Revolutionary Tests Powered by Exosome-Isolation Technology to Detect Challenging Cancers from Blood Draw

Highly sensitive and specific approaches for early detection are key for mortality reduction. Consequently, developing tools that enable early disease detection is essential for improving patient survival outcomes. Extracellular vesicles (EVs), a novel class of blood-based, cell-free biomarkers, hold promise for diagnosing cancer at its earliest stages.

Biological Dynamics, Inc. (San Diego, CA, USA) is developing assays for early-stage cancer detection that utilize its patented ExoVerita platform. This platform isolates and analyzes EVs, including exosomes present in patient blood samples. By targeting and isolating exosomes carrying informative biomarkers, the assays can detect specific blood-based exosome protein biomarkers, allowing for highly sensitive early-stage cancer detection.

New data presented by the company suggests the potential for its technology and assays to play a vital role in cancer surveillance and early detection. In a clinical trial evaluating the effectiveness of its ExoVita Pancreas assay for early-stage detection of pancreatic cancer, the assay detected stage 1 and 2 pancreatic ductal adenocarcinoma in 105 confirmed cases (Stage 1 = 39; Stage II = 66) and 545 controls with 93% sensitivity and 91% specificity.

Similarly, a pilot study exploring the potential of liquid biopsy for lung cancer diagnosis based on EVs, the company assessed 143 pathologically confirmed lung cancer cases and 491 controls using a stratified cross-validation approach. The results demonstrated that the company's lung assay, performed on its ExoVerita platform, detected cancer with an overall sensitivity and specificity of approximately 91%.

“We are developing a clinical tool to enable early disease detection in order to improve patient survival outcomes for the most challenging cancers,” said Harmeet Dhani, MD, MSc, Medical Director at Biological Dynamics. “Pancreatic and lung cancers are two of the deadliest cancers in the U.S., as they are often diagnosed in late stages, making treatment more difficult and lowering survival chances. Our data clearly demonstrate the ExoVerita platform, with its assay applications, can detect important cancers earlier than standard of care approaches using a new generation of biomarkers and technology. Surveillance of high cancer risk individuals with these new methods should proceed.”

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Biological Dynamics