• ClarityDX Prostate is a validated blood-based diagnostic tool that uses AI-powered learning to help inform patients of their risk for aggressive prostate cancer.
  • Florida-based Protean BioDiagnostics offers ClarityDX Prostate to healthcare providers and their patients suspected of having aggressive prostate cancer.

 EDMONTON, Alberta – ORLANDO, Florida – February 12 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX platform technology, and Protean BioDiagnostics Inc. (Protean) announced today that the American Medical Association (AMA) has issued a new, dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) code for ClarityDX Prostate. ClarityDX Prostate accurately predicts aggressive prostate cancer before a prostate biopsy. The new code 0550U, will become effective April 1, 2025, and is specific to ClarityDX Prostate.

“We are thrilled to receive a unique CPT PLA code from the AMA for ClarityDX Prostate,” said Dr. John Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology at the University of Alberta. “This is a key milestone towards ensuring all patients have access to ClarityDX Prostate to help make more informed decisions about whether to do a prostate biopsy.”

“This is wonderful news for men and their families worldwide, said Dr. Anthony Magliocco, MD, Founder and CEO of Protean BioDiagnostics.  “With this new code, access to ClarityDX Prostate will broaden and have positive life and health systems resources-saving effects. Now, men the world over with their healthcare provider can make faster, accurate decisions and assist greatly in mitigating the risks of prostate cancer”.

In North America, about 1 in 8 men will be diagnosed with prostate cancer and 1 in 44 men will die of prostate cancer, making it the second-leading cause of cancer death in American men. Some prostate cancers are low risk because they grow and spread slowly, while others are aggressive cancers because they grow and spread quickly. When detected early, prostate cancer is one of the most successfully treated types of cancer. When used as an adjunctive test, ClarityDX Prostate helps to identify men with aggressive prostate cancer sooner, leading to better outcomes while also minimizing the negative effects associated with overdiagnosis of the disease.