AliveDx Receives FDA Approval for MosaiQ Multiplex Testing Device Targeting Autoimmune Diseases and Allergies
AliveDx's MosaiQ®: A Game-Changer in Diagnostics
AliveDx, a global leader in in-vitro diagnostics, has achieved a significant milestone with the FDA's approval of its MosaiQ® device as a Class II medical product. This groundbreaking technology is poised to transform patient care by automating multiplex tests for autoimmune diseases and allergies, enhancing laboratory efficiency and diagnostic accuracy.
The MosaiQ Technology
The MosaiQ device utilizes a state-of-the-art random-access immunoassay platform designed to deliver rapid and multiplex results. This innovative solution enables laboratories to perform complex tests more efficiently, ultimately resulting in better patient outcomes. By tapping into the potential of this next-generation technology, clinicians can expect elevated insights from their diagnostic processes.
Key Features of MosaiQ
- - Automated Workflows: The fully automated testing process includes built-in quality control and calibration features, reducing overhead costs while enhancing operational efficiency.
- - Rapid Results: MosaiQ enables multiple tests from a single serum sample, with the initial result returned in less than one hour and subsequent results every 42 seconds, streamlining the patient testing experience.
- - Valuable Insights: With multiplex panels, MosaiQ supports syndrome-based testing, enabling the identification of comorbid conditions and providing physicians with comprehensive insights for more informed decision-making.
Regulatory Approval and Market Launch
The FDA's Class II (510(k)) approval marks a pivotal point for AliveDx, allowing the MosaiQ device to be utilized in clinical laboratories across the United States. This has paved the way for broader access to a high-throughput automated testing platform, making vital diagnostic tools more available to medical professionals and their patients.
AliveDx CEO Manuel O. Méndez expressed excitement about this development, emphasizing the company's commitment to collaborating with laboratories and clinicians to derive diagnostic insights that enhance patient care outcomes. The approval aligns with AliveDx's mission to innovate diagnostics for improved healthcare delivery.
Testing Capabilities of MosaiQ
The MosaiQ system offers an extensive menu of multiplex assays specifically tailored for autoimmune diseases and allergies. Developed in accordance with recommended clinical guidelines, these assays include:
- - AiPlex ®CTDplus: A 15-marker comprehensive panel designed for connective tissue diseases like RA and SLE.
- - AiPlex ®CD: A celiac disease panel featuring five markers that include IgA and IgG on a microarray.
- - AiPlex ®VAS: A three-marker vasculitis panel for essential autoantibody markers like MPO, PR3, and GBM.
- - AiPlex ®APS: A four-marker antiphospholipid syndrome panel that combines IgM and IgG markers, enhancing diagnostic precision in complex cases.
- - AllergyPlex ®COMBO: This panel includes up to 34 relevant allergen markers, providing comprehensive testing options for allergy assessments.
Additional panels are in development, aimed at addressing organ-specific autoimmune disorders and more targeted allergy components, reflecting AliveDx's commitment to innovation in diagnostic testing.
Future Directions for AliveDx
With the FDA approval secured, AliveDx is now focusing on preparing applications to seek 510(k) clearance for the assays available on the MosaiQ system. As the demand for high-quality diagnostic solutions grows, AliveDx aims to remain at the forefront of advancements in the field.
About AliveDx
With over three decades of experience in in-vitro diagnostics, AliveDx is dedicated to advancing patient care through innovative solutions. Their range of products, including the MosaiQ and LumIQ brands, is designed to simplify laboratory workflows while delivering fast and accurate results to enhance clinical decision-making. By fostering a positive and sustainable working environment for healthcare providers, AliveDx continues to push the boundaries of what is possible in diagnostic innovation.
For further details about AliveDx and its offerings, visit www.alivedx.com and follow them on LinkedIn and other platforms.
Topics Health）
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