Amplified Sciences Earns CAP Lab Accreditation, Paving Way for PanCystPro Pancreatic Test Rollout

Pancreatic cancer is among the deadliest cancers partly because it is difficult to detect early. One particular challenge involves pancreatic cystic lesions - fluid-filled sacs found incidentally in millions of imaging scans each year. Most are benign, but distinguishing them from early malignancies currently requires either expensive surveillance, invasive procedures, or surgery that carries its own risks.

Amplified Sciences, a diagnostics company based in West Lafayette, Indiana and Irvine, California, is developing a blood-based test called PanCystPro designed to give physicians a more reliable way to rule out malignancy in these lesions. The company announced in late February 2026 that its clinical laboratory has received accreditation from the College of American Pathologists - a credential widely considered the most stringent laboratory standard in the United States.

What CAP Accreditation Requires and Why It Matters

The College of American Pathologists Laboratory Accreditation Program involves rigorous on-site inspection of clinical protocols, staff qualifications, equipment, safety programs, and overall laboratory management. The standard is designed to ensure that every aspect of sample handling and analysis meets the highest quality benchmarks, providing clinical partners - hospitals, health systems, and ordering physicians - with confidence in the reliability of test results.

The accreditation follows the company's federal CLIA certification in 2025, which granted legal authority to operate as a clinical laboratory. CAP accreditation goes further, providing independent validation from the professional pathology community.

"While our CLIA certification gave us the license to operate, CAP accreditation gives our clinical partners the license to trust," said CEO and co-founder Diana Caldwell. "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."

How PanCystPro Works

PanCystPro uses the company's proprietary BioMatra optical reporter platform, which combines multiomics analysis - integrating data from multiple biological measurement types - with computational algorithms to assess pancreatic cyst samples. The test reports a negative predictive value above 95% for ruling out malignancy, which Caldwell said allows many patients to safely avoid high-risk surgery while accurately identifying those who need monitoring or intervention.

Chief scientific officer V. Jo Davisson, who is also a professor of medicinal chemistry and molecular pharmacology at Purdue University's College of Pharmacy, said the CAP accreditation validates the clinical readiness of the company's protease turnover assays. Davisson disclosed the underlying intellectual property through Purdue's Office of Technology Commercialization, which executed an exclusive global license with Amplified Sciences.

Funding and Purdue Connection

Amplified Sciences is a portfolio company of Purdue Innovates Ventures, which most recently supported the company with an investment in its $2.6 million Series Seed Preferred capital raise in 2023. The company's deep ties to Purdue University's research infrastructure have shaped both its scientific platform and its commercialization pathway.

The early access program at UCSF represents the first clinical deployment of PanCystPro at a major academic medical center. How the test performs in that setting - and what data emerge on its real-world clinical utility - will be important inputs for any broader national rollout. The company has not yet published peer-reviewed clinical validation data from large prospective patient cohorts, and independent assessment of test performance will be an expected prerequisite for wider adoption.