PRESS RELEASE: TGV-Dx Announces Study Results Showing AtbFinder as Novel Paradigm for Rapid Antibiotic Susceptibility Testing for Multidrug-Resistant Infections

TGV-Dx, Inc, a development-stage in vitro diagnostics company developing advanced systems that improve selection of antibiotic therapies, has announced the results of a study on its lead diagnostic platform, AtbFinder®. The study on the advanced test system for optimal antibiotic therapy for people with severe pulmonary infections was published in the Journal of Clinical Microbiology.

The real-world study compared data and patient outcomes before and after implementation of the AtbFinder for the most hard-to-treat lung infection caused by multidrug-resistant pathogens in subjects with cystic fibrosis. As data showed, AtbFinder had successfully guided physicians to select the most effective antibiotic therapy that eradicated highly antibiotic resistant Pseudomonas aeruginosa bacteria, which led to decreased hospitalizations along with a two-fold reduction in systemic antibiotic therapy and enhanced overall patient outcomes.

AtbFinder is fundamentally different from other antimicrobial susceptibility tests as it, for the first time, selects antibiotics that target the entire bacterial community. The test offers a unique combination of culture-free phenotypic testing with unprecedented specificity and accuracy of antibiotic selection directly from the patient clinical sample. AtbFinder is an all-in-one prefabricated kit that screens 188 antibiotics and their combinations per patient sample and delivers results within just four hours, compared to up to 72 hours for conventional phenotypic tests. 

“While there are certain innovations in diagnostics for patients with sepsis, for patients with respiratory, skin-and soft tissue and urinary tract infections, the technology used now was developed in late 1980s. Since then, the rate of ineffective antibiotic selection has been increasing, and is approaching 40% for some diseases, which is believed to contribute to higher mortality rates,” said George Tetz, a scientific founder of the project. “AtbFinder is a new era in antimicrobial susceptibility testing that can potentially save thousands of lives and reduce healthcare costs. We are working to make AtbFinder available to physicians and patients, already this year.”

As data showed, physicians using AtbFinder were able, for the first time, to select therapeutic regimens that eradicated Pseudomonas aeruginosa, which is increasingly resistant to antibiotics and persisted in patients for years, despite hundreds of attempted antibiotic courses. In addition, lung functioning exhibited over 27% improvement with AtbFinder® identified therapy compared to conventional intervention.

Furthermore, once patients switched to antibiotic therapy selected with the AtbFinder, they no longer required hospitalization due to pulmonary exacerbations, as compared to several annual hospitalizations needed when the antibiotic selection was guided by conventional tests.

AtbFinder® is based on a recent discovery of a Novel Biology in which cells interact with each other using a previously unknown receptor system discovered by professors Victor and George Tetz from the Human Microbiology Institute in New York City.

“We are very excited that AtbFinder based on novel principles for antibiotic selection demonstrated such groundbreaking results,” said Victor Tetz, a scientific founder of the project. “Other tests ignore complex interbacterial interactions at the site of infection, which are the most critical in terms of antibiotic response prediction. In its selection of antibiotics, AtbFinder for the first time considers the interaction of not only the leading bacterial pathogens with antibiotics, but analyzes how the whole microbial community responds to the antibiotic assault. It’s like switching to a 3D image from 1 dimension.”

Scientists at TGV-Dx believe that these findings highlight the advantage of “targeting the entire microbial community ” to antibiotics utilized by AtbFinder for patients with severe and recurrent infections.

About TGV-Dx, Inc.

TGV-Dx, Inc. is an in vitro diagnostics company revolutionizing the way doctors select antibiotics. The AtbFinder® diagnostic test is an all-in-one prefabricated kit that is based on a new principle of antibiotic selection for patients with different bacterial infections. It delivers results within 4 hours, which is days faster than any conventional tests. The AtbFinder tests the largest menu of up to 188 antibiotics and combinations thereof, which is up to 15x more than conventional tests.

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PRESS RELEASE: FDA Authorizes the First At-Home Test for COVID-19 and the Flu

The Food and Drug Administration issued an emergency use authorization for the first at-home test that can simultaneously detect both COVID-19 and the flu.

With a shallow nasal swab, the single-use kit can provide results within 30 minutes indicating whether a person is positive or negative for COVID, as well as influenza A and influenza B, which are two common strains of the flu.

People 14 and older can generally perform the test on themselves, the FDA says. Those between the ages of 2 and 13 can get results with the help of an adult.

Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, called the test as a "major milestone."

"We are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs," Shuren said in a statement.

The test was developed by Lucira Health, a California-based company that was also the first to receive FDA approval for at-home rapid COVID tests back in 2020.

