TUCSON, Ariz., Sept. 21, 2015 — HTG Molecular Diagnostics, Inc., a provider of instruments and reagents for molecular profiling applications, announced it has formed a technology partnership with The Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) for an RNA-based liquid biopsy from peripheral blood, utilizing the NGS-based HTG EdgeSeq system. The heart transplant rejection blood test is intended to provide early indication of organ rejection in heart transplant patients, allowing doctors to better monitor and treat patients post-transplant. PROOF Centre is preparing to initiate clinical validation studies for their HTG EdgeSeq-based blood test, beginning at St. Paul’s Hospital in Vancouver, Canada.
“The development of this blood test was driven by demand from patients who typically have to undergo at least 12 invasive biopsies per year in the first year post-transplant. Currently, there is no globally accepted, affordable blood test available for monitoring heart transplant patients,” says Dr. Bruce McManus, PROOF Centre CEO. “The heart transplant rejection blood test developed by PROOF Centre and deployed on the HTG platform will allow doctors to test patients during this crucial period.”
PROOF Centre will also use the HTG EdgeSeq system for organ failure research, clinical trials and the development of gene expression based tests. These tests will stratify patients based on message RNA (mRNA) and microRNA (miRNA) expression in challenging sample types such as PAXgene, formalin-fixed, paraffin-embedded (FFPE) tissues and plasma from blood.
Human organ failure represents the single largest contribution to patient mortality and associated healthcare cost, globally. HTG expects its technology partnership with PROOF Centre to provide critical insights and tools to help physicians in their management of patients.
“We are thrilled to partner with PROOF Centre in development of this liquid biopsy test to improve heart transplant outcomes and to continue efforts to address systemic organ failure,” stated TJ Johnson, HTG’s Chief Executive Officer.
About HTG Molecular Diagnostics:
Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG Edge system capabilities have been expanded to fully automate sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.
About PROOF Centre:
The Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) develops blood tests to diagnose and better treat and manage heart, lung and kidney disease. PROOF Centre is a cross-disciplinary engine of partners representing academia, health care, government, industry, patients and the public, focused on improving health and reducing the enormous socioeconomic burden of heart, lung and kidney disease. A not-for-profit society established in March 2008 by competitive funding from the Networks of Centres of Excellence Secretariat under the Centre of Excellence for Commercialization and Research (NCE CECR) Program, PROOF Centre is co-hosted by the University of British Columbia and Providence Health Care (St. Paul’s Hospital) in Vancouver, British Columbia, Canada. For more information, visit www.proofcentre.ca.
Safe Harbor Statement:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the use of HTG’s technology by PROOF Centre, the expected benefits and capabilities of HTG’s technology, and the expected benefits of HTG’s technology partnership with PROOF Centre . Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks inherent in molecular profiling research and development activities. These and other factors are described in greater detail in HTG’s quarterly report on Form 10-Q for the quarter ended June 30, 2015, filed with the Securities and Exchange Commission on August 7, 2015. All forward-looking statements contained in this press release speak only as of the date on which they were made, and HTG undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.