Media

Media2024-05-07T22:53:19+00:00

Brochures and Media

Research supporting ClarityDX Prostate published in Nature Digital Medicine

June 26th, 2024|Article, Publication|

Published 26 June 2024

Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform

M. Eric Hyndman, Robert J. Paproski, Adam Kinnaird, Adrian Fairey, Leonard Marks, Christian P. Pavlovich, Sean A. Fletcher, Roman Zachoval, Vanda Adamcova, Jiri Stejskal, Armen Aprikian, Christopher J. D. Wallis, Desmond Pink, Catalina Vasquez, Perrin H. Beatty & John D. Lewis

Abstract
The current prostate cancer (PCa) screen test, prostate-specific antigen (PSA), has a high sensitivity for PCa but low specificity for high-risk, clinically significant PCa (csPCa), resulting in overdiagnosis and overtreatment of non-csPCa. Early identification of csPCa while avoiding unnecessary biopsies in men with non-csPCa is challenging. We built an optimized machine learning platform (ClarityDX) and showed its utility in generating models predicting csPCa. Integrating the ClarityDX platform with blood-based biomarkers for clinically significant PCa and clinical biomarker data from a 3448-patient cohort, we developed a test to stratify patients’ risk of csPCa; called ClarityDX Prostate. When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive value, and 91% negative predictive value, at a ≥ 25% threshold. Using ClarityDX Prostate at this threshold could avoid up to 35% of unnecessary prostate biopsies. ClarityDX Prostate showed higher accuracy for predicting the risk of csPCa than PSA alone and the tested model-based risk calculators. Using this test as a reflex test in men with elevated PSA levels may help patients and their healthcare providers decide if a prostate biopsy is necessary.

Nanostics Prostate Cancer Screening Test, ClarityDX Prostate®, becomes accessible to men in British Columbia, Saskatchewan, and Ontario

June 5th, 2024|Article, Press Release|

EDMONTON, ABJune 5, 2024 /CNW/ – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, is thrilled to announce today that men can now provide blood samples for its ClarityDX Prostate test at LifeLabs collection sites across British ColumbiaSaskatchewan, and Ontario.

ClarityDX Prostate uses biological data, clinical information, and machine learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening. It provides critical support to men and their healthcare providers in making more informed decisions about whether to proceed with a biopsy or not following a high prostate-specific antigen (PSA) test result.

“We are very happy that we can now bring a powerful tool in prostate cancer screening to men and their healthcare providers in BC, Saskatchewan, and Ontario“, said Dr. John Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology at the University of Alberta. “When a doctor orders this test for their patient, they will receive accurate information about his risk of aggressive prostate cancer, helping make informed treatment decisions and avoid unnecessary invasive prostate biopsies.”

ClarityDX Prostate is available in British ColumbiaSaskatchewan, and Ontario as a laboratory-developed test from Nanostics Clinical Laboratory in Edmonton, Alberta. In these provinces, tests are ordered, analyzed, and reported to the prescribing healthcare provider by Nanostics.

Go to www.nanosticsdx.com for more information and to order ClarityDX Prostate. Please direct all inquiries about the ClarityDX Prostate test to Nanostics via email at info@nanosticsdx.com or telephone 1-800-672-2027. ClarityDX Prostate is also available in Alberta from Nanostics as well as in Quebec from CDL Laboratories.

Click on the link below to read the full press release.

Nanostics partners with CDL Laboratories to Provide Access to ClarityDX Prostate for Men at Risk of Having Aggressive Prostate Cancer

May 22nd, 2024|Article, Press Release|

  • Quebec-based CDL Laboratories will now offer the validated ClarityDX Prostate risk score to healthcare providers and their patients suspected of having aggressive prostate cancer.
  • ClarityDX Prostate combines biological and clinical information using AI-powered learning to generate a risk score for aggressive prostate cancer.

EDMONTON, ALBERTA – May 22 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, signed an agreement with Quebec-based CDL Laboratories (CDL) to expand access to the ClarityDX Prostate® to men and their healthcare providers.

