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ALCMI Providing Samples for Validation of Exosome Dx's Lung Cancer Tests

NEW YORK(GenomeWeb) – Exosome Diagnostics today announced a collaboration with the Addario Lung Cancer Medical Institute in which the ALCMI is providing samples from an ongoing clinical trial to help Exosome advance its plasma-based lung cancer mutation tests.

According to Exosome, the collaboration will support the validation of its ALK and EGFR T790M liquid biopsy diagnostics, which the company plans to launch this year as laboratory-developed tests. The work will also support future development of these assays as IVD kits, Exosome added.

Exosome's technology analyzes cancer-associated RNA biomarkers in circulating extracellular vesicles called exosomes, and in some cases also in circulating DNA. This allows the collection of cancer-associated molecular information without the need for a tissue sample. According to the company, its tests are designed to either complement tissue biopsy analysis or to provide an alternative in cases where repeat biopsies are not practical.

In its collaboration with Exosome Dx, ALCMI is providing the company with matched samples from the Collaborative Advanced Stage Tissue Lung Cancer, or CASTLE trial.

Exosome Chief Medical Officer Vincent O’Neill said in a statement that the company believes the validation performed using these samples will provide "important data to support future regulatory approval of [its] ALK and T790M in vitro diagnostic kits."

"Additionally, we believe these data will help educate clinicians and payers about the potential of our diagnostics to detect, with high sensitivity, rare mutations in order to drive both adoption and reimbursement," he added.

Exosome said it plans to present data from the CASTLE trial samples at the 2015 American Society of Clinical Oncology annual meeting later this year.

In addition to the ALK and EGFR T790M tests, the company also plans to launch a plasma sequencing-based solid tumor panel and a urine-based prostate cancer diagnostic in 2015.