PRESS RELEASE: T2 Biosystems Announces FDA 510(k) Submission to Expand Pathogen Detection on T2Bacteria Panel for Acinetobacter baumannii

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the number of pathogens detected on the FDA-cleared T2Bacteria® Panel to include the detection of Acinetobacter baumannii (A. baumannii).

A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock. In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of 34.0% to 43.4%. A. baumannii infections typically occur in people in healthcare settings and pose risk to those who are on ventilators, have devices such as catheters, have open wounds from surgery, are in intensive care units, or have prolonged hospital stays.

“We are excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel to include the detection of A. baumannii,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe the addition of A. baumannii will lead to increased adoption as it increases the detection capabilities of our FDA-cleared T2Bacteria Panel to approximately 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.”

Due to the emergence of pan-antibiotic resistant A. baumannii, the World Health Organization has identified A. baumannii as the most critically important bacteria that requires improved prevention and therapeutic approaches. There are few antimicrobial options for carbapenem resistant A. baumannii, which can increase mortality rates to 70%. Acinetobacter resistance to many antibiotics, including carbapenems, highlights the importance of rapid detection and targeted antimicrobial treatment.

The T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in 3 to 5 hours, without the need to wait days for a positive blood culture. The FDA-cleared T2Bacteria Panel currently detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli, and the CE marked version detects the aforementioned pathogens plus A. baumannii. Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes. 

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PRESS RELEASE: Opteev to Debut Multiplex Biosensor that Detects and Identifies Virus and Bacteria Pathogens in Under 60 Seconds

Opteev Technologies, Inc., a Baltimore-based pioneering technology company at the forefront of diagnostics, will be debuting its groundbreaking multiplex biosensor at the BIOMEDevice medical device expo in Boston on Wednesday, September 20th. Opteev’s impedance-based biosensor is capable of detecting and differentiating an extensive array of virus and bacteria pathogens in a single test in an astonishing 60 seconds with over 99% accuracy.

The biosensor achieves fine-tuned specificity by carefully selecting specific organism-binding peptides, enabling accurate identification of bacteria and viruses in complex samples. 

The company’s novel device offers a complete paradigm shift in healthcare, environmental monitoring, food safety, and at-home testing. In healthcare, the lightning-fast biosensor paves the way for the first comprehensive syndromic multiplex testing available at the Point of Care, enabling doctors to remove diagnostic guesswork so they can provide targeted treatment in real time. Furthermore, the technology grants air purifiers and HVAC systems the advanced functionality of identifying harmful pathogens to trigger immediate purification, affords rapid identification of foodborne pathogens from supply chains to home kitchens, and provides comprehensive diagnostics for at-home testing. Moreover, its adaptability to detect novel viruses upon receiving genetic sequencing data presents public health agencies the ultimate tool for surveillance and containment of future outbreaks.

“Imagine a world where over 70% of medical decisions aren’t mere educated guesses. That’s the change our biosensor brings to healthcare,” emphasized Dr. Mesfin Meshesha. “No longer will comprehensive diagnostics be a waiting game or a matter of affordability. And its impact resonates far beyond the walls of a clinic. Whether it’s ensuring the air we breathe is safe or providing society a fortified way of defending against future pandemics, our innovation ushers in a new era that will set the benchmark for decades to come.”

Conrad Bessemer, Opteev’s Chairman and Co-founder, further emphasized the disruptive potential of the technology: “BIOMEDevice Boston serves as a platform for us to not only introduce our novel biosensor but also to invite potential collaborators to join us. Together, we’re poised to reshape diagnostics and maximize the unprecedented potential of our technology.”

For a closer look at this revolutionary device, Opteev will be exhibiting its Multiplex Biosensor at the BIOMEDevice Boston event at the Boston Convention and Exhibition Center on Wednesday, September 20th and Thursday, September 21st at Booth #945.

As the company continues to advance diagnostic innovation, Opteev welcomes discussions on collaborations and partnerships, emphasizing a shared vision for the future of pathogen detection and infection diagnostics.

About Opteev Technologies, Inc.

