Meridian Bioscience Receives FDA Clearance for New Group A Strep Molecular Test

Meridian Bioscience, Inc., has received FDA clearance for a new molecular diagnostic test for Group A Streptococcus on the illumigene^® platform.

Group A Streptococcus is a bacterium commonly found in the human throat or on skin and causes a wide variety of diseases in humans, the most common being acute pharyngitis or strep throat. Group A Streptococcus infections may result in mild illness (e.g. pharyngitis, impetigo) or may lead to invasive, life-threatening illness such as acute rheumatic fever, cellulitis, bacteremia, necrotizing fasciitis, or Streptococcal toxic shock syndrome.

illumigene Group A Strep represents a significant new advancement in healthcare by providing a molecular solution for the detection of Group A Strep pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States. Approximately 20-30% of children seeking physician care are diagnosed with Group A Strep pharyngitis. Traditional laboratory diagnosis is performed by rapid antigen testing or throat swab culture. Studies show that culture may miss up to 10% of true positives.

Accurate diagnosis of streptococcal pharyngitis followed by appropriate antibiotic therapy is important for the prevention and control of Group A Strep infections. The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes in throat samples. The test procedure is remarkably simple and highly sensitive. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour.

All reagents and disposables are contained in the test kit and can be stored at room temperature. The simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper patient management of this common and serious disease.
Donna Mayne, Supervisor of the Microbiology, Serology and Molecular Laboratories at Sacred Heart Hospital in Pensacola, Florida states, "The utilization of GAS molecular testing decreases our turnaround time and offers increased sensitivity."

Rick Eberly, Chief Commercial Officer stated, “illumigene Group A Strep is a significant addition to Meridian’s illumigene menu, especially as it offers the advantages of both faster and more accurate strep throat diagnostic results. This test continues the expansion of our illumigene technology, which allows healthcare professionals to implement a sophisticated molecular amplification test that is affordable, quick and easily administered in any lab or hospital setting.”

Furthermore, Jack Kraeutler, Chief Executive Officer, stated, “Meridian continues to focus on developing innovative technologies that help reduce the overall costs of healthcare. Our diagnostic tests are specifically developed for faster and more accurate detection and early diagnosis of acute infectious disease-causing pathogens. With illumigene Group A Strep, healthcare providers and patients can get a definitive strep throat diagnosis rapidly. As a result, they can help their patients reduce the risks of Group A Strep transmission and complications which ultimately contributes to decreasing healthcare costs.”