Performance Testings

Global Lab Resources

Ensuring the optimal performance of medical devices involves meticulous evaluation within Clinical Laboratory Improvement Amendments (CLIA) and ISO 15189 accredited labs. We specialize in designing and executing evaluations , ensuring precise and reliable assessments of medical device functionality and efficacy.

Extensive Laboratory Partnerships

Collaborating with 200+ state-of-the-art laboratories specialized in In Vitro Diagnostic (IVD) product development and performance studies, we stand as pioneers in technological innovation within this domain. Our strategic partnerships specifically focus on leveraging these cutting-edge facilities to advance IVD technologies. By combining our expertise with these specialized labs, we conduct meticulous performance studies dedicated to refining and validating IVD products. This collaboration ensures that our efforts are squarely focused on pushing the boundaries of innovation, accuracy, and reliability in diagnostic solutions, driving the evolution of next-generation IVD technologies.

Pioneering Technological Advancements

Our R&D team comprises top talent from leading institutions in the US and EU, specializing in molecular biology and IVD product development. This global collaboration unites diverse expertise, fostering innovation and advanced technological knowledge exchange. Leveraging insights from across continents, we pioneer cutting-edge solutions, ensuring our products exceed industry standards. This multidimensional approach enables us to continuously drive advancements, delivering precise and groundbreaking contributions to molecular biology and the IVD sector.

Reinforced Quality Assurance

Our IVD sector boasts a robust structure, comprising multiple layers of expertise including dedicated Project Managers, PhD professionals, and skilled Lab Technicians. This layered approach ensures a meticulous focus on testing, reporting, and protocol drafting, guaranteeing adherence to stringent compliance standards while safeguarding the integrity of results. With this specialized team overseeing operations, we maintain a steadfast commitment to precision and reliability in our processes, bolstering confidence in the accuracy and trustworthiness of our findings.

TAILORED TESTING SERVICES

Our laboratory holds certifications: CLIA/CAP, including EU state certification and ISO 13485 compliance. These additional certifications further demonstrate your commitment to meeting rigorous international quality standards and regulatory requirements in your specialized fields of Allergy & Immunology, Diagnostic Genetics, Molecular Microbiology, and Chemistry/Toxicology testing.

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Molecular Microbiology

Through PCR-based diagnostics, we provide comprehensive screening and identification for various pathogens affecting the respiratory, urinary, and reproductive systems, demonstrating a commitment to addressing a wide range of infectious conditions with precision and efficiency.

Genetics Testing

we specialize in conducting a range of advanced genetic testing methodologies. This includes pinpointing individual genes, conducting thorough analyses using both small and large gene panels, performing whole exome sequencing, and employing cutting-edge digital PCR techniques.

Toxicology

We excel in drug screening and confirmation utilizing mass spectrometry techniques. This methodology ensures highly accurate and reliable results in identifying and confirming the presence of substances, showcasing our commitment to providing thorough and precise toxicology testing.

Flow Cytometry

We provide specialized testing services for lymphophenotyping (SIP) and basophil activation testing (BAT) tailored for allergen analysis. These precise methodologies underscore our commitment to delivering comprehensive and accurate immunological assessments.

Angioedema Complement and Bradykinin Assays

We offer specialized testing services for Angioedema Complement and Bradykinin Assays, focusing on the assessment of C1 esterase inhibitor function and Bradykinin levels. These tests are tailored to provide detailed insights into angioedema conditions, specifically evaluating the complement system and bradykinin pathways.

Allergy

We specialize in conducting Allergen and Component-Specific IgE and IgG4 ImmunoCAP™ testing, along with allergy flow cytometry (BAT). These services are tailored to provide comprehensive insights into allergic reactions by assessing specific immunoglobulin responses to allergens and components. Our commitment to these testing methods underscores our dedication to delivering precise and comprehensive allergy diagnostics.