Image created by Dr. Michael J. Miller
Diasorin has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS) assay for use on the LIAISON NES Point-of-Care (POC) molecular diagnostics platform.
The new LIAISON NES Group A Strep test is designed to deliver rapid, definitive molecular results for Group A Streptococcus at the point of care in approximately 15 minutes, helping healthcare providers in outpatient and decentralized settings accurately diagnose acute pharyngitis and support appropriate patient management.
Expansion of the LIAISON NES molecular diagnostics menu
The FDA 510(k) clearance and CLIA waiver for the LIAISON NES Group A Streptococcus assay follows the FDA clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay in December 2025. With this latest authorization, Diasorin further expands the clinical utility and test menu of the LIAISON NES platform, supporting near-patient molecular testing for high-impact respiratory and throat infections.
Group A Streptococcus is a leading bacterial cause of acute pharyngitis and accounts for millions of healthcare visits each year. Because symptoms of bacterial and viral infections often overlap, accurate and timely identification of Group A Streptococcus is essential to guide treatment decisions, reduce unnecessary antibiotic use, and improve patient outcomes.
Addressing limitations of traditional Group A Strep testing
Traditional diagnostic methods for Group A Streptococcus may require centralized laboratory testing or rely on less sensitive rapid antigen tests. These approaches can delay treatment decisions, increase the need for confirmatory culture, and complicate patient management.
The LIAISON NES platform is designed to address these challenges by combining molecular-level accuracy with the speed and simplicity required in decentralized and outpatient environments. By enabling reliable results during the initial patient visit, the system supports more efficient clinical workflows and helps reduce the need for follow-up appointments.
Key features and benefits of the LIAISON NES Group A Strep test
The LIAISON NES Group A Streptococcus assay offers several advantages for clinicians and healthcare organizations seeking rapid, accurate point-of-care testing:
- Rapid results: Provides actionable results as soon as a positive target is amplified, with definitive negative results in approximately 15 minutes, enabling earlier clinical decisions without requiring confirmatory culture.
- High sensitivity and specificity: Delivers molecular-level accuracy using PCR technology, ensuring reliable detection of Group A Streptococcus at the point of care.
- Simple workflow: Utilizes the same easy workflow as the previously cleared LIAISON NES FLU A/B, RSV & COVID-19 assay, with under one-minute hands-on time and room temperature reagents to optimize ease of use.
- Point-of-care ready: Features a compact, cloud-connected system that supports real-time reporting and is well suited for outpatient clinics and other decentralized settings.
By enabling accurate diagnosis in a single visit, the LIAISON NES Group A Strep test supports timely clinical decision-making, reduces the need for follow-up visits, and helps minimize inappropriate antibiotic prescribing.
“The addition of Group A Strep reflects our commitment to expanding the LIAISON NES menu to address high-impact infectious diseases,” said Angelo Rago, President of Luminex Corporation. “We continue to build a robust pipeline that enhances the clinical value of near-patient molecular testing while reinforcing our leadership in diagnostics.”
Frequently asked questions
What FDA clearances did the Diasorin LIAISON NES Group A Streptococcus assay receive for point-of-care molecular diagnostics?
The Diasorin LIAISON NES Group A Streptococcus (GAS) assay received both 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA). These authorizations enable use of the molecular diagnostics test on the LIAISON NES point-of-care platform, supporting rapid, near-patient detection of Group A Streptococcus in outpatient and decentralized healthcare settings.
How does the LIAISON NES Group A Strep test improve diagnosis of acute pharyngitis compared with traditional Group A Streptococcus testing?
The LIAISON NES Group A Strep test delivers molecular-level PCR accuracy with definitive negative results in about 15 minutes at the point of care. Unlike traditional centralized lab methods or less sensitive rapid antigen tests, it provides reliable results during the initial visit, reducing the need for confirmatory culture, follow-up appointments, and unnecessary antibiotic prescribing for acute pharyngitis.
How does the LIAISON NES platform expand near-patient molecular testing for respiratory and throat infections?
The LIAISON NES platform now includes the Group A Streptococcus assay and the previously cleared FLU A/B, RSV & COVID-19 assay (cleared in December 2025). This expanded test menu supports near-patient molecular testing for high-impact respiratory and throat infections, offering a compact, cloud-connected, point-of-care system with simple workflow, room temperature reagents, and under one-minute hands-on time.