Top 5 Step Two Finalists

Affinity Biosensors
Ultra-Rapid Infection Confirmation and Phenotypical AST by Microbe Mass Measurement
Ken Babcock

The spread of antimicrobial resistance can be slowed by reducing the time needed to administer an effective, targeted antibiotic to infected patients. Our response to the AMR Challenge is a test that detects the presence of highly resistant strains of bacteria and also identifies the best targeted therapies in just a couple of hours, radically faster than the current standard of 2-3 days.  The test employs a novel microfluidic sensor that weighs individual microbes at high throughput.  Its rich data set rapidly detects bacterial growth and response to a panel of the most advanced antibiotics, and in key cases can do so even faster than the microbes themselves can multiply.  The test targets blood stream infection and sepsis, acute urinary tract infection, and bacterial meningitis, maladies for which positive patient outcomes rely on rapid diagnostics.  Notably, the test has been shown to successfully diagnose the most pernicious “superbugs,” i.e., those that are resistant to multiple advanced antibiotics and which are notoriously difficult to diagnose in rapid timeframes.  Because it assesses growth phenotypically, the test will not be defeated as microbes evolve new resistance mechanisms, and it can be easily extended to additional sources of infection and to new antibiotics as they are developed.  To ensure that the test will be readily adopted in the today’s clinical environment it has been automated, accommodates many samples, is easy to use, and is cost-effective.

 

Click Diagnostics, Inc.
Patient-side, Disposable, Molecular PCR Diagnostic Device for Neisseria Gonorrhea and Drug Resistance Markers
Gary Schoolnik

Click Diagnostics was founded with the mission to dramatically improve health outcomes by providing physicians with “patient-side” test results enabling immediate and accurate treatment. Through dramatic miniaturization, optimization, and cost reduction of laboratory polymerase chain reaction (PCR) technology, Click has created a fast, inexpensive, single-use (disposable) molecular diagnostic device. This device integrates and automates sample processing, PCR amplification, and amplicon detection into a simple, easy-to-use test. As the device does not require a separate instrument, it enables moving molecular testing from laboratories and large healthcare facilities to point-of-care locations, such as clinics, retail pharmacies, and eventually the home. Click’s first product for detecting the sexually transmitted infections N. gonorrhoeae, C. trachomatis and T. vaginalis is currently in a combined 510(k)/CLIA-waiver clinical study. In this project, Click is adding a Neisseria gonorrhoeae ciprofloxacin drug-susceptibility indication to this Sexual Health test. The CDC has classified Neisseria gonorrhoeae as an urgent threat since it is rapidly becoming resistant to antimicrobials. A point-of-care test, such as proposed here, integrating drug-susceptibility information with diagnostic testing will guide treatment decisions, improving patient outcomes through personalized treatment, extending the life of older antibiotics, and reducing the prescription of ineffective antibiotics.

 

GeneFluidics
Fully Automated Pathogen ID and AST Directly from Blood and Urine
Vincent Gau

The emergence and rapid spread of resistant bacteria has become a serious public health concern worldwide. Delayed antimicrobial therapy significantly increases mortality in high-risk infections with a particularly strong association with septic shock. Therefore, antimicrobial agents are often injudiciously used without any evidence-based microbiological confirmation. Antibiotic consumption is strongly linked to the emergence and dissemination of antibiotic-resistant bacteria strains in several epidemiological studies. According to CDC’s recent publication, an estimated 30% of outpatient oral antibiotic prescriptions may have been inappropriate, and up to 70% of the “appropriate” prescriptions still require improvements in selection, dosage and duration to delay the development of antibiotic-resistant bacteria. The vast majority of antibiotic prescriptions are made by physicians outside the hospital setting without the use of a sophisticated diagnostic device. A compact and rapid pathogen identification (ID) and antimicrobial susceptibility testing (AST) can address both the unnecessary use and overuse of antibiotics, and therefore effectively reduce antibiotic microbial resistance. Our overall goal is to deliver a molecular diagnostic platform that is capable of rapid diagnosis of common bacterial infections in as short as 30 minutes and profiling their antibiotic resistance in as short as 90 minutes. Our product will lead to more rational use of antibiotics and will reduce the development and spread of multidrug-resistant pathogens. Our goal is to obtain the first FDA clearance of UtiMax, a rapid urinary tract infection ID/AST test currently in the pilot production stage, through a FDA de novo submission. A follow-up product line, BsiMax (with additional feature of lysis centrifugation), can process whole blood samples for bloodstream infections with a limit of detection (LOD) < 4 CFU/mL. Both UtiMax and BsiMax can be performed by our robotic liquid handling systems, with associated reagent kits and sensor chips. INTENDED USE – BsiMax (UtiMax) is a rapid diagnostics test to identify blood borne pathogens (uropathogens) directly from patients’ whole blood (fresh urine) samples. The BsiMax (UtiMax) ID/AST test can quantify the unique species-specific nucleic acid sequence associated with each target pathogen without using PCR and conduct antimicrobial susceptibility testing (AST) without a need of obtaining a clinical isolate or positive blood (urine) culture sample.