ClarityDX Prostate uses biological data, clinical information, and AI-powered learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening. It provides critical support to men and their healthcare providers in making more informed decisions about whether to proceed with a biopsy or not following a high prostate-specific antigen (PSA) test result.

Click on the link below to read the full press release.

Nanostics Receives Funding from the University of Alberta Innovation Fund to Propel Adoption of the ClarityDX Prostate Test

April 23rd, 2024|Article, Press Release|

  • University of Alberta Innovation Fund invests in Nanostics to support adoption of its ClarityDX Prostate test
  • ClarityDX Prostate is a blood test that combines biological and clinical information using machine learning to generate a risk score for aggressive prostate cancer

EDMONTON, ALBERTA – April 23 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, announced today that it received an investment from the University of Alberta Innovation Fund (UAIF) to help propel adoption of Nanostics’ ClarityDX Prostate® test in North America.

Funds raised through the UAIF will go towards expanding access to ClarityDX Prostate across North America and supporting the expansion of its product pipeline, including the development of ClarityDX Bladder, a minimally invasive bladder cancer diagnostic test.

ClarityDX Prostate is currently available in Canada as a laboratory-developed test. For more information or to order the test please visit nanosticsdx.com.

Click below to read the full press release.

Nanostics and Alberta Health Services collaborate to develop new diagnostic tools for urological diseases

April 9th, 2024|Article, Press Release|

  • Nanostics and Alberta Health Services (AHS) agreement enables collaboration with AHS data scientists to develop new tools to improve the diagnosis of urological diseases.
  • This collaboration will leverage Alberta’s comprehensive digital healthcare assets to improve patient care while satisfying all AHS privacy concerns.

EDMONTON, ALBERTA – April 9th – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, is excited to announce a partnership with Cancer Care Alberta, Alberta Health Services (AHS) to leverage advanced data analytics from Connect Care and the Cancer Care Alberta Data Environment for Cancer Inquiries and Decisions (DECIDe). This agreement will streamline access to Connect Care’s powerful and consolidated “one record, one patient, one health clinical information system” to help drive diagnostic and prognostic innovations in urological care in Alberta.

Click below to read the full press release.

ClarityDX Prostate Breakthrough Prostate Cancer Test

January 10th, 2024|Article, Video|

ClarityDX Prostate is a breakthrough test that significantly advances prostate cancer screening. It provides critical support to men and their primary care providers in making more informed decisions, with 3X the accuracy, about whether a biopsy is required following a high prostate-specific antigen (PSA) test result.

ClarityDX Prostate is Revolutionizing Prostate Cancer Detection

January 10th, 2024|Article|

Disruption Magazine Special Issue 21

A Better Way: How Nanostics is Revolutionizing Prostate Cancer Detection

“Any jurisdiction in the world can adopt our test. It’s got huge potential.” Nanostics Chief Commercialization Officer Colin Coros

In the realm of medical innovation, success stories often find their roots in personal journeys. Such is the case with Nanostics, a pioneering company in the field of prostate cancer diagnostics. The tale begins with Frank Sojonky, an Alberta businessman, who, upon facing a prostate cancer diagnosis, embarked on a mission to revolutionize the landscape of prostate cancer research and testing.

Sojonky’s dissatisfaction with the lack of focus on prostate cancer research in Alberta led to the creation of the Bird Dogs for Prostate Cancer Research organization in partnership with the Alberta Cancer Foundation. The organization ultimately raised more than $20 million to establish a translational research program, known as the Alberta Prostate Cancer Research Initiative, headed by CEO Dr. John Lewis. It evolved into the world’s largest repository for prostate cancer patient samples, and with a focus on translation, those samples became instrumental in developing new therapeutics and diagnostic tests.

Click below to read the full article.

Nanostics Launches ClarityDX Prostate Test in Alberta to Significantly Improve Prostate Cancer Screening

September 28th, 2023|Article, Press Release|

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.

Click below to read the full press release.

