AliveDx Takes Major Step for Celiac Disease Diagnostic Innovation
Innovative Diagnostics for Celiac Disease
AliveDx has made significant strides in the field of medical diagnostics with the submission of the 510(k) premarket notification for the MosaiQ AiPlex Celiac Disease (CD) microarray to the U.S. FDA. This milestone reflects the company's commitment to enhancing the accuracy and speed of celiac disease detection, making laboratory processes more efficient.
The MosaiQ AiPlex CD Microarray
The MosaiQ AiPlex CD is an advanced multiplex assay designed to provide comprehensive insights into celiac disease within a streamlined workflow. This innovation allows healthcare providers to utilize a single test to quickly determine the presence of various biomarkers associated with celiac disease, effectively reducing the time it takes to arrive at a diagnosis.
Benefits of the New Assay
This new assay has been engineered to not only improve the speed of diagnosis but also maintain high accuracy, integrating both IgA and IgG isotypes into one test. With just 20 ?l of patient sample, clinicians can access substantial data — a crucial feature given that celiac disease can often manifest with delayed diagnoses due to its varied symptoms.
By including five markers per patient panel based on the latest clinical guidelines, the MosaiQ AiPlex CD microarray stands out as a comprehensive diagnostic tool. The ability to rapidly identify up to 425 disease markers per hour means that clinical labs will be equipped to handle high volumes of testing efficiently, which can lead to better patient outcomes.
Understanding Celiac Disease
Celiac disease is a complicated autoimmune disorder that affects approximately 1 in 100 individuals worldwide. Triggered by gluten in genetically predisposed people, the disease leads to significant intestinal damage and the production of autoantibodies. The innovative MosaiQ AiPlex CD microarray helps healthcare providers better understand and manage this condition through accurate serological evaluations.
Statements from Leadership
Manuel O. Méndez, CEO of AliveDx, expressed the company’s enthusiasm regarding this milestone submission. "The average diagnostic journey for autoimmune diseases often spans several years. The MosaiQ AiPlex CD solution is designed to shorten that timeline, facilitating quicker diagnoses and more targeted treatments — improvements that are critically needed in patient care today," he stated.
Streamlined Laboratory Workflows
The MosaiQ solution enhances laboratory efficiency through its user-friendly design. By consolidating multiple relevant markers into one test, not only does it facilitate faster decision-making, but it also minimizes extensive manual labor and consumable materials, promoting a more sustainable lab environment. This comprehensive system supports both internal and external quality controls to maintain high standards of performance.
About AliveDx
AliveDx has been a leader in in-vitro diagnostics for over 30 years, striving to improve the landscape of diagnostic testing. With dedicated efforts focused on autoimmune diseases and allergies, AliveDx aims to empower laboratories and healthcare providers alike with innovative solutions that enhance patient care. Their portfolio, which includes the renowned MosaiQ and LumiQ brands, is created with a vision towards generating economic and clinical value through simpler workflows and rapid, precise results.
Further Innovations with the MosaiQ Solution
The MosaiQ solution represents a cutting-edge advancement in IVD for a wide array of conditions. The automated planar microarray platform is tailored for high throughput syndromic testing, addressing the demand for rapid and accurate laboratory results in today’s healthcare landscape. This approach not only meets the needs of clinicians but also addresses the evolving expectations for laboratory efficiency.
Frequently Asked Questions
What is the MosaiQ AiPlex CD microarray?
The MosaiQ AiPlex CD microarray is a multiplex assay designed for the diagnosis of celiac disease, improving accuracy and efficiency in testing.
What are the advantages of using this assay?
This assay offers a faster diagnosis with a single test for multiple biomarkers, simplifying the laboratory workflow and improving patient care.
How does celiac disease affect patients?
Celiac disease is an autoimmune condition triggered by gluten, leading to various symptoms and significant intestinal damage.
What impact does AliveDx aim to have on diagnostics?
AliveDx seeks to innovate and improve diagnostic processes, enhancing patient experiences by providing accurate and timely results.
How can I learn more about AliveDx?
To learn more about AliveDx and their innovative diagnostics solutions, please visit their official website.
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