Nanostics
Nanostics Precision Health is an Edmonton-based diagnostic company that develops and commercializes ClarityDX Prostate, an AI-driven blood test that generates risk scores for aggressive prostate cancer to help patients and clinicians decide whether a biopsy is needed. The company sells the test directly to consumers across six Canadian provinces and through healthcare system partners, and is pursuing FDA approval for US market entry.
- Company typePrivate
- Founded2017
- HeadquartersEdmonton, Canada
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Nanostics does
Nanostics Inc. (operating as Nanostics Precision Health) is a privately held Canadian diagnostic company headquartered in Edmonton, Alberta, that develops and commercializes the ClarityDX platform — an AI-driven blood-based diagnostic system for prostate cancer risk assessment. Its flagship product, ClarityDX Prostate, analyzes standard clinical inputs (age, total PSA, free PSA ratio, prostate volume, PI-RADS score, prior negative biopsy status, and DRE findings) through proprietary machine learning models to generate a risk score for aggressive prostate cancer (Grade Group ≥3). The platform offers four model variants (base, +DRE, +MRI, +DRE+MRI) that have demonstrated AUCs of 0.81–0.88 across multi-institutional validation and can reduce unnecessary biopsies by 47% while maintaining detection of over 94% of aggressive cancers. A complementary EV-Fingerprint test, which uses extracellular vesicle biomarkers analyzed via microflow cytometry combined with machine learning, is also in the company's pipeline.
Nanostics commercializes ClarityDX Prostate through a dual go-to-market approach: a direct-to-consumer e-commerce channel with provincial pricing ($300 CAD in Alberta, $500 CAD in British Columbia, undisclosed elsewhere), plus enterprise healthcare system partnerships anchored by a clinical laboratory relationship with Alberta Precision Laboratory. The test is currently available in six Canadian provinces (Alberta, British Columbia, Ontario, Quebec, Saskatchewan, and Yukon) and the company is pursuing FDA approval to enter the US market. The business is supported by grant and equity funding from Genome Canada, Genome Alberta, the University of Alberta Innovation Fund, NRC-IRAP, Alberta Innovates, Prostate Cancer Canada, Ride for Dad, and other regional partners, with the most recent disclosed round being a $2.79M Canadian Biotechnology Innovation and Commercialization Initiative round in June 2025.
The company operates with a small team of 1–10 employees led by CEO and founder Dr. John Lewis (Bird Dogs Chair of Translational Oncology at the University of Alberta), Co-Founder and COO Catalina Vasquez, CTO and Co-Founder Robert Paproski, CCO Colin Coros, and CSO Desmond Pink. The company originated from academic research at the University of Alberta and underwent a strategic pivot from its original nanotechnology focus to a machine learning diagnostic platform. Revenue is not publicly disclosed and the company remains in early commercialization, with growth signals concentrated in geographic expansion (FDA pathway), product extensions (EV-Fingerprint), and accumulating peer-reviewed scientific validation.
Nanostics firmographics
Firmographics- Name
- Nanostics
- Legal name
- Nanostics Inc.
- Website
- https://nanosticsdx.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Nanostics Precision Health is an Edmonton-based diagnostic company that develops and commercializes ClarityDX Prostate, an AI-driven blood test that generates risk scores for aggressive prostate cancer to help patients and clinicians decide whether a biopsy is needed. The company sells the test directly to consumers across six Canadian provinces and through healthcare system partners, and is pursuing FDA approval for US market entry.
- Ownership category
- akta.pro rank
Nanostics industry classification
Industry- Product category
- Cancer Diagnostics
- NAICS
- Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
- akta.pro secondary industries
- Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Proteomics & Biomarker Analytical Testing (HLAGADAG), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where Nanostics is headquartered
LocationHeadquarters
- HQ city
- Edmonton
- HQ country
- Canada
- HQ region
- North America
Offices2 records
Markets served
Nanostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Operations, Personnel, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Test Sales: Revenue generated from direct sales of ClarityDX Prostate test to consumers and healthcare providers. Test is available for ordering online with pricing varying by province in Canada.