 

Klaris Diagnostics
Single Cell Biometric Analysis for Rapid ID/AST
Kyle Fieleke

Klaris is developing a single cell analysis platform that enables fast, targeted antibiotic treatment by delivering rapid pathogen identification (ID) and phenotypic antimicrobial susceptibility test (AST) results.  We accomplish ID and AST using a new method that reduces system complexity, enables cost-effective testing, and permits testing directly from challenging non-sterile specimens.  The Klaris platform utilizes phenotypic susceptibility testing methods, ensuring the clinical validity of current gold standard AST methods is maintained for rapid testing.

Conventional antibiotic susceptibility testing requires laboratory processing time that often exceeds 48 hours.  As a result, clinicians must treat empirically, often utilizing broad spectrum antibiotics while they await culture results.  This approach has triggered a cycle wherein empiric therapy regimens must periodically escalate to next-line antibiotics to account for increasing prevalence of resistance.  Rapid ID/AST tests can help thwart this cycle by dramatically shortening the empiric treatment time window.  Earlier therapeutic optimization will maintain patient outcomes while also helping to preserve a precious and limited public resource: the efficacy of our most potent antibiotics.

 

Predigen, Inc.
Host Gene Expression to Classify Viral and Bacterial Infection Using Rapid Multiplex PCR
Ephraim Tsalik

Inappropriately prescribed antibacterials for viral respiratory illness contribute to increased healthcare costs, unnecessary drug-related adverse effects, and drive antimicrobial resistance. The inability to rapidly and reliably distinguish bacterial from viral or non-infectious etiologies is a major impediment to appropriate antibiotic use. Currently available diagnostic strategies focus largely on pathogen detection although they are limited by poor sensitivity, long time-to-result, inability to distinguish infection from colonization, or restricted number of target pathogens. An alternative diagnostic strategy is to focus on the host’s response. The host (patient) responds to bacterial and viral causes of acute respiratory illness (ARI) in distinct and stereotypic ways. Based on that principle, we offer an innovative solution focusing on the patient’s response to infection. By combining machine learning analyses with system-wide gene expression measurements, we at Duke University and a recently formed spinout, Predigen Inc., have identified host response patterns that distinguish bacterial, viral, and non-infectious etiologies. Supported by the NIH-sponsored Antibacterial Resistance Leadership Group (ARLG), we embarked on a diagnostic development pathway called RADICAL (Rapid Diagnostics in Categorizing Acute Lung Infection), which has validated these host response signatures and supported a collaboration with BioFire Diagnostics. As a result, we have developed a 45-minute, sample-to-answer test that uses host gene expression to distinguish bacterial from viral infection.

 

Other Step Two Entries

Brigham and Women’s Hospital, Harvard Medical School
Breath Volatile Metabolites for the Rapid Identification of Pneumonia Etiology
Sophia Koo

