Biological Dynamics Case Report Published in Frontiers in Oncology Demonstrates Advancement in the Detection of Early-Stage Pancreatic Lesions

2023-05-26

临床结果

SAN DIEGO--(BUSINESS WIRE)--Biological Dynamics, a life sciences company focused on developing and commercializing exosome isolation technology for earlier disease detection, today announced the publication of a case report, “Early detection of pancreatic pre-cancer lesion in multimodal approach with exosome liquid biopsy,” in Frontiers in Oncology, highlighting the successful detection of early-stage pancreatic ductal adenocarcinoma (PDAC) lesions using its exosome liquid biopsy assay, ExoVitaTM Pancreas.

'What is clinically significant about this case report is that the ExoVita Pancreas detected a pancreatic lesion, which has high potential to become malignant very rapidly'

The case report suggests that the high sensitivity and specificity of the ExoVita Pancreas for early-stage PDAC detection have the potential to improve patient survival outcomes significantly. Pancreatic cancer is currently the third-leading cause of cancer-related death in the United States,1 with a 5-year survival rate of just 12.5%.2 The earlier pancreatic cancer is diagnosed and treated, the better the prognosis. Unfortunately, pancreatic cancer usually shows little or no symptoms until it has advanced and spread. As a result, it is often diagnosed in late stages, leaving patients and clinicians with limited treatment options, which lowers the chances of survival.

“What is clinically significant about this case report is that the ExoVita Pancreas detected a pancreatic lesion, which has high potential to become malignant very rapidly,” said Harmeet Dhani, M.D., M.Sc., Medical Director of Biological Dynamics. “In this case, our assay, which was initially trained on stage I and II pancreatic cancer patient samples, successfully detected exosomes from an early-stage lesion. This demonstrates the potential to use our assay in conjunction with other diagnostic modalities to help make a diagnosis at very early stages, when treatment is most likely to improve patient outcomes.”

The case report profiles a 60-year-old, healthy, non-Hispanic white male who presented with acute pancreatitis. The patient underwent ten months of invasive procedures and testing that failed to detect radiographic evidence of pancreatic lesions or identify disease concerns. However, the ExoVita Pancreas assay resulted in a “high likelihood of PDAC.” Surgical pathology confirmed the diagnosis of high-grade intraductal papillary mucinous neoplasm (IPMN), which was consistent with the ExoVita Pancreas results. Additionally, a post-operative ExoVita Pancreas signature result was not detected, demonstrating that biomarkers had decreased and corroborating the patient’s disease-free clinical picture after a successful surgery.

The current standard of care for IPMN patients is a “watch-and-wait” approach that includes invasive, frequent scans and chronic symptom monitoring. Adding ExoVita Pancreas could allow physicians to more confidently direct patient treatment options for both high and low-risk patients.

Early data demonstrate the ability to use Biological Dynamics’ ExoVerita exosome isolation platform to detect cancer earlier using a new generation of biomarkers and technology, which is especially important for high-risk patients. The ExoVita Pancreas test, which targets and isolates exosomes found in patient blood samples, detected cancer at stages I and II with high sensitivity and specificity in prior studies, and now has the potential to detect precancerous lesions as well.

About Biological Dynamics

Biological Dynamics, Inc. is committed to improving global health outcomes by detecting diseases at the earliest stages. Its proprietary exosome-isolation ExoVerita™ platform, currently used by the company and research customers, simplifies isolation of extracellular vesicles, enabling multiomic applications. Biological Dynamics recently initiated its ExoLuminate study to demonstrate the effectiveness of its ExoVita™ Pancreas assay for early-stage detection of pancreatic cancer. The assay is a lab-developed test (LDT) validated and performed in the Company’s College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. All clinical decision making remains with patient and their physicians. Learn more at www.ExoLuminate.com.

References:

American Cancer Society: Cancer Facts & Statistics. American Cancer Society | Cancer Facts & Statistics. https://cancerstatisticscenter.cancer.org. Accessed May 17, 2023.

Cancer Stat Facts: of the pancreas – Pancreatic Cancer. National Cancer Institute. SEER. https://seer.cancer.gov/statfacts/html/pancreas.html. Accessed May 17, 2023.