According to the FDA, in people showing symptoms, the Lucira home kit accurately detected 88.3% of COVID infections and 90.1% of influenza A infections. The test can identify influenza B in lab studies, the FDA said. But because there are not enough cases of the virus circulating in real-world settings, further testing will be required, officials said.

The FDA also warned that, similar to all rapid diagnostic tests, there is a risk of false positive and false negative results. The agency says individuals who test positive for COVID or the flu should take appropriate precautions and follow-up with a health care provider, while people who receive a negative result of either COVID or influenza B should confirm it with a molecular test preformed in a lab.

Individuals who test negative but continue to experience symptoms of fever, cough or shortness of breath should also follow up with their health care provider in case of other respiratory viruses, the FDA said.

The dual-purposed test comes after a surge of COVID, the flu and respiratory syncytial virus -- or RSV — that strained hospitals across the country last fall.

"The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses," the FDA said in a statement.

Over the past few weeks, COVID-related deaths and hospitalizations have begun to fall, according to the latest data from the Centers for Disease Control and Prevention. Similarly, rates of flu and RSV-related hospitalizations have been going down, the CDC found.

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PRESS RELEASE: Oxford University Scientists’ AI Diagnostic Test Accurately Identifies Known Respiratory Viruses in Minutes

Nicolas Shiaelis and Dr Nicole Robb, Oxford University scientists and co-founders of health tech company Pictura Bio, have developed a world-first diagnostic, test powered by artificial intelligence, that can identify known respiratory viruses such as influenza and COVID-19 within five minutes from just one nasal or throat swab.

Current tests are either lab based and time consuming or fast and less accurate. They are also limited, for instance, a lateral flow test only tests for one infection. This means illnesses are spread as infected people wait for results, or because they are unaware they are infected. These findings, published in peer-reviewed, scientific journal ACS Nano, demonstrate how machine learning can significantly improve the efficiency, accuracy and time taken to not only identify different types of viruses, but also differentiate between strains. This could help better control the spread of respiratory infections and alleviate pressure on the NHS and healthcare staff whilst reducing medical waste.

Shiaelis and Robb collaborated with the John Radcliffe Hospital to evaluate a new method that uses AI software to identify viruses. The ground-breaking testing technology combines molecular labelling, computer vision and machine learning to create a universal diagnostic imaging platform that looks directly at a patient sample and can identify which pathogen is present in a matter of seconds. Much like facial recognition software, but for germs.

Preliminary research demonstrated that this test could identify the COVID-19 virus in patient samples. But to develop this further, they wanted to determine if the test could be used to diagnose multiple respiratory infections.

In the study, researchers began by labelling viruses in over 200 clinical samples from John Radcliffe Hospital. Images of labelled samples were captured and processed by custom machine-learning software that is trained to recognise specific viruses by analysing their fluorescence labels, which show up differently for every virus because their surface size, shape and chemistry vary. The results show the technology is able to rapidly identify different types and strains of respiratory viruses, including flu and COVID-19, within five minutes and with >97% accuracy.

The scientists formed Pictura Bio to further develop this technology and are now looking for further investment to accelerate development and get it to the front line of healthcare.

Dr Nicole Robb, scientist and co-founder of Pictura Bio, comments: “Cases of respiratory infections in winter 2022/23 have hit record-breaking highs, increasing the number of people seeking medical help. This combined with the COVID-19 backlog, staff shortages, tighter budgets and an ageing population puts the NHS and its workforce under immense and unsustainable pressure.

“Pictura Bio’s simplified method of diagnostic testing is quicker and more cost-effective, accurate and future proof than any other tests currently available. If we want to detect a new virus, all we need to do is retrain the software to recognise it, rather than develop a whole new test. Our findings demonstrate the potential for this method to revolutionise viral diagnostics and our ability to control the spread of respiratory illnesses.”

Lead-author of the publication, co-founder and DPhil post-grad researcher at the University of Oxford, Nicolas Shiaelis, added: “It is inevitable that other COVID-like viruses will emerge. This reinforces the need for more advanced diagnostic testing technology so that we can reduce the impact of new viruses on public health and the NHS.”

The technology is now licensed by Pictura Bio which aims to turn the method into a diagnostic test by creating a dedicated imager and single-use cartridge for use in point-of-care testing, with limited input from the user. The team will also expand the number of viruses that the models are trained on and will eventually start looking at other pathogens, such as bacteria and fungi, in respiratory samples, blood and urine.

