Nanostics in the Media
Nanostics Launches ClarityDX Prostate Test in Alberta to Significantly Improve Prostate Cancer Screening
EDMONTON, ALBERTA – September 28 – Nanostics is thrilled to announce the availability of the ClarityDX Prostate test at its newly accredited clinical lab in Edmonton, Alberta. This innovative blood test marks a significant advancement in prostate cancer screening. It provides critical support to men, aged 40 to 75, and their physicians in making more informed decisions, with 3X the accuracy, about whether a biopsy is required following a high prostate-specific antigen (PSA) test result.
According to Dr. John D. Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology at the University of Alberta, “This test will reduce the number of unnecessary prostate biopsies, which are invasive, uncomfortable, and carry some risk.” Notably, research shows that adding ClarityDX Prostate to the patient care pathway could reduce unnecessary prostate biopsies by up to 35% and yield significant cost savings.
The global market for the prevention and treatment of prostate cancer exceeds $50 billion annually. Nanostics chose to develop and launch ClarityDX Prostate in Alberta due to the outstanding support and access to healthcare in the region. “We’re seeing tremendous growth in the Edmonton region’s life sciences sector. Nanostics’ prostate cancer diagnostic will revolutionize the detection of prostate cancer and significantly impact our region’s economy. It’s several big leaps forward all at once. Congratulations to the team at Nanostics,” says Malcolm Bruce, CEO, Edmonton Global.
The development and validation of ClarityDX Prostate has been made possible thanks to the invaluable support of the Alberta Prostate Cancer Research Initiative, the University of Alberta, and global research institutions. Additionally, generous donors have played a pivotal role in bringing this life-changing innovation to reality. Wendy Beauchesne, CEO of the Alberta Cancer Foundation, highlights the affinity donors have for supporting work like Nanostics. “We are dedicated to creating more moments for Albertans facing cancer and it’s a mission we share with Dr. Lewis and the Nanostics team. Through the launch of ClarityDX Prostate, we are enhancing detection and treatment options. It’s incredible to see what can happen when Albertans come together to support big ideas.”
Nanostics Clinical Lab Granted Provisional CPSA Accreditation
CPSA https://cpsa.ca/facilities-clinics/accreditation/
- With this provisional accreditation from the College of Physicians and Surgeons of Alberta (CPSA), Nanostics clinical laboratory in Edmonton can now begin providing its ClarityDX Prostate test to patients.
EDMONTON, AB, September 07, 2023 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, announced today that the College of Physicians and Surgeons of Alberta (CPSA) granted provisional accreditation to Nanostics Clinical Laboratory in Edmonton, Alberta, Canada. This important achievement means that Nanostics’ Clinical Laboratory, led by Medical Laboratory Director, Dr. Todd McMullen, can start providing the ClarityDX Prostate® test to patients.
“We are thrilled to receive CPSA accreditation because we can offer our test from our new clinical lab in Edmonton,” said John Lewis, CEO of Nanostics. “This is another major step towards ensuring men facing prostate cancer have access to the best tools that can aid them in managing this devastating disease.”
The ClarityDX Prostate test, validated in men from five clinical sites across Canada, the United States, and Czechia, is a simple and rapid test that accurately predicts the risk of having clinically significant prostate cancer. ClarityDX Prostate is intended to be used by men with elevated levels of PSA and is designed to help physicians and patients make a more informed decision on whether or not to proceed with a biopsy.
CPSA ensures the safety and quality of medical and diagnostic testing services in Alberta through an independent accreditation program. Any Alberta laboratory that performs and reports diagnostic tests to guide patient care needs to be CPSA accredited. It’s a rigorous assessment process based on Quality Management Systems, which are recognized by international healthcare external evaluation organizations.
“Nanostics’ has always been dedicated to exceptional operational standards with a strong commitment to quality performance” said Todd McMullen, Medical Laboratory Director of Nanostics. “CPSA accreditation highlights our commitment to quality and will provide patients with the confidence they need to trust our services.”
EV-Fingerprint test predicts aggressive prostate cancer
Clinical analysis of EV- Fingerprint to predict grade group 3 and above prostate cancer and avoid prostate biopsy
Adrian Fairey, Robert J. Paproski, Desmond Pink, Deborah L. Sosnowski, Catalina Vasquez, Bryan Donnelly, Eric Hyndman, Armen Aprikian, Adam Kinnaird, Perrin H. Beatty, John D. Lewis
Nanostics Announces New Medical Laboratory Director Todd McMullen
EDMONTON, AB, June 13, 2023 /CNW/ – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, announced today the appointment of Dr. Todd McMullen as the company’s new Medical Laboratory Director. In this role, Dr. McMullen will lead the accreditation and future operations of Nanostics’ new clinical laboratory in Edmonton, Alberta, Canada. Opening in the summer of 2023, Nanostics’ clinical laboratory will provide testing services to support the Canadian market.