Opteev Technologies, Inc., headquartered in Baltimore, MD, is an innovative technology company at the forefront of diagnostics. A subsidiary of Novatec, Inc., Opteev combines deep expertise and an unwavering commitment to push the boundaries of rapid pathogen detection and diagnostics.

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IIT Guwahati Develops Device for Fast Detection of Urinary Tract Infection

The researchers at the Indian Institute of Technology (IIT) Guwahati have developed a 3D printed cost-effective device to detect specific bacteria that causes urinary tract infection (UTI).

It is a fast, accurate, and reliable device that can measure and identify the type of bacteria in a UTI suspected patient, the institute said in a statement.  

The estimated cost of manufacturing this device is ₹ 608, while testing a single sample will cost ₹ 8 only, it said

The institute said it is cost-effective and can also be used by people in rural areas, where most UTI cases remain undetected due to lack of adequate testing facilities.

This device can measure and identify the type of bacteria in a UTI suspected patient in 5 minutes while other testing devises use urine culture that requires a few days.

While explaining the significance of their Research, Dr Partho Sarathi Gooh Pattader, Associate Professor, Department of Chemical Engineering, IIT Guwahati said, "Early-stage detection of UTI is important to provide timely treatment. The Point-Of-Care Testing (POCT) prototype developed at IIT Guwahati is a photodetector that detects and quantifies a specific UTI-causing bacteria called 'Klebsiella pneumoniae' within five minutes from a patient's urine sample."

He said the detection of 'Klebsiella pneumoniae' is important not only because this bacteria is responsible for UTI, but also for pneumonia and for the infection of soft tissue.

Post a comment Elaborating on the mechanism, Dr Pattader said, "We have used gold nanoparticles with specifically-engineered aptamers. An aptamer is like a 3D puzzle piece that fits only on the surface of a particular bacteria. The gold nanoparticles thus get agglomerated on the surface of the target bacteria giving out a unique signature that can be detected by a UV- Visible Spectrophotometer."  

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PRESS RELEASE: DCN Dx & BIOASTER Announce Collaboration for Development of Multiplex Rapid Diagnostic for Neglected Tropical Diseases

DCN Dx, a global leader in the end-to-end development, manufacturing, and commercialization of point-of-use tests, and BIOASTER, the French Technology Research Institute focusing on microbiology and infectious diseases, announced a collaboration as part of a second grant to BIOASTER for onchocerciasis diagnosis from the Bill & Melinda Gates Foundation.

Onchocerciasis, also known as river blindness, stands as the second leading cause of infectious blindness worldwide. According to estimates by the World Health Organization (WHO), approximately 25 million people are infected globally, with another 90 million at risk. Over 99% of these cases occur in Africa, and vision loss affects around 1.15 million individuals.

This project follows a first grant awarded to BIOASTER in 2019. The main goal is to enhance the specificity of the Ov16-rapid test, especially in relation to Loa loa and Mansonella perstans helminths, to achieve the 99.8% specificity as recommended by the WHO Diagnostic Technical Advisory Group (DTAG). This test would support onchocerciasis elimination and evaluation of preventive chemotherapy programs.

In partnership with the Laboratory of Parasitic Disease (NIAID) and DCN Dx, BIOASTER aims to develop an advanced multiplex lateral flow assay for detecting Onchocerca volvulus antibodies in human blood. This diagnostic tool will incorporate a combination of innovative and complementary O. volvulus antigens. The selection and evaluation of these antigens will take place at BIOASTER.

The diagnostic performance of the test will be assessed using onchocerciasis specimens and other parasitic helminths collected in the field and characterized under the supervision of Pr. Joseph KAMGNO at the Higher Institute of Scientific and Medical Research in Yaoundé (ISM), Cameroon (www.ismcm.org).

Xavier Morge (CEO, BIOASTER) noted, “We are proud that the Bill & Melinda Gates Foundation has continued its support as we aim to improve onchocerciasis diagnosis in the coming years.”

“This new grant from the Bill & Melinda Gates Foundation is a great example of BIOASTER's commitment to accelerate the development of a lateral flow test with high specificity for the diagnosis of onchocerciasis,” said Cyril GUYARD (CSO, BIOASTER).

