HTG Molecular Diagnostics will develop the assay on its proprietary qNPA platform. The PROOF Centre -- a not-for-profit organization focused on developing blood tests for chronic organ disease -- will be involved in the clinical validation in Canada, and provide key opinion leader support for regulatory approval in North America.
Lung attacks are the leading cause of emergency room visits and hospitalizations among chronic disease sufferers, accounting for over $5.7 billion direct, and $6.7 billion indirect healthcare costs every year in Canada alone. According to the World Health Organization (WHO), an estimated 210 million people worldwide have COPD and three million deaths are attributed to the disease annually. WHO predicts COPD will become the third leading cause of death by 2030. A large portion of COPD-related mortality is due to lung attacks.
"The development of these blood tests has been driven by a huge unmet clinical and social need," says Dr. Bruce McManus, Director of the PROOF Centre. "This agreement with HTG Molecular Diagnostics will facilitate bringing these tests to market faster, providing physicians with tools to improve patient care and management and help alleviate suffering of patients with COPD."
Currently, physicians have limited capabilities to predict which COPD patients will suffer frequent lung attacks, episodes that result in hospitalization and a reduced quality of life. The ability to identify these patients earlier will enable physicians to intervene sooner and better tailor treatment for the individual patient to prevent future lung attacks.
TJ Johnson, CEO of HTG Molecular Diagnostics, states, "Delivery of an accurate, early predictor of frequent patient lung attacks, and providing the ability to personalize preventive care is of paramount importance to pulmonology practitioners and patients. This agreement is the first of many that HTG Molecular Diagnostics and PROOF Centre hope to have to bring medically valuable biomarker tests to the clinic."