Dr. McMullen received his M.D. from the University of Toronto and his Ph.D. in Biochemistry from the University of Alberta. Todd brings more than 25 years of academic research and medical directorship experience across multiple disease areas to Nanostics. He will support the strategy, direction, and execution of Nanostics’ clinical development programs and lead its medical affairs activities.
“We welcome Todd McMullen as Nanostics’ Medical Laboratory Director. Todd’s experience and insights will be invaluable as we launch our prostate cancer test, ClarityDX Prostate,” said John Lewis, CEO of Nanostics. “Prostate cancer remains one of the leading causes of cancer-related deaths in men, and we have shown that ClarityDX Prostate can improve patient care by more accurately identifying men with clinically significant prostate cancer.”
The appointment comes on the heels of exciting momentum for Nanostics as it readies for the launch of its ClarityDX Prostate® test to accurately detect clinically significant prostate cancer in men with elevated PSA levels. ClarityDX Prostate uses a proprietary algorithm that combines data from biological and clinical biomarkers to generate a risk score for clinically significant prostate cancer. The ClarityDX Prostate test is intended to be used by men with elevated levels of PSA and is designed to help physicians and patients make a more informed decision on whether or not to proceed with a biopsy.
Press Release: Nanostics Announces New Member of Board of Directors
Edmonton, Alberta – Nanostics Inc., a precision health diagnostics company, announced today the appointment of Aubrey Rankin to its Board of Directors. Mr. Rankin will join the board of directors at Nanostics replacing Mr. Reg Joseph as one of the independent directors for the company.
“We’re excited to announce Aubrey Rankin’s appointment to Nanostics’ Board of Directors. Aubrey’s vast experience and insights with patient-provider subscription platforms will be invaluable as we launch our lead prostate cancer diagnostic test, ClarityDX Prostate®,” said John Lewis, CEO of Nanostics.
Nanostics sends thanks to outgoing board member Reg Joseph, CEO of Health City, for his service. Reg’s insights into the Healthcare Industry were instrumental in helping Nanostics advance its lead diagnostic product, ClarityDX Prostate® through clinical studies and position it for regulatory approval.
News Release: Recognizing 10 years of philanthropic support for prostate cancer research
Two powerhouse researchers in prostate cancer will change the way we treat the disease, thanks to funding from legendary volunteer fundraisers, the Bird Dogs and the Alberta Cancer Foundation.
Working with the Alberta Cancer Foundation and the University of Alberta, the Bird Dogs have enabled a new one-term, five-year chair position to further prostate cancer research — the Bird Dogs Chair in Translational Oncology, a position to be held by researcher Dr. John Lewis. For the last 10 years, Dr. Lewis has held the Frank and Carla Sojonky Chair in Prostate Cancer Research, made possible by a $5 million endowment from the Bird Dogs. Taking over from Dr. Lewis in this position will be surgeon-scientist, Dr. Adam Kinnaird.
Press Release: Nanostics Receives CE Mark for its ClarityDX Prostate® Test to Detect Clinically Significant Prostate Cancer
- Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark.
- A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries.
- The ClarityDX Prostate® test provides patients and physicians with an accurate prediction of clinically significant prostate cancer to support decision-making and improve health outcomes for men suspected of having prostate cancer.
Press Release: Nanostics Announces the Launch of its Bladder Cancer Clinical Study Identifying Disease Predictors for Early Detection of Bladder Cancer
- Clinical study launched in June 2022 with patient recruitment in Alberta with plans to expand to further sites across North America.
- The aim of the study is to validate a novel and minimally invasive liquid biopsy test for bladder cancer diagnosis using Nanostics’ ClarityDX® diagnostic platform.
- The study is supported in part by the Alberta Innovates AICE-Concepts Program with a $600,000 award to Dr. John Lewis, Bird Dogs Chair in Translational Cancer Research at the University of Alberta.
Press Release: Nanostics Announces Study Data Supporting ClarityDX Prostate as a Reflex Test to Predict Clinically Significant Prostate Cancer
Real-world data shows that at a 94% sensitivity level for prostate cancer ClarityDX Prostate® is 147% more specific than the PSA test for predicting clinically significant prostate cancer. Using ClarityDX Prostate® as a reflex test vs. PSA test alone could have resulted in 37% fewer unnecessary biopsies.