Community acquired pneumonia (CAP) is the fourth leading cause of death worldwide, with 430-450 million cases and 3-4 million deaths per year. In the United States alone, there are 4-5 million CAP cases, 1.1 million hospitalizations, and over 52,000 deaths annually, accounting for over $34 billion in direct health expenditures. Despite the high incidence of CAP, existing diagnostic tests for CAP are inadequate, identifying an underlying microbial pathogen in only 20-38% of cases. Even when a specific causal pathogen is identified, results often return long after it is necessary to make a clinical treatment decision. Because of the difficulty of identifying the microbial cause of pneumonia and the potentially severe consequences of not treating bacterial pneumonia promptly, clinicians often treat CAP empirically with antibiotics, even though the majority of these cases are ultimately viral in etiology. Unnecessary broad-spectrum antibiotic prescriptions per year, in turn, fuel the emergence and spread of resistant bacteria, including most of the urgent and serious threat level pathogens on the Center for Disease Control and Prevention’s list of urgent and antibioticresistant threats, on a population level. We propose a novel approach to CAP diagnosis based on distinct differences in the breath volatile metabolite profiles of patients with bacterial vs. viral pneumonia, using a novel rapid, portable gas chromatography-differential mobility spectrometry (GC-DMS) Microanalyzer device at the point of care to detect specific volatile metabolite signatures that differentiate bacterial vs. viral CAP. This rapid breath test for CAP would guide antimicrobial treatment decisions at the point of care, sharply reducing antibiotic prescribing in patients who do not have bacterial pneumonia and slowing emergence of antimicrobial resistance on a population level.

 

First Light Biosciences, Inc.
Platform for Detecting Infections and Determining Appropriate Therapy Rapidly, Accurately, and Cost-Effectively
Don Straus

First Light Biosciences is addressing two critical issues in healthcare: the rise in superbugs that are resistant to most antibiotics and the epidemic of hospital acquired infections. Today, a large fraction of life threatening infections seen in hospitals are caused by pathogens that are resistant to multiple antibiotics. Effective treatment and cure requires rapid diagnostics to detect infections and select appropriate antibiotics for treatment. Today’s tests require days to determine the therapy that best targets a patient’s infection. We propose to develop tests based on First Light’s MultiPath technology that can rapidly and affordably detect a broad range of infections, accurately identify the infectious agents, and determine the appropriate antibiotic for treatment. In only 30 min it detects infections and identifies pathogens including bacteria, fungi, viruses, toxins, human cells, and biomarkers. The technology can determine the appropriate antibiotic therapy in just 4 hours in contrast to the several days required by current methods. A unique advantage of the technology is its ability to deliver rapid and accurate antimicrobial susceptibly test (AST) results directly from any sample type including non-sterile samples and samples with polymicrobial infections. The MultiPath platform consists of an automated benchtop analyzer that accommodates a broad menu of application-specific consumable cartridges. While as sensitive as high performance central laboratory tests, the MultiPath tests are as rapid and as easy-to-use as point-of-care tests and require no sample preparation even for the most complex matrices. The proprietary MultiPath technology achieves high sensitivity and quantification by using digital non-magnified imaging to count fluorescently labeled cellular and molecular targets. The MultiPath Platform eliminates labile enzymatic reagents, biochemical purification, and liquid handling (including wash steps), reducing complexity and cost while increasing throughput. We are developing an automated benchtop MultiPath Analyzer that will accommodate a broad menu of application-specific consumable cartridges that will address important unmet needs in clinical microbiology diagnostics. Although focused initially on the hospital infection diagnostics market, the products we are developing will also have commercial and medical advantages at the point-of-need in outpatient settings. In this Step 2 application we describe the work that we have carried out since our Step 1 submission on the development of the MultiPath Analyzer, MultiPath Cartridge, MultiPath CDI Test for Clostridium difficile infection diagnosis, and MultiPath UTI ID/AST which detects urinary tract infections, identifies the pathogen, and determines antibiotic susceptibility.

 

GeneCapture
GeneCapture POC Rapid, Affordable Pathogen IVD and Phenotypic AMR Determination
Paula Koelle

GeneCapture, Inc. has developed a robust, enzyme-free assay for direct identification of bacterial, viral and fungal pathogenic RNA in 45 minutes.  A follow-on phenotypic bacterial AMR test from the same patient sample yields results in as little as 5-45 minutes. GeneCapture is developing a broad screen, sample-in/answer-out, affordable, point of care (POC) diagnostic for physician offices, emergency rooms, urgent care centers and disaster sites.   Facilitating effective treatment decisions in an hour will greatly improve patient outcomes and provide important information specific to antibiotic stewardship.

 

MeMed US Inc.
Host-protein Test and POC Platform for Distinguishing between Bacterial and Viral Infection in 15 Mins
Eran Eden

The following clinical scenario occurs daily: a child (or adult) presents to the physician’s office or emergency department with symptoms of an acute infection. Is it a bacterial or viral infection – to treat or not to treat with antibiotics? This seemingly simple dilemma arises because bacterial and viral infections are often clinically indistinguishable and current diagnostics have limitations.