About Pictura Bio

Pictura Bio is a health-tech company that has developed the world’s first one-minute pathogen recognition platform. The software, like facial recognition for pathogens, is a universal testing platform, powered by AI, to provide accurate, digital imaging-based identification of infectious disease. The innovation encompasses two patented innovations - PIC-ID and IRIS. PIC-ID coats the lipid membrane whilst IRIS, a deep learning neural network, simultaneously analyses and classifies pathogens. It is a fundamentally different way of identifying ALL infectious agents and the company’s vision is to have a Lab in a Box for one minute testing on desktops in hospitals, GP surgeries and pharmacies around the world.

Pictura Bio’s solutions drive faster, simpler and more cost-effective testing than resource-consuming molecular diagnostics, changing how we treat disease. The technology will enable healthcare decision makers to revolutionise health care as we know it - bolstering the fight against antimicrobial resistance, reducing medical waste and limiting virus exposure.

PIC-ID and IRIS - the technology

The Pictura Bio team is focusing on packaging its PIC-ID technology into a simple desktop ‘lab in a box’, named IRIS (Instant Recognition Identification System) around the size of a domestic microwave, comprising a single-purpose high-powered fluorescent microscope and image capture and processing technology. This technology has reached proof of concept and is protected by patents and the team is now in the process of building the technology to scale this product for wider availability & adoption in the medical community. Today, PIC-ID is trained to spot enveloped viruses from respiratory samples, but the future holds boundless potential for how pathogens in samples are recognised.

The Neural Network is the database that IRIS checks against to identify a pathogen. This process ensures that as new tests and pathogens are learned by the network, it can be continuously rolled via a software update, instead of requiring new panels and the infrastructure to go with it.

Reference

Nicolas Shiaelis et al, Virus Detection and Identification in Minutes Using Single-Particle Imaging and Deep Learning, ACS Nano (2022). DOI: 10.1021/acsnano.2c10159

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PRESS RELEASE: FDA Clears 'Selux NGP System' for Rapid Antibiotic Susceptibility Testing

Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Next Generation Phenotyping (NGP) System — a rapid antibiotic susceptibility (AST) testing platform that provides targeted therapeutic results days faster than the current standard of care. 

The FDA clearance is for Selux Diagnostics' in vitro antimicrobial resistance test, which determines a bacteria's susceptibility to 14 specific antimicrobial agents on the Selux Gram-Positive Panel. Selux's NGP Gram-Negative panel is currently under review by the FDA. 

"This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance. Our groundbreaking Selux NGP System holds the potential to save lives and decrease overreliance on broad-spectrum antibiotics, a key factor contributing to the rise of superbugs. We thank all our employees, partners, and advisors who contributed to this tremendous accomplishment," said Steve Lufkin, CEO of Selux Diagnostics.

"We have been waiting for true innovation in AST technologies to deliver rapid results that are accurate according to the latest FDA guidelines and include newly approved antibiotics," said James S. Lewis II, PharmD, FIDSA, co-director of antibiotic stewardship at Oregon Health and Science University, and chair, CLSI Antimicrobial Susceptibility Testing Subcommittee. "I am enthusiastic that the Selux NGP System addresses these critical needs and will become an essential tool for directing personalized therapies for infected patients."

Experts predict that without a significant change in today's treatment options, deaths from superbugs will surpass deaths from cancer by 2050. Selux is confronting this global health crisis head-on by redefining the speed and performance of AST, the critical diagnostic test that informs personalized antibiotic therapy.

Acknowledgment

This platform has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800013C.

About Selux Diagnostics 

Selux Diagnostics is transforming patient care by accelerating the selection of personalized antimicrobial therapy for all Infectious Disease patients. This advance will save lives, shorten hospital stays, and combat the growing antibiotic resistance epidemic by decreasing the overuse of broad-spectrum agents. 

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PRESS RELEASE: Revolutionary Ten-Second Test for Early Detection of Periodontal Disease and Pathogenic Bacteria in Dogs, Cats

PDX BIOTECH LLC today announced the official launch of OraStripdx, a revolutionary rapid test that can detect active periodontal disease in dogs and cats in ten seconds, with no anesthesia or sedation required. Each easy-to-use test strip changes color based on the concentration of thiols in the patient’s oral fluid. When a veterinarian or veterinary technician glides OraStripdx along the gumline of a dog or cat, thiols in the oral fluid will cause the test strip to change color, with the concentration of thiols reflecting periodontal disease activity.

“Periodontal disease is an invisible infection that causes needless suffering for millions of dogs and cats, so being able to test it this quickly and find it in its earliest stages is a major advantage to pet owners and their healthcare providers,” said John Beran, CEO of PDX BIOTECH, the parent company of OraStipdx. “In addition to periodontal disease itself causing pain, early detection can also serve as a warning sign of more serious disease.”

