Amplified Sciences achieves CAP accreditation for cutting-edge diagnostic lab

Gold standard milestone clears the path for national expansion of PanCystPro™ assay

2026-02-27

(Press-News.org) 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.

About Amplified Sciences

Amplified Sciences is a life science diagnostics company focused on providing innovative tests that enable earlier detection, risk stratification and monitoring of serious diseases. Leveraging an ultra-sensitive optical reporter platform licensed from Purdue University, the company is headquartered in West Lafayette, Indiana, with its CAP-accredited and CLIA-certified clinical lab located in Irvine, California. To learn more, visit amplifiedsciences.com.

About Purdue Innovates Office of Technology Commercialization

The Purdue Innovates Office of Technology Commercialization operates one of the most comprehensive technology transfer programs among leading research universities in the U.S. Services provided by this office support the economic development initiatives of Purdue University and benefit the university’s academic activities through commercializing, licensing and protecting Purdue intellectual property. In fiscal year 2025, the office reported 161 deals executed with 269 technologies licensed, 479 invention disclosures received, and 267 U.S. and international patents received. The office is managed by the Purdue Research Foundation, a private, nonprofit foundation created to advance the mission of Purdue University. Contact otcip@prf.org for more information.

About Purdue University

Purdue University is a public research university leading with excellence at scale. Ranked among top 10 public universities in the United States, Purdue discovers, disseminates and deploys knowledge with a quality and at a scale second to none. More than 106,000 students study at Purdue across multiple campuses, locations and modalities, including more than 57,000 at our main campus locations in West Lafayette and Indianapolis. Committed to affordability and accessibility, Purdue’s main campus has frozen tuition 14 years in a row. See how Purdue never stops in the persistent pursuit of the next giant leap — including its integrated, comprehensive Indianapolis urban expansion; the Mitch Daniels School of Business; Purdue Computes; and the One Health initiative — at https://www.purdue.edu/president/strategic-initiatives.

Media contact: Diana Caldwell, diana.caldwell@amplifiedsci.com

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