Amprion Clinical Laboratory Receives Accreditation From College Of American Pathologists
San Francisco, CA / Oct. 27th, 2021—Amprion announces that The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Amprion Clinical Laboratory, San Diego, California, based on recent on-site inspection results as part of the CAP’s Accreditation Programs.
The facility’s Director, Dr. Kendal J. Jensen, MD, was advised of this national recognition and congratulated for the excellence of the services being provided. Amprion Clinical Laboratory is one of more than 8,000 CAP-accredited facilities worldwide.
“The SYNTapTM Biomarker Test represents one of the newest classes of technology in the laboratory field. I am proud of our entire team, who worked tirelessly to achieve the first CAP-accredited protein amplification test for diagnostics application. We believe the SYNTap Test is a turning point in diagnosing neurodegenerative disorders such as Parkinson’s Disease (PD) and Lewy Body Dementia (LBD). Our breakthrough technology has demonstrated excellent performance in this area,” says Dr. Kendal Jensen, Amprion Clinical Lab Director.
Upon learning of the laboratory’s accreditation, Amprion CEO Dr. Russ Lebovitz, MD, echoed, “Congratulations to the Amprion team for passing the rigorous CAP inspection on the first go. The SYNTap Test has been validated with 87.3% sensitivity, 97.2% specificity, and overall accuracy of 93.9%—a testament to our team’s expertise, approach, and core technology. This momentous milestone propels us to the dawning of a new era—personalized medicine for neurodegenerative diseases. We are on a mission to end brain disorders.”
The U.S. federal government recognizes the CAP Laboratory Accreditation Program, which began in the early 1960s, as equal to or more stringent than the government’s inspection program.
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 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, read the CAP Annual Report at Cap.org.
A leader in prion detection science, Amprion innovates biomarker testing. The company offers its first commercial diagnostic application, SYNTapTM Biomarker Test, to aid physicians in the clinical diagnosis of Parkinson’s Disease (PD) and Lewy Body Dementia (LBD). This breakthrough test identifies misfolded Synuclein aggregates, a hallmark in various neurodegenerative diseases. The innovative assay can also be used to distinguish underlying synucleinopathy in patient evaluation for other neurological disorders, such as Alzheimer’s Disease (AD). Amprion plans to launch other biomarker tests, including misfolded Abeta and Tau, to detect Alzheimer’s in early stages.
View the CAP Certificate of Accreditation