The performance of OraStripdx has been documented in peer-reviewed studies published in journals such as the Journal of the American Animal Hospital Association, the Journal of Veterinary Science & Technology and the Canadian Veterinary Journal. PDX BIOTECH has obtained five patents, and more than 250,000 tests have already been shipped to veterinary practices around the world.

The Science Behind OraStripdx 

Approximately 85% of dogs and cats have periodontal disease. This chronic and progressive disease impacting multiple organ systems develops in the gingival sulcus, an anatomic compartment between the tooth and gum that cannot be visualized in the awake patient. PDX BIOTECH has developed technology to detect the development of disease where it cannot be directly visualized.

In dogs, cats, and even humans, the concentration of thiols in oral fluid is directly related to periodontal disease activity. Thiols, also called “volatile sulfur compounds” or VSCs, are structurally similar to alcohols but have a sulfur atom in place of an oxygen atom. In periodontal disease, the gingival sulcus becomes anaerobic as it deepens into a periodontal pocket. Each periodontal pocket harbors millions of pathogens. The most prominent of these pathogens are anaerobic bacteria that produce thiols as end-products of their metabolism. These pathogens degrade gingival tissue and alveolar bone, leading to loss of tooth attachment and, ultimately, cardiovascular, renal and hepatic sequelae.

The OraStripdx test strip is pre-treated with a thiol detection reagent. After the strip is glided along the maxillary gingival margin of a canine or feline patient, its color will reflect the concentration of thiols in the patient’s oral fluid. No color change means no detectable thiols and no active periodontal disease. Any color change reflects periodontal disease activity. The more intense the color, the higher the concentration of thiols, and the greater the periodontal disease. These visual results are easy for veterinary professionals to interpret and easy for clients to understand.

Advantages of Early Detection 

Early detection of any disease can help prevent pain and suffering, as well as further progression of the condition. In peer-reviewed studies, OraStripdx was found to be significantly more effective than the visual awake exam in detecting active periodontal disease. This early detection enables timely intervention to prevent disease progression which may otherwise lead to tooth and bone loss as well as debilitating and life-threatening co-morbidities including cardiovascular, renal, and hepatic sequelae.

Early detection with OraStripdx also increases client compliance with veterinarian recommendations. In one peer-reviewed study, published in the Journal of Veterinary Science & Technology, routine use of the test in every wellness examination led to the following increases in client compliance with veterinarian recommendations: 

- 54% for professional cleaning under anesthesia

- 57% for dental radiology

- 80% for dental home care products.

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PRESS RELEASE: ALiA BioTech’s One-stop Diagnostic Platform Brings Multiplex Testing to the Medical Front Line

Driven by the Covid-19 pandemic, the market for point-of-care testing (POCT) is seen to double in size compared to pre-pandemic levels. In this burgeoning field, multiplexing is the key technology differentiator. Increasing the number of simultaneous assays helps to identify the right biomarker, and thus reduces the cost and time it takes to quell any potential outbreak. ALiA BioTech group took on this challenge 10 years ago and is now ready to deploy a next-generation rapid diagnostic platform that can conduct multiplex testing in a single biochip within 15 minutes.

“It becomes very personal now,” said Kelvin Chiu, CEO. “Next time we sneeze or cough, we could be catching Covid-19, influenza, respiratory syncytial virus, or Streptococcus pneumoniae. A single test on our platform gives the fast track and accurate answer.”

ALiA’s Lab-on-Chip platform is a patented POCT that delivers up to 30 results from a single drop of body fluid, whether that be blood, serum, swab, or urine. Having completed research and development of its proprietary microfluidic and microarray technologies, ALiA is ready to scale up the manufacturing of multiplex products for different disease panels. The company’s pipeline will also direct POCT towards veterinary health and agri-food surveillance within the same platform.

ALiA analyser and its biochip panels for respiratory infection and tropical fever have obtained Europe’s CE marks, with the accredited ISO 13485 medical device quality management system.

The biotech firm is securing regulatory approval in other jurisdictions, including the United States, mainland China and Southeast Asia. The company anticipates global strategic partnerships in developing biochips for different disease panels and aims to deepen ties around product development and commercialisation. It also welcomes strategic partnerships to establish advanced manufacturing in the US, European Union and Asia-Pacific.

“Over the next five to 10 years, we shall develop more multiplex diseases panels and complete clinical trials and regulatory approval processes so that we can introduce more real-time rapid diagnostic panels that are critical to rescuing lives,” Chiu said.

