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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