Over the last decade, in collaboration with leading clinicians around the globe, MeMed has developed and validated MeMed BV™ – a pioneering test for distinguishing between and viral infections. It goes beyond pathogen detection by relying on the most accurate detection system – the body’s immune system – and is based on the circulating levels of three proteins generated naturally by the body that change expression in response to acute infection (TRAIL, IP-10 and CRP). MeMed BV™ has the potential to transform patient management by supporting physicians to make better informed antibiotic treatment decisions and tackle antimicrobial resistance (AMR) – a global healthcare threat and the topic of this challenge. MeMed BV™ is the only test for distinguishing between bacterial and viral infections that has been both double-blind and externally validated in clinical studies enrolling thousands of patients. Concurrently, to allow MeMed BV™ to be used where and when it actually matters, we have been collaborating with academic and commercial partners around the globe to develop MeMed Key™. A first of its kind, benchtop, easy-to-use immunoassay platform, MeMed Key™ opens the way to measuring multiple proteins with central lab performance at the point-of-need. Running MeMed BV™ on MeMed Key™ is our solution to the AMR diagnostic challenge.

 

MicroInvestigate
The Miki: a Direct-to-Consumer Advanced Molecular Diagnostic Device
Megan Nelson

Patients are increasingly involved in their own healthcare: from Teladoc to UberHealth to home glucose monitoring or pregnancy testing. However, despite the genomic revolution and 23andMe, no patient-facing genomic diagnostic for common infectious disease has yet entered the market. MicroInvestigate is developing a fully automated robotic kiosk for sample processing and detection of both pathogens and antimicrobial resistance genes. This fully automated diagnostic system will allow ‘drop and go’ sample deposition, yielding a report which will be accessible by the patient through their healthcare portal and their physician within 20-30 minutes. We will develop this system in partnership with the Student Health Center at American University, but the market reaches far beyond university campuses to any situation in which advanced molecular diagnostic information is needed: at field sites, in CVS Minute Clinics, airports, even military bases, and as kiosks are deployed they will yield real-time data on disease spread and outbreaks.

 

Nicholson Science
Pheromone Enhanced Disease Resistance, Pheromone Curtaining of Symptoms
Bubba Nicholson

Provide about 10mg of healthy adult male facial skin surface lipid pheromone on ordinary, fresh, new, un-chewed chewing gum to diagnose behavioral and autoimmune diseases.  The paternal pheromone on chewing gum vehicle when chewed thoroughly cures criminal behavior, delinquency, borderline personality disorder, ADHD, ADD, Conduct Disorder, PTSD, OCD, onychophagia, opioid addiction, sexual perversions such as homosexuality and child molestation, Tourette’s (improvement), Alzheimer’s (improvement), Parry-Romberg Syndrome (improvement), Hashimoto’s Thyroiditis (improvement), anxiety disorder, and others.  A mouth rinse with ethanol cuts most of the components, so a mouth rinse with a small amount of Listerine works.  Wine also works, swallowing the pheromone is OK because most of the components are too long to be digestible. Determine the patient’s reaction of relief and joy as positive, provide more pheromone, in the same manner, to cure for two years.  We need the money to fund phase 2 & 3 experiments per our FDA IND#138202, now on full clinical hold.

 

Qvella, Corporation
Qvella’s Integrated FAST-IDxTM System for Direct Pathogen ID and Host-Response-Based Infection Status
Susan Novak-Weekley

