image: Amplified Sciences — led by CEO Diana Caldwell (right) and Chief Scientific Officer V. Jo Davisson — has received regulatory clearance under the federal Clinical Laboratory Improvement Amendments program to test PanCystPro, which risk stratifies patients with pancreatic cystic lesions, a precursor for pancreatic cancer. The company was featured in the Indiana Economic Development Corp.’s 2024 edition of Entrepreneurship Indiana.
Credit: (Photo provided/Indiana Economic Development Corp./Jennifer Wilson-Bibbs)
WEST LAFAYETTE, Ind. — Amplified Sciences, a clinical-stage life sciences diagnostic company that develops tests for early, more accurate detection of challenging diseases, starting with pancreatic cancer, has received regulatory clearance under the federal Clinical Laboratory Improvement Amendments (CLIA) program for its first product, PanCystPro™.
The company’s CLIA-certified lab in Irvine, California, is licensed by the California Department of Public Health and will perform the test.
V. Jo Davisson, chief scientific officer of Amplified Sciences, is a professor of medicinal chemistry and molecular pharmacology in Purdue University’s College of Pharmacy and a faculty member of the Purdue Institute for Cancer Research and the Purdue Institute for Drug Discovery. He said PanCystPro helps risk stratify patients with a known precursor for pancreatic cancer — those diagnosed with pancreatic cystic lesions.
“One of the key components of the test is a protease turnover assay for an enzyme that is atypically found in the pancreas, thus providing biological insight into the cyst’s potential for malignancy,” he said.
CEO Diana Caldwell said Amplified Sciences is excited to bring the test to the market to help support clinicians’ decision making.
“According to the Hirshberg Foundation for Pancreatic Cancer Research, pancreatic cancer is the third-deadliest cancer in the United States,” she said. “There are unfortunately few warning signs of the early stages of the disease, thus leading to a low five-year survival rate and the highest mortality rate among all cancers. Pancreatic cystic lesions represent a window to earlier detection of this devastating cancer.”
New milestones and next steps
Caldwell said PanCystPro is the first product in Amplified Sciences’ pipeline to reach the CLIA regulatory hurdle.
“Achieving CLIA regulatory clearance represents an exciting milestone for the company and for the millions of patients diagnosed with pancreatic cystic lesions,” she said. “These cystic lesions represent a challenge for many clinicians, and the use of innovative tests like PanCystPro alongside imaging can provide insights on surveillance and treatment strategies for these patients at higher risk for pancreatic cancer.”
Moving forward, Amplified Sciences will shift its focus to commercializing PanCystPro.
“This includes conducting a pivotal clinical utility trial and providing PanCystPro to a targeted number of health care systems through an early access program in 2025,” Caldwell said. “We also have successfully filed for a PLA code, or Proprietary Laboratory Analyses code, which when approved leads to establishing a payment rate through the Medicare Clinical Lab Fee Schedule process.”
Amplified Sciences and Purdue University
Amplified Sciences’ optical reporter system, BioMatra™, and suite of diagnostic tests are based on innovative technology invented by Davisson. 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 Strategic 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 diagnostic tests that enable earlier detection, risk stratification and monitoring of serious diseases. BioMatra, the company’s ultrasensitive optical reporter platform, leverages technology licensed from Purdue University. Its headquarters is in West Lafayette, Indiana, and the CLIA-certified clinical lab is located in Irvine, California. To learn more about Amplified Sciences, 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 2024, the office reported 145 deals finalized with 224 technologies signed, 466 invention disclosures received, and 290 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 107,000 students study at Purdue across multiple campuses, locations and modalities, including more than 58,000 at our main campus in West Lafayette and Indianapolis. Committed to affordability and accessibility, Purdue’s main campus has frozen tuition 13 years in a row. See how Purdue never stops in the persistent pursuit of the next giant leap — including its comprehensive urban expansion, the Mitch Daniels School of Business, Purdue Computes and the One Health initiative — at https://www.purdue.edu/president/strategic-initiatives.