Gold standard milestone clears the path for national expansion of PanCystPro™ assay
WEST LAFAYETTE, Ind. and IRVINE, Calif. — Amplified Sciences, a diagnostics life sciences company revolutionizing early disease detection, today announced that its clinical laboratory has been awarded accreditation by the College of American Pathologists (CAP).
CEO and co-founder Diana Caldwell said the gold standard recognition follows the company laboratory’s 2025 federal CLIA certification.
“It marks a critical milestone in the commercial scaling of PanCystPro™, our lead assay for pancreatic cancer risk stratification,” she said.
About the accreditation
Caldwell said the CAP Laboratory Accreditation Program is widely considered the most stringent in the world, designed to ensure the highest standard of care for all patients. To earn accreditation, Amplified Sciences’ lab underwent a rigorous on-site inspection of its clinical protocols, staff qualifications, equipment, safety programs and overall management.
“While our CLIA certification gave us the license to operate, CAP accreditation gives our clinical partners the license to trust,” she said. “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.”
“The CAP is pleased to recognize Amplified Sciences as meeting the high standard set as part of the CAP’s Laboratory Accreditation Program,” said Earle S. Collum, MD, FCAP, chair of the CAP’s Council on Accreditation. “Amplified Sciences joins the thousands of others that are committed to raising the quality of laboratory services nationally and internationally.”
Amplified Sciences’ precision diagnostics
Caldwell said the newly accredited laboratory performs the PanCystPro assay, which utilizes the company’s proprietary BioMatra™ optical reporter platform.
“By combining multiomics science with proprietary computation algorithms, PanCystPro helps clinicians accurately rule out malignancy in pancreatic cystic lesions with over 95% negative predictive value,” she said. “This precision allows many patients to avoid unnecessary, high-risk surgery while identifying those who need monitoring or intervention.”
V. Jo Davisson said CAP accreditation further validates the clinical readiness of the company’s unique protease turnover assays. He is the chief scientific officer at Amplified Sciences, a professor of medicinal chemistry and molecular pharmacology in Purdue University’s College of Pharmacy, and a member of the Purdue Institute for Cancer Research and the Purdue Institute for Drug Discovery.
“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,” he said.
He disclosed the intellectual property through the Purdue Innovates Office of Technology Commercialization. OTC executed an exclusive license with Amplified Sciences for the global suite of patents.
Amplified Sciences is a Purdue Innovates Ventures portfolio company. Ventures most recently supported Amplified Sciences with an investment in the company’s $2.6 million Series Seed Preferred capital raise in 2023.
