Exosome Diagnostics plans to validate the ABI instrument platform with exosome biofluid RNA isolation technology kits in upcoming multi-center clinical trials in brain cancer 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.
"Our product development strategy is to match our exosome-based diagnostics technology with the most technically appropriate and widely accepted platforms available," said David Okrongly, chief operating officer of Exosome Diagnostics. "The ABI 7500 Fast Dx Real-Time PCR Instrument from Life Technologies combines state of the art quantitative PCR (qPCR) technology with broad market and regulatory acceptance, enabling physicians and laboratory customers to efficiently and accurately access diagnostic results."
Ron Andrews, president, Medical Sciences at Life Technologies added, "We are pleased to be partnered with Exosome Diagnostics as they develop their non-invasive cancer diagnostic programs. Our Medical Sciences strategy is focused on partnerships with emerging companies that have promising molecular diagnostic applications that enable the realization of personalized medicine in diseases like cancer."
Exosome Diagnostics is developing a series of urine and blood-based molecular diagnostic tests for use in cancer detection and monitoring. Exosome Diagnostics' technology provides the ability to isolate a highly pure, stable preparation of ribonucleic acids from biofluids for analysis on existing analytical platforms such as qPCR and next-generation sequencing. The Company is currently in the process of partnering with various manufacturing groups to provide branded, OEM in-vitro diagnostic solutions for regulatory approval and use in the Company's GLP 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, chief executive officer 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 pre-requisites to the successful launch of innovative molecular diagnostics."