Netherlands-based Qgen and US-based Exosome Diagnostics have announced an expansion of their strategic partnership for developing non-invasive molecular in-vitro diagnostics for key genetic biomarkers in lung and other cancers.
According to Qgen, the blood based non-invasive test detects certain mutations of an undisclosed gene associated with non-small cell lung cancer and other malignancies. The test has also the potential of pairing with several new anticancer therapeutics.
Through the partnership, Qiagen will have worldwide exclusive rights to commercialize the test. The company is likely to submit the test to the US Food and Drug Administration (FDA) following clinical validation.
Exosome Diagnostics has developed a technology that allows non-invasive detection of key disease associated gene mutations and gene expressions in blood, urine and cerebrospinal fluid without the need for a surgical tissue biopsy.
With the integration of Exosome Diagnostics’ technology with Qiagen’s sample technologies, a cost effective, easy-to-use, and automated sample-to-result workflows is expected to be created for clinical research and healthcare.
Qiagen CEO Peer M Schatz noted the company is excited about this new testing option, which has the potential to expand its existing and future assay portfolio.
"Biofluid-based tests can significantly increase the value of molecular diagnostics in diseases that currently depend on tissue biopsies. We look forward to our expanded collaboration with Exosome and to create solutions for healthcare and science which can improve lives," Schatz added.
Qiagen and Exosome Diagnostics have announced plans in 2013 to introduce the first in a series of high-performance sample preparation kits for processing nucleic acids from biofluid exosomes during the second quarter of 2014.