Key Takeaways
- AliveDx has received IVDR-CE mark certification for its MosaiQ AiPlex™ CD microarray immunoassay, providing a more accurate and faster diagnostic tool for celiac disease across CE-mark accepting regions.
- The MosaiQ AiPlex™ CD assay simplifies the diagnostic process by detecting key biomarkers from a single blood sample, reducing delays in celiac disease diagnosis and enabling quicker patient treatment with a GFD.
- AliveDx’s new assay represents a significant advancement in diagnostic technology, streamlining laboratory workflows, minimizing errors, and delivering consistent results to healthcare providers while expanding the company’s impact globally.
AliveDx, a leader in diagnostic innovation, is proud to announce that it has received IVDR-CE mark certification for its groundbreaking MosaiQ AiPlex™ celiac disease (CD) microarray immunoassay. This advanced assay, designed to enhance the speed and accuracy of diagnosing celiac disease, is now certified under the stringent In Vitro Diagnostic Regulation (IVDR) standards of the European Union. The IVDR-CE mark ensures the assay is safe, effective, and ready for widespread clinical use in geographies that accept CE-mark certification, enabling AliveDx to expand its impact in improving the lives of those affected by celiac disease.
The MosaiQ AiPlex™ CD microarray immunoassay marks a significant step forward in celiac disease diagnostics. Celiac disease, an autoimmune disorder triggered by the ingestion of gluten, is often difficult to diagnose, leading to delays in treatment and potentially severe long-term health consequences if left untreated. The AliveDx solution is designed to tackle this challenge head-on by offering healthcare providers a novel, efficient tool that shortens the diagnostic pathway and enhances the accuracy of testing.
Unlike traditional testing methods, which often require multiple tests over an extended period, the MosaiQ AiPlex™ CD microarray immunoassay incorporates the most clinically relevant autoantibodies related to celiac disease: tTG IgA, DGP IgA, tTG IgG, and DGP IgG, as well as total IgA antibodies. This comprehensive approach allows the assay to provide more complete diagnostic insights from a single blood sample, reducing the need for repeated tests and unnecessary delays in diagnosis. By streamlining the diagnostic process, AliveDx aims to alleviate the burden of testing on both patients and healthcare providers.
MosaiQ AiPlex™ Celiac Disease Assay Streamlines Celiac Disease Diagnosis, Reducing Delays and Enhancing Patient Care
The newly IVDR-CE marked MosaiQ AiPlex™ CD assay offers healthcare professionals a unique solution that simplifies laboratory workflows and delivers faster results. With the ability to detect key biomarkers of celiac disease, the assay helps automate the diagnostic process, enabling laboratories to increase efficiency and reduce turnaround times. This is particularly critical in reducing the diagnostic delay that often plagues celiac disease patients, who can suffer for years before receiving a definitive diagnosis. By improving the speed and accuracy of diagnosis, patients can quickly begin appropriate treatments, such as adopting a Gluten-Free Diet (GFD), to alleviate gastrointestinal symptoms and prevent long-term health complications such as malnutrition, osteoporosis, and increased risk of certain cancers.
Moreover, the streamlined nature of the MosaiQ AiPlex™ CD immunoassay allows healthcare providers to obtain comprehensive diagnostic insights with a single blood draw, making it less invasive and more convenient for patients. This single-sample method not only reduces patient discomfort but also accelerates the diagnostic journey, ensuring that individuals with celiac disease can begin managing their condition as soon as possible.
Celiac disease affects millions of people globally, and early, accurate diagnosis is key to improving patient outcomes. AliveDx’s new multiplexed assay represents a major leap in diagnostic technology, delivering both clinical and operational benefits to healthcare systems. By automating the detection of celiac disease-specific antibodies, the MosaiQ AiPlex™ CD assay reduces manual steps in the laboratory, minimizes errors, and allows for more consistent and reliable results.
AliveDx Secures IVDR-CE Mark, Expanding Reach of Innovative Celiac Disease Diagnostic Solutions Across Europe
The IVDR-CE mark certification is a testament to AliveDx’s commitment to meeting the highest regulatory standards, ensuring that its products are safe, reliable, and effective for clinical use. This certification also enables AliveDx to extend its reach across Europe and other regions that recognize CE-mark certification, bringing this innovative diagnostic solution to a broader patient population.
In addition to receiving the IVDR-CE mark, AliveDx continues to focus on developing and deploying advanced diagnostic technologies that transform patient care. The company’s mission is to empower healthcare professionals with actionable insights that lead to better clinical decision-making and improved patient outcomes. By leveraging its aiOS™ platform and innovative diagnostic tools like the MosaiQ AiPlex™ CD immunoassay, AliveDx is positioning itself at the forefront of diagnostic innovation.
“Our mission at AliveDx is to empower diagnostic insights, transform patient care, and innovate for life,” said a representative of AliveDx. “With the IVDR-CE mark certification of our MosaiQ AiPlex™ CD microarray immunoassay, we are now able to offer healthcare providers a powerful tool to enhance the diagnosis of celiac disease. This marks a significant milestone in our commitment to advancing diagnostic technology and improving the lives of those affected by this condition.”
AliveDx Expands Global Reach with CE-Marked Celiac Disease Assay, Enhancing Diagnostic Efficiency and Patient Care
As AliveDx expands its impact across geographies that accept CE-mark certification, the company remains dedicated to supporting healthcare providers in delivering faster, more accurate diagnoses for celiac disease. This new assay represents a critical step in addressing the growing demand for more efficient, reliable diagnostics, especially in regions where healthcare resources are stretched.
By continuing to innovate and develop diagnostic tools that streamline workflows and provide actionable insights, AliveDx is helping to reduce the burden of celiac disease testing on both patients and laboratories. With the MosaiQ AiPlex™ CD immunoassay now certified for clinical use in Europe and beyond, AliveDx is poised to make a lasting impact on the healthcare landscape, improving patient care and outcomes on a global scale.
In summary, the IVDR-CE mark certification for the MosaiQ AiPlex™ CD microarray immunoassay underscores AliveDx’s ongoing commitment to innovation, safety, and effectiveness in diagnostics, ensuring that healthcare providers are equipped with the tools they need to transform patient care for those affected by celiac disease.
Resource: AliveDx, September 03, 2024
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