Product News: Rheonix to Highlight First Fully Automated FFPE KRAS-Biomarker Assay at BIO International Convention

20 Jun 2012

Rheonix, Inc. a molecular diagnostics company, has announced that it will present data on its fully automated KRAS CARD™, the latest oncology application of the Company’s powerful molecular diagnostic platform. The KRAS CARD is designed to detect somatic mutations of the KRAS oncogene from either fresh or formaldehyde fixed-paraffin embedded (FFPE) tissue samples automatically on the EncompassMDx™ system.

Patients undergoing colorectal cancer therapy are commonly screened, using a complex, labor intensive molecular assay for the biomarkers KRAS, which are predictive of the effectiveness of anti-EGFR drug therapy. The KRAS CARD assay is not cleared for diagnostic use by the FDA.

“Fully automated molecular diagnostic platforms, such as Cepheid’s GeneExpert®, have transitioned assays from high complexity to moderate complexity allowing for wider adoption and use,” said Tony Eisenhut, President of Rheonix, Inc. “Until now, there has not been a fully automated system that could process the raw sample types required of molecular oncology assays. Our Encompass platform not only reduces the amount of time necessary to perform a KRAS assay, but it also has the potential to reduce the cost of these assays and enable a broader use in the clinic.”

Eisenhut continued, “Our novel assay for the detection of KRAS mutations has shown to achieve analytical sensitivity down to 0.1% as compared to current benchtop molecular assays which are capable of detecting 1% mutation. This high sensitivity is not only valuable as a research tool for those developing anti-EGFR therapies, but in time it has the potential to improve the standard of care in the clinic.”

This new data highlights the ability of the KRAS CARD to process FFPE samples for the presence of seven known somatic mutations of KRAS. The KRAS CARD was loaded with approximately 10 mg of tissue microtomed from an FFPE tissue block. All steps, including tissue deparaffinization and decrosslinking, cell lysis, DNA purification, molecular amplification, and endpoint detection were performed automatically without need for technician intervention. Results were obtained in four hours. Based on this data, the KRAS CARD has the potential to provide a KRAS genotyping assay that is automatic, sensitive, and affordable—characteristics that are unmatched in today’s available assays.

Rheonix will present the data at the BIO International Convention, on Wednesday 20th June, 2012 in Boston, Massachusetts.