Exosome Diagnostics to Validate Life Technologies Platform for Biofluid Isolation Kits

Exosome Diagnostics (New York, NY, USA) has reached an agreement with Life Technologies (Carlsbad, CA, USA) to use the Applied Biosystems (ABI) 7500 fast Dx real-time polymerase chain reaction (PCR) instrument for the company’s exosome biofluid in vitro diagnostics oncology program. Exosome Diagnostics plans to validate the ABI instrument platform with exosome biofluid RNA isolation technology kits in multicenter clinical trials in brain and prostate cancer beginning in 2012.

The ABI 7500 fast Dx real-time PCR instrument is one of the most widely distributed PCR platforms in laboratories worldwide and is cleared by the Food and Drug Administration (FDA; Silver Spring, MD, USA).

Exosome Diagnostics is developing a series of urine and blood-based molecular diagnostic tests for use in cancer detection and monitoring. The company's technology can isolate a highly pure, stable preparation of ribonucleic acids from biofluids for analysis on existing analytical platforms such as real time quantitative PCR (qPCR) and next-generation sequencing. The company is partnering with various manufacturing groups to provide branded, original equipment manufacturer (OEM) in vitro diagnostic solutions for regulatory approval and use in the its good laboratory practice (GLP) clinical laboratory improvements amendments (CLIA)-certified laboratory.

"This agreement with Life Technologies continues our pursuit of best-in-class partnerships that include the Prostate Cancer Foundation, Accelerate Brain Cancer Cure and the broad group of leading clinical investigators now collaborating on exosome technology," said James McCullough, CEO of Exosome Diagnostics. "Life Technologies is leading the way in personalized medicine and provides us with the type of customer service and robust technology that are prerequisites to the successful launch of innovative molecular diagnostics."

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Exosome Diagnostics
Life Technologies
Food and Drug Administration