Amplified Sciences Earns CLIA Certification for Its First Test to Assess Pancreatic Cancer Risk
Company to commercialize PanCystPro, including establishing an early access program and completing a clinical utility trial in 2025
WEST LAFAYETTE, IN — 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.”
- This press release was originally published by Purdue University