Amplified Sciences earns key clearance for cancer diagnostic test
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A West Lafayette-based life sciences diagnostic company has received federal regulatory clearance for its first product aimed at early detection of pancreatic cancer.
Amplified Sciences said the clearance under the Clinical Laboratory Improvement Amendments, or CLIA, program is a key step toward commercialization.
The startup was founded by V. Jo Davisson, a Purdue professor of medicinal chemistry and molecular pharmacology. The company’s PanCystPro product uses proprietary, ultrasensitive dyes that can detect biomarkers in a small amount of pancreatic cyst fluid.
Pancreatic cystic lesions are precursors to pancreatic cancer, and Amplified Sciences’ platform aims to assist health care providers in deciding early whether a patient’s pancreatic cyst is benign or malignant, and whether removal is needed.
“According to the Hirshberg Foundation for Pancreatic Cancer Research, pancreatic cancer is the third-deadliest cancer in the United States,” CEO Diana Caldwell said in a news release. “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.”
Amplified Sciences already has a CLIA-certified lab in Irvine, California. With the CLIA approval for PanCystPro, the company said it will now shift its focus to commercializing the product through more testing.
“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 Proprietary Laboratory Analyses code, which when approved leads to establishing a payment rate through the Medicare Clinical Lab Fee Schedule process.”
The clinical trial is set to be performed at the California lab.
The approval comes just three months after Amplified Sciences closed on a $2.6 million round of seed funding, led by Elevate Ventures in Indianapolis and Chicago-based OCA Ventures.