Qiagen, a Netherlands-based holding company, has expanded its strategic partnership with Exosome Diagnostics to develop a first-in-class, non-invasive molecular in-vitro diagnostics for use in diagnosing and monitoring patients.
The novel blood based diagnostic detects certain mutations of an undisclosed gene associated with non-small cell lung cancer (NSCLC) and other malignancies and has the potential to be paired with several new anticancer therapeutics. Qiagen will have worldwide exclusive rights for commercialization and intends to submit the test to the FDA following clinical validation. Financial terms have not been disclosed.
Exosomes are the messenger packages in a fundamental biological communication system that transmits genetic instructions from cell to cell. The technology developed by Exosome Diagnostics allows non-invasive detection of key disease associated gene mutations and gene expressions in blood, urine and cerebrospinal fluid without the need for a risky and burdensome surgical tissue biopsy. The integration of Exosome Diagnostics' technology with Qiagen's proven sample technologies is expected to create cost-effective, easy-to-use and automated sample-to-result workflows for clinical research and healthcare.
In 2013, Qiagen and Exosome Diagnostics announced plans to launch the first in a series of high-performance sample preparation kits for processing nucleic acids from biofluid exosomes during the second quarter of 2014.
"Biofluid-based tests can significantly increase the value of molecular diagnostics in diseases that currently depend on tissue biopsies,” said Peer M. Schatz, CEO of Qiagen.
James McCullough, CEO of Exosome Diagnostics, said, "The ability to perform molecular diagnostic tests on easily accessible biofluids represents an important advance in personalized medicine. It will allow physicians to follow patient's disease status more closely and to provide the best possible treatment."