Exosome Diagnostics, Inc., a developer of biofluid-based molecular diagnostics, has announced a strategic collaboration with the Addario Lung Cancer Medical Institute (ALCMI) to accelerate the development of its lead plasma-based diagnostics in development for mutation detection and monitoring in patients with lung cancer. The collaboration will support validation of Exosome Diagnostics’ ALK and T790M lab-developed tests (LDTs) planned to launch this year and help advance future development of the company’s ALK and T790M in vitro diagnostic (IVD) kits.
Exosome Diagnostics’ ALK and T790M tests have the potential to provide clinicians with real-time, precise molecular insights to help inform individualized treatment decisions for patients with lung cancer upon initial diagnosis and throughout the course of treatment. As liquid biopsy tests, these diagnostics analyze biomarkers in blood plasma, providing molecular information about cancer cells in the body without needing direct access to the actual cells. They are designed to complement tissue biopsy and provide an important alternative to monitor for emerging mutations when repeat biopsies are not practical or feasible.
Exosome Diagnostics’ technology platform enables the development of tests that can analyze stable, high-quality exosomal RNA (exoRNA), representing a potentially important advance given that many known cancer mutations, such as gene arrangements and splice variants, are difficult or impossible to detect utilizing circulating DNA analysis. For certain mutation targets where the addition of the circulating DNA fraction would enhance the sensitivity of detection, Exosome Diagnostics’ platform offers the versatility to create tests that can simultaneously capture and analyze exoRNA and cell-free DNA (cfDNA).
ALCMI has assembled a consortium of leading clinical centers into a cooperative network to drive the molecular understanding of lung cancer in several clinical trials, including the Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) trial, from which the samples for this collaboration are derived.Learn more at the Exosome website