Patrick Vaughan (COO, DCN Dx) expressed enthusiasm about the collaboration, stating, “We are delighted to partner with BIOASTER's scientific team to transform their key O. volvulus antigen research into a user-friendly and highly specific lateral flow test to advance onchocerciasis diagnosis.”

“DCN Dx’s core purpose extends beyond the technicalities of diagnostics," Mitzi Rettinger (Chief Revenue Officer, DCN Dx) explained. "We're striving to make a real difference in global health, and our partnership with BIOASTER on this vital project exemplifies that mission. By accelerating the development of a cutting-edge multiplex rapid test for African river blindness, we're making a tangible contribution to a world with less suffering from this devastating disease."

About BIOASTER

Created in 2012, following the French initiative of Technology Research Institutes, BIOASTER is a not-for-profit foundation developing a unique technological and innovative model to sup-port the latest challenges in microbiology. In particular, BIOASTER uses and develops high value technological innovations that accelerate development of medical solutions for populations and personalized medicine. The aim of BIOASTER is to bring together academic, industry and its capacities and specific knowledge to develop and execute high impact collaborative projects requiring industry compatible innovative technologies.

About DCN Dx

DCN Dx, based in Carlsbad, California, is a global leader in IVD CDMO and CRO services. Our multidisciplinary team specializes in creating tailored assay systems, consumables, and instruments for point-of-use applications, with a particular expertise in lateral flow assays.

Our personalized approach to IVD product development has supported more than 560 programs from over 260 clients. We can oversee every stage from concept to assay development and platform integration, through clinical trials to manufacturing or only handle the aspects you request. In addition to lateral flow assays, our clinical research expertise extends to a wide range of IVD devices, all with a focus on innovation, usability, and performance.

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PRESS RELEASE: Charles River Introduces Animal-Free Endotoxin Testing with a Recombinant Cascade Reagent (rCR)

For decades, the biopharmaceutical industry has trusted us to listen and react to the unique manufacturing challenges parenteral manufacturers face bringing products to market.

With insights and product feedback fueled by the industry, our optimized Endosafe® bacterial endotoxin testing solutions continue to make mandatory safety testing faster, easier, and more reliable. As we navigate the intricate relationship between nature, science, and human health, we recognize the importance of reducing our impact on the environment and embracing ethical practices in pharmaceutical, vaccine, and medical device development.

As a result of our commitment to innovation, the 3Rs, and sustainability, we’ve refined the next addition of our Endosafe bacterial endotoxin detection portfolio by introducing Endosafe Trillium, a robust recombinant cascade reagent (rCR) assay designed for sustainable progress.

Trillium detects and quantifies natural environmental endotoxins as well as endotoxin standards (RSE & CSE) by simulating the natural LAL enzymatic cascade through an optimized formulation and composition of three critical recombinant proteins (Recombinant Factor C, Recombinant Factor B, and Recombinant pro-clotting enzyme). This proprietary matrix demonstrates assay superiority in accuracy, comparability, and robustness compared to other recombinant endotoxin detection technologies, and has been proven to ensure its equivalency to LAL.

In addition to being 100% animal-free, Endosafe Trillium rCR offers a host of benefits that will transform your endotoxin testing program. 

· A kinetic chromogenic method, it is compatible with existing incubating absorbance plate readers.

· 3-Factor enzymatic cascade simulates the same cascade reaction as traditional LAL.

· Eliminates the potential for 1,3-β-D-glucans, reducing the risk of false positives.

· Quantitative range: 0.001 to 100EU/mL

· Primary validation package includes protocols, summary report, and implementation support.

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PRESS RELEASE: Multiomics Biosignal Detection in Real-Time via an Electronic Biosensor

DARPA (Defense Advanced Research Projects Agency), Siemens, US ARMY, Georgia Tech Research Institute, and Paragraf - through recently acquired Cardea Bio, now Paragraf San Diego - presented novel multiomics capabilities, by detection of both protein and RNA biosignals simultaneously on a single graphene-based biosensor. 