Nanostics Clinical Lab Granted Provisional CPSA Accreditation

September 7th, 2023|Article, Press Release|

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

June 23rd, 2023|Article, Publication|

Published 17 June 2023

Clinical analysis of EV- Fingerprint to predict grade group 3 and above prostate cancer and avoid prostate biopsy

Adrian FaireyRobert J. PaproskiDesmond PinkDeborah L. SosnowskiCatalina VasquezBryan DonnellyEric HyndmanArmen AprikianAdam KinnairdPerrin H. BeattyJohn D. Lewis

Abstract
There is an unmet clinical need for minimally invasive diagnostic tests to improve the detection of grade group (GG) ≥3 prostate cancer relative to prostate antigen-specific risk calculators. We determined the accuracy of the blood-based extracellular vesicle (EV) biomarker assay (EV Fingerprint test) at the point of a prostate biopsy decision to predict GG ≥3 from GG ≤2 and avoid unnecessary biopsies.
This study analyzed 415 men referred to urology clinics and scheduled for a prostate biopsy, were recruited to the APCaRI 01 prospective cohort study. The EV machine learning analysis platform was used to generate predictive EV models from microflow data. Logistic regression was then used to analyze the combined EV models and patient clinical data and generate the patients’ risk score for GG ≥3 prostate cancer.
The EV-Fingerprint test was evaluated using the area under the curve (AUC) in discrimination of GG ≥3 from GG ≤2 and benign disease on initial biopsy. EV-Fingerprint identified GG ≥3 cancer patients with high accuracy (0.81 AUC) at 95% sensitivity and 97% negative predictive value. Using a 7.85% probability cutoff, 95% of men with GG ≥3 would have been recommended a biopsy while avoiding 144 unnecessary biopsies (35%) and missing four GG ≥3 cancers (5%). Conversely, a 5% cutoff would have avoided 31 unnecessary biopsies (7%), missing no GG ≥3 cancers (0%).
EV-Fingerprint accurately predicted GG ≥3 prostate cancer and would have significantly reduced unnecessary prostate biopsies.

Nanostics Announces New Medical Laboratory Director Todd McMullen

June 13th, 2023|Article, Press Release|

EDMONTON, ABJune 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

November 17th, 2022|Article|

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

October 13th, 2022|Article, Press Release|

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

August 23rd, 2022|Article|

  • 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

July 20th, 2022|Article|

  • 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

June 30th, 2022|Article|

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

June 16th, 2020|Article|

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.

Webinars / Technical Notes

ClarityDX Prostate: A New Way to Detect Prostate Cancer

November 2nd, 2023|Webinar|

On November 1, 2023, CEO John Lewis presented a webinar for Prostate Cancer Foundation Canada called “ClarityDX Prostate: A New Way to Detect Prostate Cancer.”  Click on the Webinar button below to watch it!  Go to PCFC’s website here to check out the rest of their video library.

ClarityDX Prostate is an innovative blood test that 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.

November 3rd, 2022|Event, Webinar|

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

June 4th, 2022|Event, White Paper|

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?

October 6th, 2021|Webinar|

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

July 6th, 2020|White Paper|

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

Best Startup Workplace of the Year

May 7th, 2024|Achievement|

Nanostics is thrilled to announce that we’ve been awarded Best Startup Workplace of the Year in the 2024 YEG Startup Community Awards! We extend heartfelt congratulations to all the nominees. We also express our gratitude to the YEG Startup Community volunteers for their organization of this exceptional event.

This achievement speaks volumes about the incredible culture created by our team of dedicated employees. Their hard work, dedication, and commitment to excellence have truly set us apart. We are immensely grateful for their contributions in making Nanostics a truly exceptional workplace. Thank you to each and every member of our team for your unwavering efforts. Together, we continue to drive innovation forward!

YEG Startup Awards 2024

BioAlberta Recognizes Alberta Innovators and Entrepreneurs at 2018 Awards Gala

September 24th, 2018|Achievement|

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

August 29th, 2018|Achievement|

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.

Go to Top