Technologies for rapid microbial pathogen identification and host response characterization are urgently needed to improve management of patients with life-threatening organ dysfunction suspected of sepsis.  Qvella is addressing this unmet need through its transformative FAST-IDxTM Infection Diagnosis (IDx) system, which combines the FAST-IDTM BSI Panel (Blood Stream Infection) and FAST-HRTM (Host Response) assay for rapid pathogen identification and host response-based infection status, respectively.  Thus, the FAST-IDx system provides the first integrated solution that combines rapid pathogen detection and infection status determination in a single platform. Both the FAST-ID BSI Panel and the FAST-HR assay rely on Qvella’s innovative and patented Field Activated Sample Treatment (FASTTM) platform technology for sample processing. The FAST technology platform leverages Qvella’s integrated centrifugal pathogen separation and concentration method and also utilizes Qvella’s e-Lysis™ electrical-based pathogen lysis method providing PCR-ready nucleic acids without the need for typical extraction and purification methods. The FAST technology platform has also been shown to facilitate efficient host mRNA separation and amplification with unprecedented precision, thereby enabling host-response gene expression assays with strong discrimination and high clinical utility.  Combining the FAST-ID BSI Panel with the FAST-HR assay provides a novel and highly impactful approach to diagnosis of a patient’s infection status. FAST-IDx is designed for whole blood, and is also adaptable for a broad range of other sample types, such as cerebrospinal fluid, urine, sputum, pleural fluid, etc.  Qvella’s fully automated, walk away FAST-IDx system is ideally suited for point-of-need settings such as emergency rooms and intensive care units, minimizing specimen transport time and delay in diagnosis.

 

RPS Diagnostics
FebriDx – A Rapid Point-of-Care Diagnostic Solution for Outpatient Antibiotic Stewardship
Robert Sambursky

RPS Diagnostics (RPS®) is an emerging developer, manufacturer, and marketer of cost-effective point-of-care (POC) tests for systemic infectious disease and antibiotic stewardship. The company’s innovative and patented FebriDx® test is a rapid, disposable, in-office test that incorporates an all-in-one retractable safety lancet, blood collection and transfer tube, and push button buffer activation mechanism, and produces results that identify a clinically significant host immune response. By simultaneously detecting elevations in Myxovirus resistance protein A (MxA) and c-reactive protein (CRP) directly from fingerstick peripheral whole blood, FebriDx can aid in the differentiation of bacterial from viral causes for fever in acute respiratory infection. With a 97-99% negative predictive value, FebriDx delivers results in 10 minutes or less and can be used to help triage infectious patients during the initial office visit, support workflow constraints, and provide clinicians with actionable information that can be used to limit unnecessary antibiotics. The FebriDx test is simple to perform and has received HealthCanada approval, Saudi Arabian FDA clearance, Singapore HAS registration, and is CE marked for sale in Europe. At this time, the FebriDx test has not received U.S. Food and Drug Administration (FDA) clearance and is not commercially available in the United States. For more information, visit RPSdetectors.com or FebriDx.com.

 

Rutgers University
MZO Nanostructure-Modified Bulk Acoustic Wave Biosensor for Dynamic and Rapid Determination of Antimicrobial Efficacy and Resistance
Yicheng Lu

We have invented the novel magnesium zinc oxide nanostructure – modified bulk acoustic wave (MZOnano-BAW) sensing system as a diagnostic tool to mitigate antimicrobial resistance (AMR).   By integration of a BAW device and MZO nanostructures, the MZOnano BAW biosensors possess the unique advantages over the existing technologies. The conventional methods employed in screening antimicrobial susceptibility heavily rely on monitoring the growth of live microbial cells.  It is typically handled through manually intensive assays; therefore is time consuming.  Our technology features dynamic and automated operation, rapid monitoring, labelfree, high sensitivity through surface modified MZO nanostructures, biocompatibility to various cell lines and biomolecules, compact and low cost, and wireless operation capability, enabling rapid detection of bacterial and dynamic monitoring of antibiotic susceptibility and resistance. The preliminary results have demonstrated the proof-of-principle and feasibility in rapid monitoring antimicrobial susceptibility and resistance of clinically-relevant bacterial strains. In future embodiments, miniaturization of the BAW sensors will lead to the sensing array on a chip that provides high throughput diagnostics and interface with the wireless portable systems. The technology will help drastically improve the timely decision-making on proper drug treatment, and more importantly, prevent the spread of antibiotic resistant strains. Such a diagnostic device can be used in clinical microbiology laboratories, hospitals/healthcare centers, and antimicrobial research and develop settings. We anticipate that this disruptive innovation will significantly improve treatment for infected patients and surveillance for AMR pathogens.

