DevLab Bio Awarded CAP Accreditation

Expanding CLIA-certified Contract Research and Clinical Diagnostics Laboratory Secures CAP Approval

DevLab bio

DevLab, LLC is proud to announce that the College of American Pathologists (CAP) has awarded accreditation to DevLab, LLC, dba DevLab bio, by the Accreditation Committee due to results of an on-site inspection performed by the CAP Accreditation Program. The DevLab bio clinical laboratory provides diagnostic testing and supports its Contract Research Services division.

"Quality is key to ensuring a laboratory's performance, accuracy of test results, and overall patient care," says Aaron LeFebvre, Ph.D., DevLab bio's VP of Research and Development and Laboratory Director. "Having now received our CAP accreditation, DevLab bio can assure physicians and patients that our laboratory meets some of the highest standards of quality worldwide. The entire team at DevLab puts quality and patient care first. They know there is a person attached to every test result, and we make it our business to take care of those we serve."

Recognized by the U.S. federal government as being equal to or more stringent than their own inspection program, the CAP Laboratory Accreditation Program began in the early 1960s. During the CAP-accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.

About DevLab bio

DevLab bio is a CAP/CLIA-accredited Clinical Diagnostics laboratory and Contract Research Service company founded in 2018 in Cleveland, Ohio, and was originally located on Case Western Reserve University campus. In 2020, DevLab relocated to Carrollton, Texas, a suburb of Dallas, Texas, which is where the Contract Research Service division is located. The Clinical Diagnostics laboratory is in Coppell, Texas.

Our Contract Research Services team provides a full suite of resources from laboratory services and test development to support for product development projects. We can initiate projects quickly, reduce risks and avoid unnecessary costs. The Clinical Diagnostics team coordinates with specific clinical projects that require and benefit from both a research laboratory and a CAP/CLIA facility.

Our Clinical Diagnostics team not only supports Contract Research Services, it has risen to the occasion throughout the pandemic to support our local communities by providing COVID-19 testing (RT-PCR, antibody testing and our patent-pending neutralizing antibody test). Our dedicated team has provided testing throughout the pandemic and will continue to support our local physicians and patients with a quick-turnaround test option. Additionally, we provide an extensive menu of allergen (food, respiratory and indoor) and autoimmune diagnostic tests. 

DevLab bio delivers the necessary resources to design novel assays, develop and confirm benchmarks, support commercializing concepts via proof of concept, new products development and providing a route to LTD/EUA/FDA approval. Our comprehensive services include molecular diagnostics, immunoassay, antibody generation and a range of development services. We provide IP support and operate with regulatory expertise in CAP/CLIA, GLP/GMP and ISO compliance. 

Our commercialization support includes evaluating technologies, scientific and product expertise support, project management and laboratory facilities for building and testing products. DevLab bio provides business infrastructure and marketing guidance. 

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, please visit www.cap.org.

For more information, contact Lisa Sutton - lsutton@devlabbio.com or visit www.devlabbio.com.

Source: DevLab, LLC