#United States #Birmingham #Molecular Designs #Simplicity DX #Respiratory Panel

Molecular Designs Submits Simplicity™DX Respiratory Panel for FDA Approval

On October 2, 2025, Molecular Designs, a pioneer in developing and manufacturing molecular infectious disease assays, announced the submission of a 510(k) premarket notification for its Simplicity™DX Respiratory Panel to the U.S. Food and Drug Administration (FDA). Designed for the concurrent detection of critical respiratory viruses, this in vitro diagnostic (IVD) panel can simultaneously identify SARS-CoV-2 (the virus responsible for COVID-19), Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV). 

The Significance of This Submission

The submission of this IVD product to the FDA represents a major development for Molecular Designs. CEO Michael Clark emphasized the importance of this milestone, stating, "This reflects our commitment to providing laboratories with tools that are not only clinically effective but also practical and efficient for everyday use. Our goal is to facilitate streamlined testing workflows without compromising accuracy or flexibility."

The Simplicity™DX Respiratory Panel employs a multiplex real-time RT-PCR assay tailored to detect viral RNA from anterior nasal swabs. It comprises two specific targets for SARS-CoV-2, one each for the Influenza A and B strains, alongside two targets for RSV, all while integrating an internal control to ensure the validity of the test runs.

Innovative Design for Efficiency and Flexibility

One of the standout features of this panel is its breakaway format. This innovation allows laboratories to utilize only the necessary tests during specific runs, resulting in minimized waste and optimized inventory management. By lowering costs through this flexible design, labs can better respond to staffing limitations or variable testing demands that often challenge laboratory operations.

As many laboratories transition towards multiplex panels to enhance respiratory testing, the Simplicity™DX Respiratory Panel emerges as a practical solution, offering a single, efficient workflow for various assays. This format not only supports batch processing but also reduces the need for repeated control runs, thereby enabling labs to manage larger volumes of tests without incurring additional workload.

A Focus on Clinical Needs

Developed by a team of physicians specializing in diagnostics, the Simplicity™DX Respiratory Panel is crafted to meet the daily operational needs of clinical laboratories. The company's agility in crafting solutions tailored to evolving testing needs highlights its dedication to healthcare providers. Molecular Designs emphasizes that it’s fully equipped to support labs through validation processes, onboarding, and overall implementation efforts.

About Molecular Designs

Founded by a group of physicians on a mission to simplify the delivery of molecular diagnostic technologies, Molecular Designs aims to boost accessibility and cost-effectiveness in healthcare solutions. The company manufactures a variety of PCR-based components following stringent GMP and ISO 13485:2016 quality standards, further supporting labs with complementary reagents and necessary instrumentation for testing. More information can be found on their website at moleculardesigns.com or follow them on LinkedIn for updates.

Conclusion

In summary, the submission of the Simplicity™DX Respiratory Panel represents a significant step forward in the realm of infectious disease diagnostics, enabling improved respiratory virus detection at a time when such capabilities are critically needed in clinical settings across the globe.