 

Sensor-Kinesis Corporation
Sensor-Kinesis Corporation’s SKC SAW Rapid Point-of-Need Pathogen Identification
Robert Purnell

When a patient presents with a potentially antimicrobial-resistant pathogen, administration of the incorrect antibiotic will have no therapeutic effect, while the patient continues to suffer. In other cases, an overly aggressive treatment will unnecessarily expose the patient to powerful antibiotics that will leave long-term organ damage. Recognition of particular strains of bacterial pathogens will make possible the selection of an appropriate treatment regimen, and prevent use of antibiotics that could unintentionally strengthen the pathogen’s resistance. Sensor-Kinesis Corporation (SKC), a development-stage biomedical technology firm developing portable biosensor systems, proposes the use of the Surface Acoustic Wave (SKC SAW or SAW) diagnostic device to detect bacteria, other pathogens, and biomarkers relevant to antimicrobial resistance, with a target recognition time of ten minutes or less. The SKC SAW system being developed is portable, the size of a smart phone, with inexpensive disposable cartridges for identification of bacteria, viruses, biomarkers, proteins, and human cells. This technology will place fast, powerful laboratory recognition of infectious agents into the hands of health workers in settings from hospitals to the developing world, guiding the appropriate treatment and combating the spread of antimicrobial-resistant disease.

 

Seraph Biosciences
Intelligent Raman Spectroscopy Based Identification of Antibiotic Resistant Bacteria
Gregory Auner

Seraph Biosciences was formed to produce quality, cost-effective technologies for health care providers to optimize clinical decision making. The global rise in antimicrobial resistant bacteria (AMR) is the most important public health crisis of our time. Overuse and misuse of antibiotics is the major cause of the increase in antibiotic resistant bacteria. Consequently, strains of bacteria that are resistant to an entire class of antibiotics are emerging. Seraph Biosciences has developed the Seraspec®- a fully integrated specimen handling, optical characterization and Raman spectral analysis instrument for direct agnostic interrogation of biological specimens. By leveraging the principles of Raman Spectroscopy, this portable, point of need technology effectively eliminates the requirement for time-consuming and costly laboratory-based methods of specimen collection and processing. This unbiased culture free technique does not require the use of predetermined primers and probes for detection. The Seraspec® allows for real-time Raman spectral measurements that generate a unique molecular fingerprint for pathogen identification. The use of proprietary signal processing and identification algorithms facilitates real-time identification of bacteria, bacterial toxins, and virus directly from patent samples (such as urine, nasal swabs and blood). Simply load the sample into a disposable cuvette, place inside of the instrument, and obtain result. The system also provides automated antibiotic susceptibility testing with results in 30 minutes to 1 hour (as opposed to days with current methodologies). This provides clinicians with evidence-based information at the point of care, enabling patient-specific antimicrobial treatment. This is especially significant for combating newly resistant strains. Seraph Biosciences has successfully: 1) demonstrated the technology can detect and identify bacteria inoculated nasal swab samples and urine at clinically relevant concentrations (>5000 c/ml), 2) demonstrated the capability of the technique for antibiotic susceptibility testing using an array of resistant and non-resistant strains of bacteria, 3) demonstrated the ability to detect C. difficile toxins, TcdA and TcdB, in spiked human blood serum samples, and 4) demonstrated unique markers that separate bacteria signatures form virus (H1N1 and H2N3). Seraph Biosciences has partnered with FDA- and ISO-standard certified hardware and software manufacturers to transition to full-scale production. As part of the AMR Challenge, we plan to complete analysis and library of antibiotic resistant and susceptible strains of  E.faecalis, K.pneumoniae, E.Coli, S.aureus, C.difficle, N.gonorrhoae, P.aeuginosa, and Tuberculosis, as well as virus samples Adenovirus Type 7 (h), Human Influenza A (i), Human Influenza virus B (j), Human parainfluenza (k), Human metapneumovirus (l), Respiratory syncytial virus Type B (m) and Rhinovirus to our testing panel and to perform extensive testing in confounding background matrix such as blood, urine, nasal, and throat swab samples as specified by FDA during Pre-IDE and formal submissions.

 

Spectral Labs, Inc.
Tools for Rapid-Point-of-Need Characterization of Bloodstream Infections that Enables Antimicrobial Stewardship on Uninfected Patients and Narrowly Tailored Therapy on Infected Patients
Ravi Verma

We propose the InSpector test suite, which is a combination of hardware and consumable reagent to characterize patients who are symptomatic of bloodstream infections.  The rapid tests detects and characterizes pathogenic microorganisms with high sensitivity and specificity.  The presence/absence of pathogenic microorganisms is characterized within 30 minutes of a blood draw, thereby informing antimicrobial stewardship on uninfected patients.  For infected patients, the tests phenotypes the pathogen and characterize its response to 7 candidate antimicrobials, thereby enabling narrowly tailored therapy ~ this information is available 4 hours after blood draw.  We have previously developed and validated this test through a series of pilot studies of human patient samples, and are now setting up studies that will help validate potential impact on sepsis.  Given the completeness of our test, and the potential positive impact on sepsis, we believe it will be adopted by laboratory directors and by clinicians, and will thereby help empower antimicrobial stewardship on uninfected patients.  This will reduce antimicrobial resistance AMR development.

