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Qiagen, Exosome Diagnostics Expand Partnership to MDx Development

NEW YORK (GenomeWeb News) — Qiagen and Exosome Diagnostics said today that they have expanded their collaboration to develop non-invasive in vitro molecular diagnostics.

The diagnostics will be based on Exosome's proprietary methods for purifying nucleic acids from biofluid exosomes and other microvesicles with Qiagen's sample prep technologies to create "cost-effective, easy-to-use, and automated sample-to-results workflows," the companies said in a statement.

Qiagen and Exosome will first develop a blood-based test to detect certain mutations of an undisclosed gene associated with non-small cell lung cancer and other malignancies. The assay will have the potential to be paired with several new anticancer therapies, the companies said.

Qiagen will have worldwide exclusive commercialization rights and intends to submit the test to the US Food and Drug Administration following clinical validation.

Financial terms of the agreement were not disclosed.

Qiagen and Exosome first disclosed in July that they would partner to develop and commercialize co-branded kits to capture and process RNA and DNA from biofluids.

The kits will allow researchers, drug developers, and doctors to take repeated, real-time genetic "snapshots" of disease from patients' blood, urine, or cerebrospinal fluid without the need for tissue biopsy, and will be designed to run on "widely available" PCR, pyrosequencing, and next-generation sequencing technologies, the companies said.

The companies reiterated this week that they plan to launch the first of these kits in the second quarter of this year.