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ClarityDX Prostate Breakthrough Prostate Cancer Test

2024-01-10T22:02:48+00:00

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 Breakthrough Prostate Cancer Test2024-01-10T22:02:48+00:00

ClarityDX Prostate is Revolutionizing Prostate Cancer Detection

2024-01-10T22:05:14+00:00

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.

ClarityDX Prostate is Revolutionizing Prostate Cancer Detection2024-01-10T22:05:14+00:00

ClarityDX Prostate: A New Way to Detect Prostate Cancer

2023-11-02T17:36:00+00:00

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.

ClarityDX Prostate: A New Way to Detect Prostate Cancer2023-11-02T17:36:00+00:00

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

2024-01-10T22:12:10+00:00

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 Launches ClarityDX Prostate Test in Alberta to Significantly Improve Prostate Cancer Screening2024-01-10T22:12:10+00:00

Nanostics is Launching ClarityDX Prostate Test in Alberta on September 28

2023-09-28T20:52:33+00:00

Join us in person to help celebrate this exciting event!

Launch Day! The official launch of our ClarityDX Prostate test in Alberta! Join us to hear from invited speakers and help celebrate this exciting milestone!

When:                  Thursday, September 28th – 4:00 pm to 4:40 pm
Where:                 Edmonton Global – Telus House – Suite 2205, 10020 100 St NW
Host:                     Malcolm Bruce, CEO Edmonton Global
Emcee:                 Reg Joseph, CEO of Health Cities
Parking:               Available in the ATB building parkade.
RSVP:                   To media@nanosticsdx.com to attend.

Nanostics is Launching ClarityDX Prostate Test in Alberta on September 282023-09-28T20:52:33+00:00

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

CUA 2023

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

large banner

We’re heading to Montreal for #CUA2023! Go to our booth #60 to chat with Robert PaproskiDesmond PinkColin 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 20232023-06-23T02:17:41+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

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

2023-06-14T17:43:00+00:00

TECHNICAL NOTE

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.
Cytometry Part A: Antibody titrations are critical for microflow cytometric analysis of extracellular vesicles2023-06-14T17:43:00+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

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