 

University of Southern Florida
Precise Antibiotic Prescription Based on Rapid Isolation of Bacteria Followed by Antibiotic Susceptibility Testing
Anna Pyayt

In the United States alone, at least 2 million people become infected with antibiotic-resistant bacteria, and at least 23,000 people die each year as a direct result of these infections. In order to increase patient’s chances for survival and minimize the rapid spread of antibiotic resistance it is critical to promptly identify the bacterial pathogen and prescribe the most efficient antibiotic. Here we propose a transformative system for precise and personalized antibiotic prescription. We demonstrate a novel way to rapidly isolate bacteria present even in low concentrations from the biological samples using thermo-plasmonics. It can powerfully, but gently, move, concentrate, and capture bacteria from biological samples without any mechanical, photo, or thermal damage. After that, using microfluidics and Raman spectroscopy in combination with machine learning, preconcentrated bacteria can be directly analyzed for susceptibility against different antibiotics, followed by the prescription of the most promising antibiotic. This precise, personalized approach will first help to promptly determine if a patient is suffering from a bacterial infection or not without need for time-consuming culturing, and only then prescribe the most efficient antibiotic targeting recognized bacterial species. This will greatly help to fight antibiotic misuse in cases of viral infections. Additionally, the antibiotic susceptibility test will help to identify drug resistance of the isolated pathogens to some of the commonly prescribed antibiotics, and will help to avoid inefficient treatment. Overall, it can be a great addition to antibiotic stewardship programs by greatly improving the way of how antibiotics are prescribed, and also make treatment more personalized and precise.

 

Velox Biosystems, Inc.
Rapid Antimicrobial Susceptibility Test for Urinary Tract Infection (UTI) in Outpatient Settings
Tim Abram

Urinary Tract Infections (UTIs) are among the most prevalent bacterial infections affecting nearly 50% of the population at least once in their lifetime (especially for women, elderly, the obese and diabetics), accounting for approximately $3.5 billion in healthcare costs in the U.S. alone. The combination of high prevalence, a high false positive rate of current diagnostic modalities, and the lack of a point-of-care Antibiotic Susceptibility Test has led to significant overuse and misuse of antibiotics, contributing to a rapid increase in antibiotic resistance in UTI. By leveraging the sensitivity of scanning fluorescence correlation spectroscopy and the speed of their 3D rapid scan platform technology, Velox Biosystems has developed a highly accurate point-of-care device for rapid UTI Screening (results in 10 minutes) and phenotypic Antibiotic Susceptibility Testing (results in 2 hours) in the outpatient setting. Furthermore, Velox has generated exciting clinical feasibility data demonstrating a significant advance in UTI diagnostic accuracy and strong performance of rapid Antibiotic Susceptibility Testing. This approach has been validated in an in-depth survey with clinicians where Velox received overwhelmingly positive feedback. Clinicians strongly agree that the Velox product would provide significant value and could become a standard of care in the UTI point-of-care diagnostic space. With a very strong multidisciplinary team, a highly promising and practical point-of-care product that addresses a high prevalence and urgent clinical need, and significant progress already achieved to-date (with functional prototypes and clinical feasibility data), Velox Biosystems is highly motivated to address this critical gap and help physicians make judicious antibiotic treatment decisions to mitigate and control the continuing rise of antibiotic resistance in UTI.

 

YST Diagnostics
A Culture-Free Platform for Rapid Detection, Identification and AST of Bacterial Infections
Siu-Tung Yau

A culture-free platform will be developed for the rapid detection, identification and AST of bloodstream infections.  The platform with its multi-channel capability will simultaneously detect and analyze multiple bacteria and multiple samples to provide diagnostic information on 14 bacterial species in whole blood with a time-to-result of less than 120 minutes.

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