This scientific breakthrough was recently published as a cover story in Advanced Materials Technology, marking the first public demonstration of this novel methodology for multiomics. The paper, A Single Multiomics Transistor for Electronic Detection of SARS-Cov2 Variants Antigen and Viral RNA Without Amplification, is the first in the world demonstrating the capability to detect both protein and RNA biosignals in a COVID-19 based experiment where both the COVID wild type as well as the Omicron variant were successfully detected.

Dr. Kiana Aran, Chief Innovation Officer at Paragraf San Diego, states; "Having a single technology platform that can detect both protein and DNA/RNA biosignal analytes at the same time on a small-scale detection device, is a major technological advancement. While it initially will impact when and where we can detect viral infections, with time it will also work for other types of diseases. This will enable new, better, and way faster diagnoses for any types of diseases or biothreats."

Dr. Simon Thomas, CEO at Paragraf adds, "This project was initiated during the COVID-19 pandemic to foster technologies that could be rapidly deployed to detect new diseases, envisioning a flexible multiomics point of care detection platform for any future pandemics. Together with partners, our Paragraf team in San Diego successfully completed this initiative accomplishing the goal set out by DARPA. More importantly, this novel breakthrough combined with Paragraf's unique ability to mass produce graphene-based electronics with standard semiconductor processes, marks the beginning of a new direction for what's possible in point of care testing."

"Up to this point, PCR has been the mainstay of DNA/RNA detection done at any scale. However, this technology has not been available as a convenient or rapid point of care resource. Along with that, antibody/antigen lateral flow tests are the go-to tools for rapid point of care protein detection, but on their own cannot provide the lab-level accuracy of PCR. The outcome of this multiomics project represents the first generation of a novel multiomics platform that – with comparable accuracy and specificity – can drive a new level of point of care disease detection. You can think of this as offering lab-level accuracy as well as the convenience and ease-of-use of lateral flow tests" concludes Dr. Tom Wilson, Chief Commercial Officer at Paragraf.

Paragraf's novel multiomics methodology is based on their BPU (Biosignal Processing Unit) platform and is currently available for Research Use Only. Paragraf is actively recruiting early access partners to develop new applications on the platform. Academic as well as commercial entities interested in learning more about the platform and potentially becoming a partner, please contact enquiries@paragraf.com

About Paragraf

Paragraf is the first company in the world to mass produce graphene-based electronic devices using standard semiconductor processes.

On May 2, 2023, it was announced that Paragraf Ltd acquired Cardea Bio, resulting in Paragraf San Diego. The bioassay and multiomics capability of the new Paragraf USA team combined with Paragraf's unique capability to mass produce graphene-based electronics at scale is a powerful enabler of new possibilities for lab-level accuracy with the ease of use, rapid detection, and convenience of lateral flow testing for applications in agritech and healthcare. 

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PRESS RELEASE: PathogenDx's New Rapid, Single Test Detects Salmonella and 13 Serotypes in Poultry

At a time when foodborne illness remains a significant threat to public health in the US, PathogenDx, a leader in next-generation microarray technology for better health and safety, announced the launch of SeroX, a new rapid, single test that detects Salmonella and 13 serotypes in a single shift to support the food industry’s poultry sector.

“Salmonella outbreaks are a huge issue facing poultry producers, particularly when you look at the astronomical risk and costs associated with an outbreak,” said PathogenDx Co-founder and CEO Milan Patel. “For every confirmed case of Salmonella, another 30 go undetected. In fact, the Centers for Disease Control and Prevention (“CDC”) estimates that each year one in six Americans – or 48 million people – get sick, 128,000 are hospitalized and 3,000 die of foodborne diseases. To make matters worse, food contaminated with Salmonella usually looks, tastes and smells normal. That’s why next-gen tests like SeroX are critical to preventing infection and minimizing this threat to public health in the US.”

Patel added, “With SeroX there is no need for qPCR, NGS testing or both. SeroX delivers advanced gene detection of Salmonella and 13 serotypes from primary enrichment, and ensures an easier, simplified workflow and cost savings that poultry producers require to optimize production and food safety. SeroX results are also ready in a single-shift and deliver the lowest cost per sample when compared to sequence and antisera based serotyping methods.”