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PRESS RELEASE: Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings

Visby Medical™ announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test. The Visby Medical Respiratory Health Test is a fast, polymerase chain reaction (PCR) device that detects and differentiates between upper respiratory infections caused by Influenza (Flu) A & B, and SARS-CoV-2 (COVID-19).

Visby Medical has created the first and only “instrument-free” platform that offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients.

Both the CDC and the Infectious Disease Society of America recommend clinicians should use rapid molecular assays (i.e., nucleic acid amplification tests) over rapid influenza antigen diagnostic tests (RIDTs) in outpatients to improve detection (https://doi.org/10.1093/cid/ciy866; https://www.cdc.gov/flu/about/burden/index.html). However, PCR testing has not been widely adopted in outpatient settings in part, because of the expense required to adopt and maintain PCR instrumentation. The instrument-free Visby Medical device solves this problem.

“Accurate, rapid, point of care testing can help physicians prescribe appropriate antiviral medications, minimize viral transmission in waiting rooms, and improve patient satisfaction,” said Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical. He further added, ”Use of the Visby Respiratory Health Test at the point of care in urgent care clinics and emergency rooms will transform how patients with respiratory symptoms are diagnosed and treated.” This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number

75A50121C00019.

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PRESS RELEASE: Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests

Accelerate Diagnostics has filed a 510(k) premarket submission for a gram-negative menu expansion and breakpoint updates for its Accelerate PhenoTest BC kit used for antimicrobial susceptibility testing.

A previous version of the test and the Accelerate Pheno system received US Food and Drug Administration clearance in 2017 for rapid pathogen identification and phenotypic antibiotic susceptibility testing. In 2021, the firm began selling a new configuration of the kit in the US and secured CE marking for that configuration. The Tucson, Arizona-based firm said its recent 510(k) submission includes escalation and de-escalation agents for gram-negative organisms, additional antibiotics for treatment of Acinetobacter baumannii infection, and breakpoint updates for existing susceptibility measures. It also includes oral antibiotic options for de-escalation, which can aid patient discharge planning.

The Accelerate Pheno system and BC kit provide fully automated sample preparation and results in about seven hours direct from positive blood cultures.

Accelerate CEO Jack Phillips said in a statement that the updated PhenoTest panel "adds meaningful new antibiotic choices for clinicians to minimize time to optimal therapy for patients with bloodstream infections."

"These additions and improvements will increase the value of the Pheno system in hospitals across the country, enhancing the clinical value labs have been experiencing for the past several years," he said.

The firm said in May it plans to launch and commercialize a new system for MALDI mass spectrometry and update its Pheno platform, with clinical trials of the Pheno II instrument planned for 2023. It also entered into a commercial agreement this August with Becton Dickinson, which will sell the Accelerate Pheno system and Accelerate Arc module for antimicrobial susceptibility testing.

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PRESS RELEASE: Thermo Fisher Scientific Launches TrueMark Infectious Disease Research Panels

Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TrueMark Infectious Disease Research Panels designed to enable rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases.

To effectively study outbreaks and determine disease etiology where pathogens are similar, analytically sensitive panels are needed to support laboratory research. TrueMark Infectious Disease Research Panels are analytically sensitive, real-time polymerase chain reaction (PCR) syndromic panels for the analysis of a wide range of infectious disease pathogens.

Leveraging real-time PCR technology, the predefined and customizable panel options allow researchers to choose from more than 90 different bacterial and viral strain assays to generate results within four hours from taking the samples.

“With the TrueMark Infectious Disease Research Panels, laboratories can choose either the readymade panels or create their own custom panels to suit their needs,” said Dr. Manoj Gandhi, senior medical director of Genetic Testing Solutions at Thermo Fisher Scientific. “By providing the flexibility to choose panels for researching polymicrobial infections, laboratories can now expand their testing menus using existing instrumentation and offer the benefits of PCR testing for researching a broad range of markers that can cause infectious disease.”

The assays use pre-spotted and dried down TaqMan plates, which are designed to enable easy set-up and increased accuracy. Testing can be done from nasopharyngeal swabs or nasopharyngeal aspirate, vaginal, genital and lesion swabs or urine samples. These samples can also be prepared using workflows that currently exist in most labs that use the Applied Biosystems MagMAX Viral/Pathogen kits automated on a KingFisher Purification System instrument and mixed with the Applied Biosystems multiplex master mix onto a 96-well or 384-well plate.

The panels are optimized for use on QuantStudio qPCR systems with verified sample-to-answer workflow and provide easy to read results with the Applied Biosystems QuantStudio Design and Analysis Software v2.6.

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