): Resistance to chemotherapeutic drugs is an ongoing problem that results in eventual treatment failures or suboptimal patient outcomes. In cancer cells treated with drugs to which they are sensitive, the stress responseis the first step in the subsequent cascade leading to cell death (apoptotic, necrotic or autophagy). The recent availability of a sensing modality for monitoring the development of stress in viable cells makes possible the utilization of stress as a diagnostic tool. BioSense Technologies proposes the development of a new diagnostic assay to determine the chemosensitivity of BCR-ABL (+) leukemia cells to therapeutic agents in real-time using unprocessed blood or bone marrow samples. Because the initiation of the stress response is immediate, drug-resistant leukemia cells can be distinguished from drug-sensitive cells in real- time avoiding any need for traditional cell culture to obtain the same information. This ability to provide the most effective therapyfor each patient will reduce treatment failures and result in overall improved patient outcomes. Importantly, because the approach monitors a property fundamental to all cells, it is directly applicable to all other cancer cells types including solid tumor cancers. Feasibility of the proposed approach will be demonstrated with established human myeloid and lymphoblastic (Ph+) cell lines both drug-sensitive and -resistant to tyrosine kinase inhibitors. A follow-on effort will focus on the development of prototype instrumentation and validate the approach through clinical testing. PUBLIC HEALTH RELEVANCE: The development of a real-time diagnostic tool for determining the sensitivity/resistance profiles of leukemia cells to therapeutic agents is a significant step towards the administration of personalized medicine and optimal patient outcomes. By addressing and overcoming a significant technical barrier (the ability to determine the effects of a therapeutic agent on a cancer cell rapidly) the proposed project enables drug-resistant cancer cells to be distinguished from drug-sensitive cells in real-time. The availability of this diagnostic tool will arm oncologists with knowledge on the most effective drugs for eliminating the cancer cells as well as monitoring the possible onset of drug resistance during the administration of treatment. These new capabilities will avoid the empirical prescription of cancer therapy and enable the start or modification of existing treatment choices as needed. While the technical approach is applicable to a spectrum of different cancer types and therapeutic agents, this project focuses on the chemosensitivity testing of leukemia cells to tyrosine kinase inhibiting agents and the identification of drug resistance as an initialdemonstration of its feasibility.

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