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Nanostics Clinical Lab Granted Provisional CPSA Accreditation

2023-09-18T16:18:46+00:00

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.”

Nanostics Clinical Lab Granted Provisional CPSA Accreditation2023-09-18T16:18:46+00:00

EV-Fingerprint test predicts aggressive prostate cancer

2023-09-02T22:04:14+00:00
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.
EV-Fingerprint test predicts aggressive prostate cancer2023-09-02T22:04:14+00:00

Nanostics Announces New Medical Laboratory Director Todd McMullen

2023-06-13T13:30:24+00:00

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.

Nanostics Announces New Medical Laboratory Director Todd McMullen2023-06-13T13:30:24+00:00

Press Release: Nanostics Announces New Member of Board of Directors

2022-11-17T14:38:46+00:00

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.

Press Release: Nanostics Announces New Member of Board of Directors2022-11-17T14:38:46+00:00

News Release: Recognizing 10 years of philanthropic support for prostate cancer research

2022-10-13T05:02:22+00:00

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.

News Release: Recognizing 10 years of philanthropic support for prostate cancer research2022-10-13T05:02:22+00:00

Press Release: Nanostics Receives CE Mark for its ClarityDX Prostate® Test to Detect Clinically Significant Prostate Cancer

2022-08-23T12:18:30+00:00
  • 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 Receives CE Mark for its ClarityDX Prostate® Test to Detect Clinically Significant Prostate Cancer2022-08-23T12:18:30+00:00

Press Release: Nanostics Announces the Launch of its Bladder Cancer Clinical Study Identifying Disease Predictors for Early Detection of Bladder Cancer

2022-07-20T13:09:06+00:00
  • 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 the Launch of its Bladder Cancer Clinical Study Identifying Disease Predictors for Early Detection of Bladder Cancer2022-07-20T13:09:06+00:00

Press Release: Nanostics Announces Study Data Supporting ClarityDX Prostate as a Reflex Test to Predict Clinically Significant Prostate Cancer

2022-06-30T12:14:03+00:00

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.

Press Release: Nanostics Announces Study Data Supporting ClarityDX Prostate as a Reflex Test to Predict Clinically Significant Prostate Cancer2022-06-30T12:14:03+00:00

Nanostics Re-Opens ClarityDX Prostate Clinical Study with New US Recruitment Site

2022-01-04T19:06:51+00:00

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 Re-Opens ClarityDX Prostate Clinical Study with New US Recruitment Site2022-01-04T19:06:51+00:00
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