Tuesday, September 19, 2023

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.

Friday, August 25, 2023

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."  

Thursday, August 24, 2023

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.

Friday, August 11, 2023

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.

Monday, July 17, 2023

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. 

Saturday, July 15, 2023

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. 

Saturday, June 17, 2023

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.