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HTG Validating PROOF Centre's Heart Transplant Rejection Assay

NEW YORK (GenomeWeb News) – HTG Molecular Diagnostics today announced a collaboration to validate the Centre of Excellence for the Prevention of Organ Failure's (PROOF Centre) assay for organ rejection in heart transplant patients.

HTG will use the HTG Edge System in the clinical laboratory of St. Paul's Hospital, Providence Health Care in Vancouver, British Columbia to start clinical validation of the PROOF Centre's molecular biomarker test, which is intended to help physicians better monitor and treat patients after a heart transplant.

HTG's platform automates RNA analysis and delivers extraction-free, multiplexed results on a number of biological samples in 24 hours, the Tucson, Ariz.-based company said, adding the HTG Edge System enables the analysis of up to 47 different genes from minimal specimen volume.

The terms of the deal also call for the PROOF Centre to work with HTG to prepare for regulatory approval in North America. Funding for clinical validation of the assay is provided by the PROOF Centre, Genome British Columbia, Provincial Health Services Authority, Providence Health Care Research Institute, Vancouver Coastal Health Research Institute, and the Transplant Research Foundation of BC.

"This collaboration with PROOF will result in the timely and localized assessment of a patient's heart failure risk due to rejection," HTG CEO TJ Johnson said in a statement. "The marriage of HTG Edge RNA analysis platform and PROOF Centre's meticulous research will provide a testing mechanism to replace technology now available only at specialty laboratories."

Last November, HTG said it was licensing technology from the PROOF Centre to develop and commercialize a COPD test.

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