FDAnews Device Daily Bulletin

Qiagen, Exosome Expand Strategic Partnership to Develop Cancer Diagnostics

Jan. 16, 2014

Qiagen and Exosome Diagnostics have expanded a strategic partnership, with the aim of developing first-in-class, non-invasive, in vitro molecular diagnostics.

The program marries Qiagen’s sample preparation kits with Exosome’s noninvasive diagnostics, which can detect known cancer markers and tumor mutation status through easily accessible body fluids such as urine, blood and cerebrospinal fluid. The focus will be on detecting mutations associated with non-small cell lung cancers and other malignancies.

Such personalized cancer technology has the ability reduce both the cost of treatment and the risk to the patient, the companies said. The tests could be paired with targeted cancer treatments.

Qiagen will prepare the sample preparation kits, while Exosome will contribute the diagnostic expertise, Qiagen spokesman Thomas Theuringer told Device Daily Bulletin. The tests will both contribute to the company’s assay portfolio and expand its presence in the personalized healthcare field, he said.

Qiagen plans to submit the first test to the FDA for approval once it is clinically validated and will be responsible for marketing the tests.

Financial terms of the arrangement were not disclosed. Last year, the companies said they would introduce sample preparation kits for processing nucleic acids from biofluid exosomes in the second quarter of 2014. — Lena Freund

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