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Devyser Genomic Laboratories receives Accreditation from College of American Pathologists

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News | March 24, 2025

The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Devyser Genomic Laboratories, Roswell, Georgia, based on the results of a recent on-site inspection as part of the CAP’s Accreditation programs. Recognized for rigorous and robust standards, CAP accreditation elevates quality and mitigates risk, an important way that laboratories can contribute to improved patient outcomes.

The facility’s director, Daniel H. Farkas PhD, HCLD, was advised of this global recognition and congratulated on the excellence of the services provided. Devyser Genomic Laboratories is one of more than 8,000 CAP-accredited facilities worldwide. 

“Achieving CAP accreditation is a huge achievement for our US based lab and a testament to the high standards we uphold in genetic testing. The accreditation is as per our expected timeline and enables us to accelerate the upcoming reimbursement and launch activities of our post-transplantation test for solid organs, TransplantTrace cfDNA” says Devyser’s Chief Commercial Officer, Theis Kipling. 

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. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management. These reviews help verify activities and reflect the most recent best practices. 

With over 23,000 laboratory participants, in addition to accreditation, the CAP offers proficiency testing/external quality assessment (PT/EQA) programs, quality improvement tools, and protocols and guidelines to ensure excellence in all areas across the laboratory. Built on a foundation of pathologist expertise, the College of American Pathologists (CAP) partners with laboratories worldwide to elevate the quality of laboratory medicine with best-in-class solutions designed to drive operational excellence, achieve diagnostic confidence, and ensure the best patient care. 

For more information, please contact:
Fredrik Dahl, interim CEO 
E-mail: ir@devyser.com
Telephone: +46 8 562 158 50
 
Theis Kipling, CCO
E-mail: ir@devyser.com 
Telephone: +46 8 562 158 50

About Devyser
Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 65 countries. Our products are used for advanced genetic testing in the hereditary disease, oncology and transplant fields, to enable targeted cancer treatment, the diagnosis of a large number of genetic diseases, and transplant patient follow-up. Devyser's products, and unique, patented solution requiring only one test tube, simplify genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. Our goal is for every patient to receive a correct diagnosis in the shortest possible time. Sustainability is a central part of our business and an important prerequisite for long term value creation.

Devyser was founded in 2004 and is based in Stockholm, Sweden with eight in-house sales offices in Europe and the US. The company also runs Devyser Genomic Laboratories, a CLIA certified laboratory in Atlanta, US. In 2022, Devyser's quality management system was certified according to the IVDR and a number of the company's products have since been certified according to the IVDR.

Devyser's shares are listed on the Nasdaq First North Premier Growth Market Stockholm (ticker: DVYSR). The company's Certified Adviser is Redeye AB. 

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, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.

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