Author: perrin - Page 2 - Nanostics Precision Health

Nanostics Clinical Lab Granted Provisional CPSA Accreditation

perrin2023-09-18T16:18:46+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.”

Press Release

Nanostics Clinical Lab Granted Provisional CPSA Accreditationperrin2023-09-18T16:18:46+00:00

CUA 2023

perrin2023-06-23T02:17:41+00:00

We’re heading to Montreal for #CUA2023! Go to our booth #60 to chat with Robert Paproski, Desmond Pink, Colin Coros, and Catalina Vasquez about ClarityDX Prostate, a risk score to predict aggressive prostate cancer.
Dr. Adam Kinnaird will be moderating an e-poster, “Clinical validation of optimized neural network risk models to predict grade group 2 and above prostate cancer and avoid unneeded biopsies”.

Go here to view the poster and post questions, CUA 2023 e-Poster.

Session 9 Oncology (Prostate – Part 2)
Room: Joyce (Level A), 2023-06-25 at 7:35:00
#diagnostics #prostatecancer #machinelearningalgorithms

CUA 2023perrin2023-06-23T02:17:41+00:00

EV-Fingerprint test predicts aggressive prostate cancer

perrin2023-09-02T22:04:14+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 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

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.

Full Article

EV-Fingerprint test predicts aggressive prostate cancerperrin2023-09-02T22:04:14+00:00

Cytometry Part A: Antibody titrations are critical for microflow cytometric analysis of extracellular vesicles

perrin2023-06-14T17:43:00+00:00

TECHNICAL NOTE

Desmond Pink, Arghya Basu, Michael Wong, Diana Pham, Juliana Valencia, Vivian Triana, Perrin H. Beatty, Aja M. Rieger, John D. Lewis

Optimization of flow cytometry assays for extracellular vesicles (EVs) often fail to include appropriate reagent titrations – the most critically antibody titration is either not performed or is incomplete. Using nonoptimal antibody concentration is one of the main sources of error leading to a lack of reproducible data. Antibody titration for the analysis of antigens on the surface of EVs is challenging for a variety of technical reasons. Using platelets as surrogates for cells and platelet-derived particles as surrogates for EV populations, we demonstrate our process for antibody titration, highlighting some of the key analysis parameters that may confound and surprise new researchers moving into the field of EV research. Additional care must be exercised to ensure instrument and reagent controls are utilized appropriately. Complete graphical analysis of positive and negative signal intensities, concentration, and separation or stain index data is highly beneficial when paired with visual analysis of the cytometry data. Using analytical flow cytometry procedures optimized for cells for EV analysis can lead to misleading and nonreproducible results.

Full Article

Cytometry Part A: Antibody titrations are critical for microflow cytometric analysis of extracellular vesiclesperrin2023-06-14T17:43:00+00:00

Nanostics Announces New Medical Laboratory Director Todd McMullen

perrin2023-06-13T13:30:24+00:00

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 Medical Laboratory Director Todd McMullenperrin2023-06-13T13:30:24+00:00

Canadian Women’s Network Pathway to Silicon Valley Week

perrin2023-04-18T20:06:51+00:00

Date: April 17-20
Venue: Silicon Valley

Canadian Women's Network Pathway to Silicon Valley Week

Our COO Catalina Vasquez is attending the Canadian Women’s Network pathway for Silicon Valley, now! For the next 4 days, she’s networking, learning, and building industry connections with investors, plus fellow executives and founders in Silicon Valley. For more info about this program click on the title above.

Canadian Women’s Network Pathway to Silicon Valley Weekperrin2023-04-18T20:06:51+00:00

38th Annual EAU Congress

perrin2023-03-04T01:38:20+00:00

Date: March 10-13
Venue: In-person, Allianz MiCo, Milano Convention Centre, Milan, Italy

EAU23 is only 1 week away! This is a must-go-to international event dedicated to urology – are you going? Over 4500 abstracts were submitted for EAU23, the third-highest number ever recorded for an Annual EAU Congress.

Hot topics this year include:
Prostate cancer screening and early detection (including imaging), transplant surgery, infections, stones, and major cancers.
Personalized medicine in diagnostics and treatment.
Prostate cancer genomics for practitioners
Men’s health and BPH treatment.
‘Best of EAU’ sessions will be summarised at the end of the congress

SESSION 04

ABSTRACT 0061

38th Annual EAU Congressperrin2023-03-04T01:38:20+00:00

4th Annual AIMSSxGairdner AIHC

perrin2023-03-04T00:12:19+00:00

4th Annual AIMSSxGairdner AI Healthcare Conference

Date: March 10-12
Venue: In-person, and virtual, The Matrix Hotel, Edmonton, Alberta

The AIMSSxGairdner AI-healthcare conference is coming up soon -March 10-12! Make sure to grab your free tickets: bit.ly/4139b6p

CTO Robert Paproski will take part in a panel discussion about AI in the healthcare industry, plus we will have a booth display so come by and say hello!

Nanostics is proud to be a silver-tier sponsor of this event.
#ClarityDX_Prostate #urology #prostatecancer #diagnostics #precisionmedicine

4th Annual AIMSSxGairdner AIHCperrin2023-03-04T00:12:19+00:00

PUA 2023

perrin2023-03-04T00:02:03+00:00

68th Prairie Urological Association Annual Meeting – PUA 2023

Date: March 03-05
Venue: In-person, Lake Louise, Alberta

COO Catalina Vasquez and CCO Colin Coros are in beautiful Lake Louise for the PUA conference

Catalina Vasquez is presenting ClarityDX Prostate: an accurate way to detect clinically significant prostate cancer.

We are proud to be a scientific program session sponsor for this event.
Please reach out to us by DM to chat about our ClarityDX Prostate test.
#ClarityDX_Prostate #urology #prostatecancer #diagnostics #precisionmedicine

PUA 2023perrin2023-03-04T00:02:03+00:00

Molecular Oncology: Building predictive disease models using extracellular vesicle microscale flow cytometry and machine learning

perrin2023-01-09T20:17:59+00:00

We developed the extracellular vesicle machine learning analysis platform (EVMAP) to improve the prediction of diseases such as cancer. The platform combines extracellular vesicle analysis using microscale cytometry with a machine learning approach to generate predictive models. In this work, we utilized EVMAP to generate a blood test to predict high-grade prostate cancer in men that was significantly more accurate than the prostate-specific antigen test. This platform could be applied to many different diseases.

Full Article

Molecular Oncology: Building predictive disease models using extracellular vesicle microscale flow cytometry and machine learningperrin2023-01-09T20:17:59+00:00

About perrin

Title

Follow Us

Contact Us