PathogenDx’s SeroX Assays includes the Company’s patented Dynamic Dimensional Detection (“D3 Array™”) technology, which is comprised of up to 108 probes – in triplicate, in a single well – to deliver a new and innovative approach to multiplexed molecular testing. Amplified DNA binding is enabled easily across a flexible, open 3D cross-linked array architecture, which results in a more flexible, faster and lower cost test than qPCR or NGS technology. Additionally, SeroX rapidly detects the serotypes responsible for the vast majority of all harmful Salmonella infections in one efficient test.

About PathogenDx

Headquartered in Scottsdale, Arizona, PathogenDx is a leader in next-generation microarray technology for better health and safety. Its mission is to become the new standard in nucleic acid-based testing through widespread adoption of its advanced microarray testing platform for the human diagnostics, food and agricultural industries. PathogenDx’s technology can rapidly detect and identify up to 50 pathogens simultaneously, in a single test, in six hours providing triplicate data per analyte for certainty in results with a simple and easy process. The company’s DNA-testing products – Detectx™, Quantx™ and Envirox™ are disrupting the century old practice of Petri dish testing to detect, identify and quantify pathogens that threaten human health, our ecosystem and the environment. This technology will help growing businesses deliver safer products leading to healthier lives, while preventing billions of dollars in losses from infection and contamination. 

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PRESS RELEASE: Helsinki-based Solu Raises €1M to Combat Global Antibiotic Resistance with Pathogen Data Analysis

Antibiotic resistance is a growing global problem: the ability of pathogenic bacteria to resist antibiotics has increased in recent years, and their prevalence has accelerated. According to studies, antibiotic resistance directly caused over one million deaths worldwide in 2019, and nearly five million people died from bacterial infections that are resistant to antibiotics.

With that in mind, Solu, a Finnish biotechnology startup focusing on combating antibiotic resistance by building the world’s most extensive pathogen DNA library, announced its €1 million Seed funding round, led by Finnish early-stage investor Lifeline Ventures and joined by Wave Ventures. With the recent seed funding, Solu will continue its product development and commercialization. 

Solu’s product makes understanding, detecting, and preventing the spread of antibiotic resistance easier and enables real-time monitoring to detect dangerous mutations effectively.

“Antibiotic resistance is a significant threat to global health. Preventing antibiotic resistance requires better research and faster identification,” says Solu’s co-founder and CEO Sam Sihvonen.

Due to advanced DNA sequencing methods, data volumes have grown massively in antibiotic resistance research. However, analyzing vast amounts of data using existing methods is often slow and inaccurate. Solu enables more efficient bacterial data processing and real-time monitoring of changes in pathogens.

“We make the identification of antibiotic-resistant bacteria easy and fast. Typically, identification takes hours, but with our solution, it shortens to a few minutes. Real-time data can effectively detect superbugs and dangerous mutations, making it possible to stop their spread as quickly as possible,” says Sihvonen.

Founded in 2022, Solu has started collaborating with top international universities, including Stanford University and the University of Hamburg, which use Solu’s product in their research on antibiotic resistance.

According to its founders, beating antibiotic resistance requires world-class expertise and cross-industry collaboration. By working with universities, they also receive valuable feedback from international experts for product development. This helps them aim directly at global markets.

“Significant problems can be solved by bringing new technology bravely into existing industries. Solu combats antibiotic resistance with big data and user-friendliness. The team’s courage to tackle a global challenge, along with their ambition and significant partnerships, impressed us. We are excited to support Solu’s team early on in developing their groundbreaking solution,” says Timo Ahopelto, founding partner of Lifeline Ventures.

In the future, Solu aims to build the first pathogen DNA library that collects all pathogen data in real-time and can also model their evolution and identify new health-threatening pathogens more effectively.

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PRESS RELEASE: ReadyGo and Gemina Laboratories to Develop a Rapid Mycobacterium Tuberculosis Diagnostic Test

ReadyGo Diagnostics Ltd. (ReadyGo), a specialist in isothermal molecular diagnostics, today announced that it has entered into an assay development agreement with Gemina Laboratories Ltd. (Gemina), a Canadian company that specialises in fast, affordable and accurate diagnostic tests.