Nanostics Re-Opens ClarityDX Prostate Clinical Study with New US Recruitment Site
PR: Nanostics announced 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. 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 featured on Alberta Impact Episode 5 with Bryce Lambert
1 of 7 Canadian men is diagnosed with prostate cancer each year. We cannot emphasize enough on how important it is to get tested each year. Nanostics has come up with a non-invasive diagnostic test to bring clarity to healthcare decisions. Their core technology is in development to be able to diagnose prostate cancer from a simple blood test.
Webinars / Technical Notes
CanPath Webinar with Dr. John Lewis
WEBINAR TO BE RESCHEDULED
Webinar: Predicting diseases through machine learning models
Date: Tuesday, November 22. 2022. New date TBD – please check back for updates.
Venue: Online – for more details and to register go to Event Link
Can Machine Learning models predict disease? Dr. John Lewis, Bird Dogs Chair in Translational Oncology at the University of Alberta, and CEO of Nanostics will talk about creating disease prediction models using CanPath questionnaire data, to help us understand the global risk factors of diseases like prostate cancer and how these risk factors differ for different populations.
Liquid biopsy EV analysis with small particle flow cytometry
Click here for CYTO 2022 POSTER PRESENTATION
Click here for CYTO 2022 SLIDE PRESENTATION
Small particle flow cytometry using 3 light scatter detectors enhances extracellular vesicle analysis in liquid biopsies, highlighting the potential to segregate EVs by refractive index
Pink, Desmond, Basu, Arghya, Valencia, Juliana, Pham, Diana, and Lewis, J.D.
Extracellular vesicle analysis using “small particle” flow cytometry would be greatly enhanced if data from materials of different refractive index (RI) could be segregated. Likewise, relative sizing of EVs using small particle flow cytometry is confounded by the influence of RI on light scatter. Beads of different composition and refractive index scatter light differently, so that small beads of high RI and large beads of lower RI can have overlapping signals on a two dimension light scatter plot. As particle size decreases, light scatter intensity profiles eventually merge regardless of refractive index. In this project, we aimed to demonstrate graphically, (1) the enhancement of EV flow analysis when using an additional angle of light scatter collection (medium angle of light scatter, MALS) to identify different sample components (e.g. lipids, protein, extracellular vesicles) and (2) the practical reality of sample component overlap at different particle sizes.
Nanostics CSO Desmond Pink will be presenting this work at CYTO 2022, June 3-7, in Philadelphia, US.
CYTO 2022 MOVING FORWARD
Empowering Scientists. Advancing Cytometry.
Antibody titration for flow cytometric analysis of Extracellular Vesicles: Are cell based protocols up to the task?
Date: 06/10/2021
Time: 10:00 am
Venue: Watch on Demand Now by clicking on the Address Button
Desmond Pink, CSO Nanostics
Why is ANTIBODY TITRATION critical to the success of any flow cytometry experiment?
In this webinar, Desmond Pink will investigate and report on antibody titration considerations for EVs, including sample concentration and processing, conjugate decisions, event triggering, platform differences, data processing and analysis, and real-world examples that highlight when antibody titration is necessary.
White Paper: Performance Qualification for MicroFlow Cytometers: Understanding technical limitations to improve your research
As microflow cytometry matures toward clinical applications for extracellular vesicle (EV) analysis, a concerted effort to improve reproducibility has begun. The new MISEV and MISEV MISEV-Flow guidelines are critical to enabling this reproducibility.
AUTHOR: DESMOND PINK, MICHAEL WONG, DIANA PHAM, RENJITH PILLAI, LEANNE STIFANYK, SYLVIA KOCH, REBECCA HIEBERT, OLIVER KENYON, AND JOHN LEWIS
Achievements
BioAlberta Recognizes Alberta Innovators and Entrepreneurs at 2018 Awards Gala
CALGARY, Alberta — At its 2018 awards gala, BioAlberta, the province’s life sciences industry association, recognized two leaders for their innovation and achievements. BioAlberta congratulates Circle Cardiovascular Imaging Inc. for winning its Company of the Year award and Dr. John Lewis for winning its Scientific Achievement and Innovation Award.
FALLING WALLS
Dr. John Lewis is the winner of the University of Alberta-TEC Edmonton Falling Walls Venture Competition which earned him entrance to the Falling Walls Finale Competition (the International Conference on Future Breakthroughs in Science and Society) which will be held in Berlin this November. Some travel expenses will be paid for.
