New non-invasive test for prostate cancer may identify severity of tumor also

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Illustration of exRNA and exosomes from the National Institutes of Health

Illustration of exRNA and exosomes from the National Institutes of Health

Exosome Diagnostic, Inc., has developed a revolutionary non-invasive approach to molecular diagnostic testing that is gaining popularity, especially in the field of prostate cancer detection and prognosis. The company, based in New York, was founded in 2008 and has licensed its proprietary exosome technology from Massachusetts General Hospital for use in the development of novel biofluid-based in vitro diagnostic tests.

Exosomes are produced in cells throughout the body and carry intact disease-specific nucleic acids that can be used to diagnose certain conditions. These exosomes are shed into bodily fluids such as urine and blood, which can be collected easily for analysis. As opposed to current diagnostic methods, the abundance and natural enrichment of RNA in exosomes allows for ease in isolation and identification of genes (especially rare transcripts) responsible for cancers and other diseases. This is another step in the direction of personalized medicine.

Exosome Diagnostics, Inc. has recently conducted a multi-center clinical study program for EXO106, the first in vitro urinary exosome-derived RNA diagnostic for prostate cancer. Current diagnostic procedures for prostate cancer involve a prostate massage by the physician that can be uncomfortable to the patient and give highly variable results.

The current diagnostic evaluates prostate-specific antigen (PSA) levels in the blood, which also can be an inaccurate measure for prostrate cancer. Unfortunately, based on the ambiguous results, the patient would have to undergo a painful biopsy to confirm the diagnosis. There are often false positives making the entire ordeal painful and expensive .

EXO106 is a non-invasive in vitro diagnostic test for a novel four gene prostate cancer signature. It could not only successfully predict a positive biopsy but also classify the severity of the tumor by distinguishing less aggressive, lower Gleason scores cancers from those with higher, more aggressive Gleason scores. The diagnostic could also be used for real-time monitoring of the tumor response to anti-cancer treatments.

CEO and founder James R. McCullough has led the company since its inception. His experience includes developing diagnostics for kidney and cardiovascular diseases. Johan Skog, PhD, was appointed CSO in July 2010 and has served the company in various roles such as Director of Research and Consultant since 2008. His work in neurology at Massachusetts General Hospital showed that tumor derived mutations can be detected in the microvesicle RNA from serum and other biofluids.

Exosome Diagnostics said in a regulatory filing in June 2013 that it has raised $6.5 million toward a targeted $8 million financing round. The capital was raised by issuing debt securities, options, warrants and other rights to acquire other securities to two investors. In 2010, Exosome Diagnostics, Inc., had raised $20 million co-led by NGN Capital, and Forbion Capital Partners. The company intends to use the proceeds to further develop and commercialize a series of next-generation biofluid-based diagnostics.

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By Sandra Lobo

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