TEST:

ExoVita™ Pancreas

"Biological Dynamics, Inc...today announced that its ExoLuminate Study is expanding subject enrollment with the addition of four leading institutions in cancer treatment and research: the Dana-Farber Cancer Institute; Moores Cancer Center at UC San Diego Health; University of Florida Health; and MedStar Georgetown....The ExoLuminate Study (NCT05625529) will demonstrate the performance of the ExoVita Pancreas assay for early detection of PDAC in individuals with high risk of pancreatic cancer, as compared to the current standard-of-care methods of surveillance...The new study sites will bring another wave of subject enrollment following the recent collaboration with the PRECEDE Consortium, which is accelerating enrollment of at least 5,000 subjects and approximately 30,000 specimens into the ExoLuminate Study."

"Biological Dynamics...announced a newly published study in Nature’s Communications Medicine titled 'Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma.' The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort."

"Biological Dynamics...will present a 'lightning talk' as part of the 'Understanding Pre-cancers to Enable Early Detection' track at the Early Detection of Cancer Conference, Oct. 10-12, 2023, in London. The session will demonstrate the ability of the ExoVita Pancreas assay to risk-stratify Intraductal Papillary Mucinous Neoplasms (IPMNs), the most common type of pancreatic cyst, in order to help inform treatment decisions for patients at risk of pancreatic cancer."

"Biological Dynamics, Inc...and the Pancreatic Cancer Early Detection (PRECEDE) Consortium...have signed a multi-year agreement to partner on patient surveillance for early-stage pancreatic cancer using Biological Dynamics’ ExoVita Pancreas Assay, powered by the Verita platform."

"Biological Dynamics...will present a poster featuring its ExoLuminate study design, currently enrolling, at The American Society of Clinical Oncology (ASCO), June 2-6, 2023 in Chicago, IL...The detection of pancreatic ductal adenocarcinoma (PDAC) at early-stages is critical to improving patient survival. Pancreatic cancer that is diagnosed in early stages, when it is still localized, has a 5-year survival rate of over 44%, while the 5-year survival rate of cancer that has spread to distant regions is just 3.2%.1 Historically, the lack of a clinically useful biomarker assay has posed a challenge for earlier detection. Today, Biological Dynamics’ liquid biopsy offering, ExoVita™ Pancreas, targets and isolates exosomes from patients’ blood samples to detect the likelihood of developing PDAC. Early studies show that the assay can detect pancreatic cancer at stages I and II, with high sensitivity and specificity."

"Biological Dynamics...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. "

Through this registry, which began enrollment in December 2022 and is open for accrual (NCT0562552), we aim to demonstrate the clinical utility of a novel liquid biopsy based on detection of EV-derived biomarkers for early diagnosis of PDAC which can provide credence to a new paradigm in early detection to improve patient outcomes. Clinical trial information: NCT0562552.

"Biological Dynamics...will present data showing how the company’s ExoVerita™ platform can be utilized for early detection of lung and pancreatic cancers at the American Association of Cancer Research (AACR) annual meeting in Orlando, Fl., April 14-19. A case study of early pancreatic cancer management will also be discussed at the meeting. Biological Dynamics’ will exhibit its technology and early cancer detection assays at booth #1368."

"Biological Dynamics...announced its collaboration with the Brenden-Colson Center for Pancreatic Care at Oregon Health & Science University (OHSU) to study its ExoVita™ Pancreas assay. The Brenden-Colson Center has a robust, integrated clinical-translational interface to drive innovative patient care and nourish scientific collaborations."

"Biological Dynamics...announced completion of the analytical and clinical validation of its lab developed test (LDT), ExoVita™ Pancreas in the company’s CLIA certified and CAP accredited laboratory...Using blood-based exosome samples enriched on the proprietary ExoVerita instrument, the ExoVita Pancreas assay measures specific exosomal protein biomarkers and has been demonstrated to detect Stage 1 and Stage 2 pancreatic ductal adenoma carcinoma (PDAC)."