FDA Grants Breakthrough Device Designation for Biological Dynamics’ Early-stage Pancreatic Cancer Detection Test

Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults

SAN DIEGO--(BUSINESS WIRE)--Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its liquid biopsy assay, Exo-PDAC. The test is designed to provide early detection for pancreatic ductal adenocarcinoma (PDAC), one of the most aggressive and lethal forms of cancer worldwide.

“Early detection of pancreatic cancer in elevated risk individuals may help save a lot of lives,” said Scott Lippman, MD, Director of Moores Cancer Center at UC San Diego Health. “The promise of Biological Dynamics’ cutting-edge exosomal isolation technology is addressing a critical, unmet medical need in our multidisciplinary and multi-dimensional fight against pancreatic cancer.”

PDAC is projected to become the second leading cause of cancer-related deaths by 2040, due primarily to the fact that the disease is asymptomatic in its early stages. Therefore, patients are typically diagnosed during advanced stages of disease progression when treatments are limited. Detecting early PDAC biomarkers could help identify vulnerable patients before the disease progresses or metastasizes. However, it requires a high degree of sensitivity and specificity that conventional laboratory testing methods lack.

The Exo-PDAC diagnostic assay identifies exosomal biomarkers related to an elevated risk of pancreatic cancer, such as individuals with new-onset diabetes, a family history of pancreatic cancer, certain germline mutations, and other relevant factors that might be determined by the United States Preventive Services Task Force (USPSTF). Exo-PDAC is the first assay to use Biological Dynamics’ Verita™ platform, a novel alternating current electrokinetic-based technology applied for early disease detection, including cancer, Alzheimer’s disease, and infectious diseases. The test requires a small amount of blood from patients, which is then analyzed with minimal sample preparation or processing.

“For far too long, patients have needed innovative technologies with the potential to detect cancer at the earliest stages, and we look forward to working closely with the FDA, to do exactly that, with our pancreatic cancer test,” said Biological Dynamics CEO Raj Krishnan, PhD. “And for us, this is an important milestone as we accelerate our vision of improving global health outcomes by advancing our unique multiomics platform for multiple cancers and other diseases.”

According to the FDA, “The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

About Biological Dynamics
Biological Dynamics, Inc. is a multiomics liquid biopsy company committed to improving global health outcomes by detecting diseases at their earliest stages. The company's proprietary Verita™ platform simplifies access to biomarkers, nanoparticles, and nucleic acids, enabling differentiated multiomics applications. The company is applying its platform technology along with machine learning to detect cancers in blood and other highly conductive solutions. It operates a CAP/CLIA laboratory in San Diego, CA. For more information, please visit www.biologicaldynamics.com and follow us at @BiodynSD on Twitter.

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Kevin Han 
Chief Financial Officer 
kevin.han@biodyn.io