EDMONTON, June 4, 2019 /PRNewswire/ - Nanostics Inc., a company developing a novel liquid biopsy platform for the early diagnosis of clinically significant prostate cancer, is pleased to announce the start of its key clinical validation study. The study will be carried out with blood to be sampled from 2,800 men with elevated PSA levels. Patient recruitment will be managed by the Alberta Prostate Cancer Research Initiative (APCaRI) and will start in Alberta at Calgary's Prostate Cancer Centre (PCC) and Edmonton's Northern Alberta Urology Centre (NAUC). Recruitment of men from the Yukon Territories will follow.
Previously, a 415-patient prospective clinical study established the validity of this novel liquid biopsy platform and determined it to be 40% more specific than the standard prostate cancer blood screen test, PSA. Nanostics also very recently completed an intensive 2,000 sample stability study with the liquid biopsy blood test to determine the optimal collection and transportation conditions.
This new clinical validation study is part of the process towards meeting FDA and Health Canada requirements for an in vitro diagnostic test, which will allow Nanostics proprietary ClarityDX Prostate test to be provided to patients. The study will be conducted in partnership with DynaLIFE Medical Labs, an award-winning company which provides clinical services for over 2 million patients in its facility in Edmonton, as well as APCaRI at the University of Alberta. The co-principal investigators of this study are Dr. Eric Hyndman (PCC) and Dr. Adrian Fairey (NAUC), both notable urologists and prostate cancer researchers. Funding for the clinical study comes in part from the Motorcycle Ride for Dad, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University Hospital Foundation Kaye Fund.
"We are extremely excited to be moving to the next phase of clinically validating the ClarityDX Prostate test", John Lewis, CEO of Nanostics said, "and we are grateful to all the support we have received here in Alberta to make this possible."
The potential impact of the ClarityDX Prostate test is considerable; implementation could eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50% of unnecessary treatments for prostate cancer in North America. Beyond an estimated cost savings to the healthcare system of more than $1.4B per year, this will have a dramatic impact on the healthcare experience and quality of life for men.
"DynaLIFE is committed to working with innovative technologies that can improve the health outcomes of Albertans" said Jason Pincock, CEO of DynaLIFE Medical Labs, "we are excited to see the results that will come out of the ClarityDX Prostate clinical study and to be working with Nanostics to help improve the diagnosis of prostate cancer."
About Nanostics Inc. Nanostics is a privately held company focused on the development and commercialization of novel and non-invasive diagnostic tests. Our core technology can diagnose disease from a simple blood test by combining a highly sensitive extracellular vesicle (EV) detection platform with advanced machine learning algorithms. Our novel technology is applicable to a wide range of cancers and other diseases. Our lead product, ClarityDX Prostate, is set to become the first clinically validated test using this exciting new EV detection technology.
About DynaLIFE Medical Labs DynaLIFE Medical Labs provides diagnostic laboratory services to more than 2,000 physicians and two million patients annually. The laboratory, locally managed from its state-of-the-art facility in Edmonton, performs more than 14 million tests every year. The laboratory employs the newest technologies to ensure that patients receive the best possible laboratory services.