Qiagen and Exosome Diagnostics to develop diagnostics for genetic biomarkers in cancers

Qiagen and Exosome Diagnostics have expanded their strategic partnership to develop non-invasive, in-vitro molecular diagnostics for detecting and monitoring actionable genetic mutations in lung-cancer patients. Qiagen will have worldwide exclusive rights for commercialisation and plans to submit the test to the US FDA following clinical validation.

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. The 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 new anticancer therapeutics.

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 surgical tissue biopsy. The company’s clinical in-vitro diagnostic products are designed to operate on widely available sequencing and PCR instruments. The integration of the technology with Qiagen’s sample technologies is expected to create cost-effective, easy-to-use and automated sample-to-result workflows for clinical research and healthcare.

Peer M Schatz, CEO of Qiagen, said, “Biofluid-based tests can significantly increase the value of molecular diagnostics in diseases that currently depend on tissue biopsies.” Exosome Diagnostics CEO James McCullough added, “The ability to perform molecular diagnostic tests … will allow physicians to follow patients’ disease status more closely and to provide the best possible treatment.”

The companies last year announced plans to launch the first in a series of high-performance sample preparation kits for processing nucleic acids from biofluid exosomes.