- Healthcare System Partnerships: Revenue potential through reimbursement agreements with provincial healthcare systems and adoption into clinical workflows.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - Alberta |
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - British Columbia |
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - Ontario |
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - Quebec |
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - Saskatchewan |
| Unit Pricing | Pay-as-you-go | ClarityDX Prostate Test - Yukon |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels7 records
Nanostics product offering
Product offeringCore offering
Nanostics develops and sells ClarityDX Prostate, a blood-based diagnostic test that uses proprietary machine learning algorithms to generate a risk score for aggressive prostate cancer (Grade Group ≥3) from standard clinical inputs (age, PSA, free PSA ratio, DRE, MRI findings) and blood-based biomarkers. The test is offered in four model variants (base, +DRE, +MRI, +DRE+MRI) and is processed at Nanostics' accredited clinical laboratory in Edmonton, with results used by urologists and primary care physicians to inform prostate biopsy decisions and reduce unnecessary invasive procedures.
Product overview
Nanostics offers the ClarityDX platform, an AI-powered diagnostic system for prostate cancer risk assessment. The core product is ClarityDX Prostate, a blood-based test that analyzes clinical features and blood-based biomarkers using machine learning to generate risk scores for aggressive prostate cancer. The platform offers four model variants: the base ClarityDX Prostate model, plus optional modules for Digital Rectal Exam (DRE) data and/or MRI data. Regional variants are available across Canadian provinces (Alberta, British Columbia, Ontario, Quebec, Saskatchewan, Yukon) with varying pricing. The test is designed as an adjunctive tool for men with elevated PSA results to help determine whether a prostate biopsy is necessary.
Differentiator
Problem solved
Functional benefit
Brands
- ClarityDX: AI-powered diagnostic platform that analyzes clinical data to provide actionable decision support for next-step testing, applicable to a wide range of cancers and other diseases.
- ClarityDX Prostate
Products and services
- ClarityDX Prostate A blood-based diagnostic test that uses machine learning to analyze clinical features (age, total PSA, free PSA ratio, prostate volume from MRI, PI-RADS, prior negative biopsy status, DRE findings) and blood-based biomarkers to generate a calibrated risk score for aggressive prostate cancer (Grade Group ≥3). Designed as an adjunctive test for men with elevated PSA results to help determine whether a prostate biopsy is necessary; processed at Nanostics' accredited clinical laboratory in Edmonton. Achieves AUC of 0.81 in base form, with reductions of unnecessary biopsies by up to 47% while detecting over 94% of aggressive cancers.
- ClarityDX Prostate +DRE Extended ClarityDX Prostate model variant incorporating Digital Rectal Exam (DRE) data in addition to clinical features and blood biomarkers to predict aggressive prostate cancer. Achieves AUC of 0.82 in multi-institutional validation across six institutions in Canada, the United States, and Europe.
- ClarityDX Prostate +MRI Extended ClarityDX Prostate model variant incorporating MRI data (prostate volume and PI-RADS score) in addition to clinical features and blood biomarkers to predict aggressive prostate cancer. Achieves AUC of 0.87 without DRE and 0.88 with DRE in multi-institutional validation across six institutions in Canada, the United States, and Europe.
- ClarityDX Prostate +DRE +MRI Extended ClarityDX Prostate model variant incorporating both Digital Rectal Exam (DRE) and MRI data (prostate volume, PI-RADS score) in addition to clinical features and blood biomarkers to predict aggressive prostate cancer. The combined-input configuration reaches the highest AUC in the published multi-institutional validation across six institutions in Canada, the United States, and Europe.
Quantifiable outcome
- Reduces unnecessary biopsies by 47% while maintaining detection of over 94% of aggressive cancers
- +4 more outcomes
Companies that use Nanostics
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles3 records
Nanostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature4 records
Nanostics partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core and minor.
- UCLA (University of California, Los Angeles)coreClinical site for multi-institutional validation study of ClarityDX Prostate models. Provided patient data and clinical expertise for model development and validation.
- Johns Hopkins UniversitycoreClinical site for multi-institutional validation study contributing patient cohorts and clinical data for model validation across six institutions.
- University of CalgarycoreClinical site for multi-institutional validation study contributing patient data and urological expertise.
- Thomayer University HospitalcoreClinical site in Prague, Czech Republic for multi-institutional validation study, providing diverse patient population for model validation.
- Chesapeake UrologycoreClinical site for multi-institutional validation study contributing patient data from urology practice.
- Alberta Precision LaboratorycoreClinical laboratory partner shown in company partnerships section, involved in processing ClarityDX Prostate tests in Alberta.
- Applied Pharmaceutical Innovation (API)minorPartner organization supporting pharmaceutical innovation ecosystem in Alberta.
