Exosome Diagnostics has expanded its strategic collaboration withQiagen to develop non-invasive molecular diagnostics for use in detecting and monitoring actionable genetic mutations in lung cancer patients. In contrast with current molecular diagnostics requiring tissue biopsy, the focus will be to enable detection of well-understood cancer biomarkers in plasma, reducing both cost and patient risk. Financial terms of the collaboration were not disclosed.
The programme will focus on detection of known mutations associated with non-small cell lung cancer (NSCLC) and other malignancies that have the potential to be paired with targeted therapies.Qiagen plans to submit the first diagnostic test developed under the collaboration to the Food and Drug Administration following clinical validation.
"The ability to perform molecular testing in blood represents an important advance in personalized medicine," said James McCullough, chief executive officer of Exosome Diagnostics. "QIAGEN is the ideal partner to bring robust, regulated exosome technology products to the global clinical market place."
Exosome Diagnostics' proprietary technology is focused on rapid, robust isolation of clinically actionable genetic biomarkers from blood, urine and cerebrospinal fluid for diagnosis, monitoring and companion diagnostic applications. The Company's clinical in vitro diagnostic products are designed to operate on widely available sequencing and PCR instruments. Exosome Diagnostics intends to launch the first in a series of blood-based mutation diagnostics in its CLIA laboratory beginning in 2014.
Exosomes are the messenger packages in a fundamental biological communication system that transmits genetic instructions from cell to cell. The unique 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 surgical tissue biopsy.
Exosome Diagnostics is a leading developer of biofluid-based molecular diagnostic tests for use in personalized medicine.