Monday, March 06, 2023

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.

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.