The accreditation enables commercial scaling of the company’s PanCystPro assay for pancreatic cancer risk assessment.
Amplified Sciences announced that its clinical laboratory has received accreditation from the College of American Pathologists (CAP), marking a milestone for the commercial expansion of its PanCystPro assay for pancreatic cancer risk stratification.
The CAP accreditation follows the company’s 2025 Clinical Laboratory Improvement Amendments (CLIA) certification and enables broader deployment of the diagnostic test to healthcare systems.
“While our CLIA certification gave us the license to operate, CAP accreditation gives our clinical partners the license to trust,” says Diana Caldwell, chief executive officer and co-founder of Amplified Sciences, in a release. “Achieving this benchmark is not just a regulatory check mark; it is a testament to our team’s commitment to quality as we roll out PanCystPro to leading health care systems, starting with our early access program at the University of California, San Francisco.”
Laboratory Inspection Process
To earn CAP accreditation, Amplified Sciences’ laboratory underwent an on-site inspection of its clinical protocols, staff qualifications, equipment, safety programs and overall management. The CAP Laboratory Accreditation Program is designed to ensure high standards of patient care through stringent requirements.
“The CAP is pleased to recognize Amplified Sciences as meeting the high standard set as part of the CAP’s Laboratory Accreditation Program,” says Earle S Collum, MD, FCAP, chair of the CAP’s Council on Accreditation, in a release. “Amplified Sciences joins the thousands of others that are committed to raising the quality of laboratory services nationally and internationally.”
PanCystPro Assay Technology
The newly accredited laboratory performs the PanCystPro assay, which utilizes the company’s proprietary BioMatra optical reporter platform. The test combines multiomics science with computation algorithms to help clinicians rule out malignancy in pancreatic cystic lesions with over 95% negative predictive value, according to the company.
“This precision allows many patients to avoid unnecessary, high-risk surgery while identifying those who need monitoring or intervention,” says Caldwell in a release.
V Jo Davisson, chief scientific officer at Amplified Sciences and professor of medicinal chemistry and molecular pharmacology in Purdue University’s College of Pharmacy, says the CAP accreditation validates the clinical readiness of the company’s protease turnover assays.
“By maintaining these elite standards, we ensure that every microliter of patient sample analyzed in our lab provides the reliable, biological insight necessary to address one of the world’s deadliest cancers,” says Davisson in a release.
The intellectual property for the technology was licensed from Purdue University through the Purdue Innovates Office of Technology Commercialization. Amplified Sciences is headquartered in West Lafayette, Indiana, with its CAP-accredited and CLIA-certified clinical laboratory located in Irvine, California.
Photo caption: Purdue University researcher V. Jo Davisson and CEO Diana Caldwell are the founders of Amplified Sciences, a clinical-stage life sciences diagnostic company that focuses on accurately detecting and categorically assessing the risks of debilitating diseases. The company’s clinical laboratory has been awarded accreditation by the College of American Pathologists.
Photo credit: Purdue Research Foundation photo/Vincent Walter
