SQI Diagnostics Inc, (SQI) a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, and Predictive Health Diagnostics Co., (PHD) an Irvine, CA-based pioneer in the field of predictive diagnostic medicine, announced the validation, commercial transition, and successful installation of SQI’s automated sqidlite system to run PHD’s multi-biomarker cardiac event prediction assay in PHD’s CLIA laboratory in Irvine, California, where PHD is already servicing thousands of patients annually.
SQI has transformed 7 of PHD’s 9 biomarkers for the PULS Cardiac Test (the “PULS Test”) into an SQI-based multiplex test with kits being manufactured at SQI’s state-of-the-art facility in Toronto. The sqidlite system and test kits will also be available to PHD’s global customer base for purchase to run the PULS Cardiac test in their own laboratories. These PHD customers are some of the world’s most recognized cardiologists, hospitals, and reference laboratories around the world such as the world-renowned Cleveland HeartLab (Cleveland, OH), LifeLabs (Toronto, ON) and many others.
The PULS Cardiac Test marks a major advancement in medicine’s ability to predict the chances of a heart attack before it happens and enable prevention. It is the first test of its kind to integrate quantification of the body’s immune system response to endothelial damage to identify subclinical residual cardiac risk and predict a 5-year risk of heart attack. The test was published in summary form in the November 2014 edition of the Journal of the American Association of Clinical Endocrinologists.
“We’re excited to be the technology platform upon which PHD’s Cardiac PULS test is now based,” said Andrew Morris, CEO of SQI Diagnostics. “We believe the Predictive Health Diagnostics PULS Cardiac test will transform the way cardiovascular testing and cardiac event prediction is performed. Clearly, the commercial potential for PULS is very promising as is illustrated by the esteemed and growing list of customer clinics using this important predictive diagnostic tool. The potential market for this test is everyone over the age of 40 and as young as 35 for people that have known risk factors such as family history. Predictive Health Diagnostics estimates that the market for the PULS test could exceed 100 million tests per year.”
Dr. Douglas Harrington, chief executive officer of PHD said, “SQI is the perfect partner for PHD and the PULS assay. We needed a partner that takes test quality and patient health as seriously as we do. We need proven expertise in developing and gaining FDA-clearance of multiplexed tests. SQI also has ISO and cGMP-quality standards in its product development and manufacturing. Finally, we need our partner to have scaled a range of automated systems with different capacities including a sophisticated automated system to run these tests, reduce our labor costs and simplify workflows. SQI clearly has all of these attributes, and we look forward to growing both of our businesses through this commercial partnership.”