Skip to main content
Premium Trial:

Request an Annual Quote

Exosome Dx Opens CLIA Lab in Massachusetts

NEW YORK (GenomeWeb) – Exosome Diagnostics today said that it has opened a CLIA-certified laboratory in Cambridge, Massachusetts.

The lab has taken over functional operations of the firm's now-shuttered CLIA facility in St. Paul, Minnesota and expanded its efforts to provide clinicians with access to molecular diagnostics tests, Exosome said. It added that the lab will manage analysis and reporting for liquid biopsy tests planned for launch this year for prostate, lung, and other solid tumor cancers.

The firm is developing plasma- and urine-based liquid biopsy tests for analyzing exosomal RNA for biomarkers. According to Exosome, its technology offers the ability to isolate and analyze exoRNA and cell-free RNA and cell-free DNA to improve the detection of mutations.

The company plans this year to launch two blood-based lung cancer liquid biopsy tests to detect ALK and T790M mutations to match patients with the most appropriate targeted therapies or clinical trials. Exosome also plans to commercialize a urine-based liquid biopsy test aimed at reducing unnecessary prostate biopsies by predicting which patients do not have high-grade prostate cancer.

The tests will be made available as laboratory-developed tests with analysis performed at the Cambridge laboratory. Exosome said that it expects eventually to launch in vitro diagnostic test kits that can be run in other labs.

"We are taking this important step to centralize our operations at our US corporate headquarters in Cambridge as we work to seamlessly launch new molecular diagnostics, while also accelerating our technology platform to other important disease areas," Exosome CEO Thomas McLain said in a statement.

The firm added that it anticipates launching its diagnostic tests in Europe next year, which will be run out of the company's Munich laboratory.