Nanostics re-opens ClarityDX prostate clinical study with new US recruitment site

Summary

• Nanostics’ clinical validation study for ClarityDX Prostate, a liquid biopsy test for the early diagnosis of clinically significant prostate cancer, re-opens recruitment after lifting of COVID-19 research restrictions
• A top-ranked research institute in the Northeast US will now partner with Nanostics’ by recruiting patients for the clinical validation study
• This partnership will significantly accelerate the clinical study timeline and promote patient cohort diversity

Edmonton, Alberta, June 16, 2020 – Nanostics Inc (“Nanostics”) announced today the re-opening of their clinical validation study testing ClarityDX Prostate in a real-world setting. The study is also greatly benefiting from further expansion into the US with the addition of a new patient recruitment site at an award-winning United States clinical research institution (“Partner”). ClarityDX Prostate is a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer. Nanostics is excited to work with this Partner to reach the recruitment numbers and diversity goals of the clinical study.

Nanostics now has five recruitment sites for its pivotal clinical validation study for ClarityDX Prostate spanning across North America with three in Canada (Calgary and Edmonton, Alberta plus Whitehorse, Yukon), and now two in US (Florida and Northeast US).

The Alberta Prostate Cancer Research Initiative (APCaRI) co-sponsored clinical validation study is targeting the recruitment of 2,800 patients with elevated levels of prostate specific antigen (PSA). The agreement with this Partner to recruit 200 patients will significantly accelerate the clinical study timeline and further enhance patient diversity of the cohort.

Funding support for the inclusion of US patient samples into the clinical study comes from the Bird Dogs for Prostate Cancer Research, Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University of Alberta. All North American study samples will continue to be processed and analyzed in partnership with DynaLIFE Medical Labs in Edmonton, Alberta.

“We are excited to be recruiting patients again into our clinical study,” said John Lewis, CEO of Nanostics, “we are also happy to be able to add another US-based recruitment site that will further enrich the cohort diversity, and accelerate our recruitment timeline to ultimately reach our goal is to improve prostate cancer outcomes.”

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 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.

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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. For more information go to http://www.nanosticsdx.com.

For more information about this press release contact:

John D. Lewis,

CEO Nanostics, Inc.

Email: john.lewis@nanosticsdx.com

Phone: (780) 862-7445

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