- Scale Good FundminorImpact fund supporting innovation and entrepreneurship in Edmonton/Alberta region.
- Edmonton UnlimitedminorEdmonton-based innovation ecosystem partner supporting startups and technology companies.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Nanostics competitors and assessment
Company assessmentDirect peers
- MDxHealth: MDxHealth's SelectMDx is a urine-based molecular test that helps determine the risk of clinically significant prostate cancer prior to biopsy — directly competing with ClarityDX Prostate in the same urology decision-support workflow.
- OPKO Health: OPKO markets the 4Kscore test, a blood-based prostate cancer risk assessment that, like ClarityDX Prostate, aims to reduce unnecessary biopsies by stratifying risk of aggressive disease in men with elevated PSA.
- Veracyte: Veracyte's Decipher Prostate Genomic Classifier is a tissue-based genomic test for risk stratification in prostate cancer, addressing the same biopsy/treatment decision points that ClarityDX Prostate targets upstream of biopsy.
Broad incumbents
- Exact Sciences: Exact Sciences is a major oncology diagnostics company (Cologuard, Oncotype DX) with the commercial scale, payer relationships, and sales infrastructure that Nanostics would need to compete with at scale in cancer screening.
- Guardant Health: Guardant Health is a leading liquid biopsy company (Guardant360, Reveal) whose oncology liquid biopsy franchise overlaps with Nanostics' blood-based biomarker approach and represents a potential competitor or acquirer for adjacent indications.
- Natera: Natera operates Signatera (MRD) and Prospera (transplant) blood-based tests using cfDNA analysis — overlapping with Nanostics in blood-based oncology diagnostics and representing a comparable commercial-stage molecular diagnostics peer.
- Grail: Grail's Galleri multi-cancer early detection test and emerging single-cancer products compete for the same blood-based cancer screening thesis and payer attention that Nanostics targets in prostate cancer.
- Philips: Philips is a major prostate MRI/imaging vendor whose prostate imaging pathway (PI-RADS, MRI fusion biopsy) is the dominant alternative to blood-based adjuncts like ClarityDX Prostate, especially in higher-resource urology practices.
- Hologic: Hologic is a diversified women's health and diagnostics company with a large commercial sales force into urology and primary care — the same channel Nanostics is targeting — and represents a potential strategic acquirer or distribution partner.
Others
- Bio-Techne: Bio-Techne supplies proteomic biomarker assays and analytical tools used by diagnostics developers and academic prostate cancer labs, positioning it as an enabling tool/infrastructure provider adjacent to Nanostics' biomarker workflow.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights6 records
Customer concentration
Nanostics social profiles
Digital presenceNanostics compliance and trust
Trust signalCompliance2 records
Nanostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Nanostics leadership team
Management profileNumber of profiles
Profiles5 records
Nanostics funding detail
Funding detailFunding overview
Funding rounds4 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Nanostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Nanostics
What does Nanostics do?
Nanostics develops and sells ClarityDX Prostate, a blood-based diagnostic test that uses proprietary machine learning algorithms to generate a risk score for aggressive prostate cancer (Grade Group ≥3) from standard clinical inputs (age, PSA, free PSA ratio, DRE, MRI findings) and blood-based biomarkers. The test is offered in four model variants (base, +DRE, +MRI, +DRE+MRI) and is processed at Nanostics' accredited clinical laboratory in Edmonton, with results used by urologists and primary care physicians to inform prostate biopsy decisions and reduce unnecessary invasive procedures.
Is Nanostics a public or private company?
Nanostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Nanostics founded?
Nanostics was founded in 2017. It employs 1 to 10 people.
Where is Nanostics based?
Nanostics is headquartered in Edmonton, Canada, in the North America region.
How does Nanostics make money?
Two revenue lines are on record. Diagnostic Test Sales are the primary driver. The others are healthcare System Partnerships.
Who are Nanostics's main competitors?
Direct peers on record are MDxHealth, OPKO Health and Veracyte. Broad incumbents are Exact Sciences, Guardant Health, Natera, Grail, Philips and Hologic. Bio-Techne is listed as an others.
Does Nanostics have an API?
No public API is recorded for Nanostics.
What industry is Nanostics in?
Nanostics's product category is Cancer Diagnostics. Its primary akta.pro industry code is HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy), with a secondary code of HLAAAMAH, Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes). Its NAICS code is 621511 and its SIC code is 2835.