IDM-Testing
IDM (Infectious Disease Marker) testing is a critical component of stem cell donor diagnostics as well as a crucial step in cell therapeutic products ensuring the safety of both the donor and the recipient.
1. Ensuring Patient Safety and Quality Control
Both stem cell therapies and ATMPs involve the use of living biological materials, such as cells or gene-modified tissues, which are critical to the treatment's success. At Lab Quade, our expert testing ensures that these products are free from infectious agents, significantly reducing the risk of complications for patients, especially those who are immunocompromised. By rigorously screening for infectious diseases, we ensure the therapeutic product is safe, effective, and prepared for clinical use.
2. Safeguarding Against Cross-Contamination and Infection
Whether it’s allogeneic stem cells sourced from donors or autologous cells derived from the patient themselves, the risk of contamination during harvesting, processing, and administration is a significant concern. Our comprehensive Infectious Disease Marker (IDM) testing covers a wide spectrum of potential pathogens, including HIV, hepatitis B and C, HTLV, and others. This advanced testing ensures that cell-based therapies or gene-modified products remain uncontaminated, offering optimal safety and efficacy.
3. Regulatory Compliance and Industry Standards
The development and application of ATMPs and stem cell-based treatments are highly regulated by authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Our extensive experience in this field also includes compliance with Good Manufacturing Practice (GMP) standards.
4. Protecting Vulnerable Patient Populations
Patients receiving ATMPs or stem cell transplants are often dealing with severe underlying conditions or undergoing immunosuppressive treatments. As a result, they are at a higher risk of infections. IDM testing identifies any potential risks before they arise, ensuring that patients are protected and giving healthcare providers confidence in the safety of the therapies they administer.
5. Supporting Global Donor Networks and Tissue Safety
In the case of allogeneic stem cell or ATMP therapies that involve materials from a global donor pool, it is essential to maintain the highest standards of donor safety. Our expertise ensures that every step—from donor screening to final product release—is supported by comprehensive IDM testing to avoid cross-border transmission of infectious diseases. This global approach enhances the safety and reliability of the donor network, enabling wider access to life-saving therapies.
Our experience
With years of experience in stem cell diagnostics and ATMP support, Lab Quade is a trusted partner for medical professionals and researchers in this rapidly advancing field. We leverage the latest in testing technology and methodologies, including advanced PCR-based diagnostics, high-sensitivity immunoassays, to provide the most accurate and reliable results.
Our commitment to excellence has positioned us as a leader in the diagnostics of these transformative therapies, and we continue to innovate and evolve alongside the evolving landscape of regenerative medicine.
