Exosome Diagnostics Selects Promega Corp. for cGMP Clinical Sample Concentrator Kit
NEW YORK, Oct. 26, 2012 – Exosome Diagnostics today announced it has reached an agreement with Promega Corporation to be the exclusive supplier of its Urine Clinical Sample Concentrator Kit. Promega will manufacture the Clinical Sample Concentrator Kit under current good manufacturing practices (cGMP) in their Madison, Wisconsin manufacturing facility. The kit incorporates Exosome’s proprietary method for concentration of urinary exosomes, a standardized approach for providing clinical laboratories access to high quality preparations suitable for molecular diagnostics. The kit will be used to process urine samples for clinical trials in genitourinary disorders, including prostate cancer.
“This agreement is another important milestone in the execution of our molecular diagnostics commercial strategy,” said James McCullough, chief executive officer of Exosome Diagnostics. “It is essential for our customers that we deliver the highest degree of quality and reproducibility in our molecular diagnostic products. We’re pleased to be working with Promega, a manufacturer who has decades of experience in coupling the latest scientific advances in molecular biology with excellent cGMP manufacturing capability. Promega’s high quality products have proven themselves in meeting the manufacturing demands within both the life science and diagnostics market.”
Exosomes are microvesicles that are released by cells into the extracellular environment and contain important biochemical and molecular information reflecting the status of the cell of origin. Exosome Diagnostic’s researchers have pioneered microvesicle isolation and processing methods that preserve the integrity of the nucleic acids derived from the exosomes, yielding high quality nucleic acid preparations suitable for diverse types of molecular analysis. The company is pursuing development of non-invasive molecular diagnostics based on microvesicles for both detecting and monitoring disease.
“Exosome Diagnostics’ non-invasive molecular testing technology is at the forefront of personalized medicine. Our IVD manufacturing team understands the process required to create such a critical test,” said Bill Linton, chief executive officer of Promega. “Advances like these in the diagnostics market will continue to make positive contributions for both health practitioners and patients.”
About Exosome Diagnostics
Exosome Diagnostics is a leading developer of fluid-based molecular diagnostic tests for use in personalized medicine. Exosomes and other microvesicles are packaged and shed into all biofluids, including blood, urine and cerebrospinal fluid, providing a stable source for intact, disease-specific genetic material. The company’s proprietary exosome technology makes use of the presence and natural stability of RNA in exosomes to detect and measure levels of genes responsible for cancer and other diseases. For more information, please visit www.exosomedx.com.
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 2,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, molecular diagnostics and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 15 countries and over 50 global distributors. For more information about Promega, visit www.promega.com.