ReadyGo will develop, optimise and validate an assay for the detection of MTB for Gemina to run on ReadyGo’s off-grid isothermal diagnostic platform, Geo. The Geo platform provides rapid results in any location in under 30 minutes and is expected to play a crucial role in the diagnosis of MTB within near patient settings which would greatly improve patient management and outcome.

MTB is a highly infectious airborne disease. There were over 10 million MTB infections globally in 2021 resulting in 1.6 million deaths. In addition, it was estimated that 4 million infections (2 in every 5 cases) remain undiagnosed and patients do not access treatment which impairs the ability to control the disease. Diagnosis in low- to middle- income countries, where the disease is most prevalent, generally involves smear microscopy from sputum samples. However, there are significant limitations to these tests, especially in remote settings and in diagnosing certain patient demographics such as children and the elderly who have difficulties producing sputum.

The diagnosis of MTB is therefore a serious and challenging healthcare issue. The World Health Organisation (WHO) has recommended the use of molecular diagnostic tests which can accommodate the use of alternative sample types such as saliva which would make testing more accessible. ReadyGo’s partnership with Gemina aims to address these recommendations and provide a test that can replace smear microscopy with a simple saliva sample which would provide a sample to answer result anywhere within 30 minutes.

Brian Firth, CEO of Gemina, commented:

"I'm excited about our partnership with ReadyGo Diagnostics. Our goal at Gemina Labs is to create better diagnostic tests for respiratory diseases. We focus on tests that are effective at the front line of patient care whether that be in the field, the home or the primary clinic. For this reason we've been impressed by ReadyGo's platform, Geo and what it could mean for the diagnosis and treatment of tuberculosis. I'm really confident that by teaming up with ReadyGo, we'll be able to create a fast and accurate TB detection solution that can make a real difference in improving patient outcomes all around the world."

Ben Cobb, CEO of ReadyGo Diagnostics, added:

"I'm really excited about our partnership with Gemina to create a simple platform for diagnosing tuberculosis. Having worked in this field for a long time, I know that a low-cost triage tool that can replace smear microscopy is desperately needed, especially in places with limited resources. We are proud of the progress made so far, and we're committed to becoming the go-to development partner for companies looking to create simple, cost-effective molecular diagnostics for different settings." 

ReadyGo Diagnostics is a rapidly growing diagnostics company that designs, develops and commercialises novel sample collection devices and diagnostic platforms. Our proprietary technology molecular diagnostic platform, Geo, permits low cost decentralised testing in under 30 minutes. Snap™ transforms sample preparation by elegantly combining sample collection with sample processing into a single, user-friendly disposable to provide optimal and reproducible results using molecular, biochemical and lateral flow tests. Snapshot™ combines this sample collection and processing architecture with an integrated molecular test to provide an all in one solution for diagnostic testing.

About Gemina Laboratories Ltd.

Gemina Laboratories Ltd. is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, influenza and other viruses.

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PRESS RELEASE: Bruker Introduces New Mycobacteria and Fungi IVD Solutions for MALDI Biotyper®, and a Novel LiquidArray® Gastrointestinal Syndromic Panel

At the 33rd European Congress of Clinical Microbiology & Infectious Diseases (www.eccmid.org), Bruker Corporation announced its latest innovations for user-friendly, best-in-class diagnostic solutions for routine clinical microbiology and infection diagnostics laboratories.

1. Bruker introduces fast next-generation MALDI Biotyper® IVD Software

Microbial identification faster than ever: The MBT Compass HT IVD software provides a high sample throughput for microbial identification with time-to-result of ~5 minutes for 96 sample spots. Because of a fast sample target exchange, the MBT system can now analyze up to 600 samples per hour, while covering over 4,600 species in the reference library.

Microbial identification with optimal performance: The new IDealTune™, part of the MBT Compass HT IVD software, provides fully automated tuning of MALDI-TOF parameters within a sample run, delivering consistent data quality without user intervention. This seamless and effortless approach further increases performance, reproducibility, and up-time of the system.

