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Mission

Solution

Team
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Rapid Urine Diagnostic Platform for Bladder Cancer

  • OncoreDox specializes in rapid, non-invasive urine-based testing, delivering accurate results at the point of care or in the home.
  • Bladder cancer is the most expensive cancer to manage, where 70% of patients relapse and will need lifelong monitoring cystoscopies 3-4 times per year.
  • Our innovative technology aims to redefine bladder cancer management through rapid, portable and accurate diagnosis and monitoring of bladder cancer patients.
  • The global bladder cancer diagnostics market is growing and projected to exceed $4.8 billion by 2030.

Our Mission

OncoreDox is dedicated to transforming bladder cancer care with a rapid urine-based diagnostic test using a patented 4-biomarker panel. Our diagnostic platform enables accurate, non-invasive detection and monitoring, reducing the number of painful cystoscopies.

Our Goals:

• Detect the most aggressive high-grade tumors early and reliably

• To improve patient outcomes and reduce cystoscopies healthcare burden

• Enable point of care and at-home diagnostics

• Increase access in high- and low-resource settings

From detection to lifelong monitoring, our mission is simple:
Give every bladder cancer patient and clinician the confidence of fast, painless, accurate answers.

70%

of bladder cancer patients experience recurrence1

bladder cancer survivors in the U.S. alone3

>740,000

Most expensive

cancer to manage per patient3

1. Mossanen M, Gore JL. The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol. 2014 Sep;24(5):487-91.
2. https://seer.cancer.gov/statfacts/html/urinb.html
3. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html

Our Solution

OncoreDox Logo

Rapid, Painless, and Accurate Urinary Diagnosis

Our platform leverages the sensitivity of electrochemical quantification with the specificity of proprietary monoclonal antibodies to deliver results in minutes. It pairs with a portable reader and companion app to guide recurrence monitoring and early detection.

Key Results:

Through mass spectrometry discovery and Western blot initial validation in 200 patients, we have identified 4 novel, patented urine biomarkers. These biomarkers demonstrated 100% sensitivity for high-grade tumors.

Today:

We are developing a multiplex lateral flow immunoassay (LFA) that delivers rapid, non-invasive results for bladder cancer recurrence monitoring at the point of care ensuring an easy entry into the market.

Tomorrow:

Our next-gen electrochemical platform designed to scale across the full spectrum of urologic oncology care:

• Higher sensitivity and real-time quantification

• Hematuria triage and population screening

• Expansion to prostate, kidney, and other urologic cancers

• Home use with digital connectivity for global scalability

Our Products

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Unlike cystoscopy and cytology, our platform offers a non-invasive and rapid solution with quantitative biomarker data.

The app provides real-time risk scores, tracks patient history, and supports clinical decision-making.

The USB-C reader delivers immediate results directly to the app, empowering both clinicians and patients.

Our test strips allow the quantification of four biomarkers in urine with high sensitivity and specificity.

Key Features

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Square-wave voltammetric for accurate quantification

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Rapid diagnosis using a single drop of urine

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Telehealth services and online monitoring

About Us

Welcome to OncoreDox, where we're redefining bladder cancer detection. Our multidisciplinary team of molecular scientists, physicians, and regulatory experts is committed to advancing non-invasive diagnostics. From lateral flow strips to a future electrochemical reader, we're building a platform for current and future urinary disease detection.

Team

Prof. Hadar Ben-Yoav

Co-Founder / Chief Technology Officer

Prof. Gal Markel

Co-Founder / Chief Executive Officer

Prof. Hadar Ben-Yoav

Chief Medical Officer

FAQs

Our test detects bladder cancer biomarkers in urine, especially for monitoring recurrence in patients with a prior diagnosis. Future clinical indications will include hematuria triaging and at-risk population screening (+55, smokers, chemical exposure).

A positive test suggests a possible recurrence or presence of a tumor. Your clinician may order follow-up investigations such as cystoscopy or imaging to confirm the diagnosis and guide treatment.

Initial validation of the biomarkers by mass-spectometry showed 100% sensitivity and 77–87% specificity for high-grade tumors depending on clinical background. These initial figures surpass currently used urine-based alternatives.

A positive test indicates a high-risk of recurrence or presence of a tumor. Your clinician may order follow-up investigations such as cystoscopy or imaging to confirm the diagnosis and guide treatment.

No, just a urine sample. No cystoscope. No catheter. No pain.

Our upcoming electrochemical platform will deliver immediate digital results through the companion app, offering faster turnaround and enhanced quantitative insights.

We recommend collecting a midstream sample from the first urine of the day. This ensures the highest concentration of biomarkers and reduces variability.

Two international clinical trials are underway across Canada, France, Germany, and Bangladesh, with a bridging trial in the U.S. planned. We are pursuing regulatory clearance through FDA 510(k) and CLIA waiver, followed by CE Mark, Health Canada authorization, and WHO pre‑qualification for broader global access.

We are pursuing a CLIA waiver for both point of care supervised by a health professional and at-home prescription use.

We provide comprehensive support for the integration of rapid diagnosis into existing healthcare workflows. Our team offers training, technical assistance, and necessary resources to ensure a smooth and efficient adoption of this innovative diagnostic technology.

We prioritize the security and privacy of patient data. Our systems adhere to industry-standard encryption protocols, and we comply with relevant data protection regulations, such as HIPAA (Health Insurance Portability and Accountability Act). All patient information is encrypted and handled with the utmost care and confidentiality.

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