2. Optimizing sample preparation for mycobacteria

As mycobacteria are challenging species in microbiology, an optimized sample preparation protocol is essential for robust results. The new MBT Mycobacteria IVD Kit offers a user-friendly, dedicated sample preparation method for mycobacteria cultivated in liquid as well as on solid media. The inactivation method for safe sample handling does not require boiling, but convenient incubation of the mycobacteria with an inactivation reagent at room temperature.

Dr. Arthur Pranada, Head of the Microbiology Division at MVZ Dr. Eberhard & Partner in Dortmund, stated: “During the last years the number of clinical samples with nontuberculous mycobacteria has increased, and reliable identification is important for an assessment of the clinical significance. The MBT Mycobacteria IVD Kit further simplifies the workflow for identification of nontuberculous mycobacteria by MALDI-TOF MS and reduces hands-on time. During the evaluation in our laboratory more than 96% of mycobacteria from solid and liquid media could be identified at a high-confidence level.”

Identifying challenging filamentous fungi

Identifying molds and multicellular fungi remains one of the most complex aspects of microbiology, because of varying culture conditions and colony morphology. The new MBT HT Filamentous Fungi IVD Module comes with an easy, yet powerful Mycelium Transfer (MyT) sample preparation procedure which together with a comprehensive reference library offers high identification success rates.

3. New LiquidArray® Gastrointestinal PCR Assay for Broad Syndromic Testing

Rapid culture-free pathogen identification: Bruker’s LiquidArray® technology offers rapid, multiplexed PCR pathogen detection for ease of implementation. Launched on the high-precision FluoroCycler® XT thermocycler, LiquidArray® combines innovative probe and thermocycling technologies with results-at-a-glance visualization for the simultaneous analysis of multiple targets from a single sample. The integrated FluoroSoftware® XT-IVD generates easy-to-interpret results, accelerating clinical decisions. The new LiquidArray® Gastrointestinal is a syndromic panel that enables the simultaneous detection of up to 26 pathogens causing gastroenteritis. LiquidArray® Gastrointestinal is validated on the GenoXtract® fleXT which streamlines extraction and PCR. This provides high-throughput clinical laboratories with a fully integrated workflow from sample to result.

Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “With the introduction of our new IVD workflows, kits, software and reference libraries for mycobacteria and fungi, we further expand the applications of our established MALDI Biotyper® platform. This creates additional value for all current and future customers. The new LiquidArray® Gastrointestinal is a next-generation syndromic panel with amazing pathogen coverage. It is ideal for laboratories which are interested in a broad screening approach to detect most pathogens in one run.”

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PRESS RELESE: Ad Astra Diagnostics Files FDA 510(k) Application for Rapid, Point-of-Care Analyzer to Detect Severe Infection, Including Sepsis

Ad Astra Diagnostics said Thursday it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the QScout RLD rapid-result hematology system to report white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six white blood cell types in fingerstick or venous blood.

The QScout hematology platform is a rapid testing system that would operate at the point of care to provide measurements indicative of disease and infection. Such measurements include a ratio of two white blood cell types (neutrophil-to-lymphocyte ratio) and count of immature granulocytes.

Whole blood is added to a QScout RLD (rapid leukocyte differential) test, which contains a dried reagent that stains cells. When the test is inserted in the QScout Lab analyzer, an optical system takes images and an algorithm identifies cells in real time. Results are displayed in about two minutes.

The technology was funded in part by a federal contract with the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA).

Specifically, the funding was awarded by the BARDA Division of Research, Innovation, and Ventures for the earlier detection of severe infection, including sepsis in prehospital settings.

Specific levels of immature infection-fighting granulocytes can be one of the earliest markers for sepsis, the body's extreme response to infection.

The firm is seeking clearance of the system “for use at point of care where faster results can improve health outcomes and in the lab where it can improve efficiency,” Joy Parr Drach, AAD's president and CEO, said in a statement. “Meanwhile, we will continue discussions with partners who can help reach those healthcare settings."

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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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