Early Detection of Urothelial Carcinoma (UC)
UriFind is an non-invasive methylation biomarker test that detects urothelial carcinoma, covering nearly all cases of bladder cancer.
CLIA-Certified Lab Service
Introducing UriFind® Test
As an early detection test for bladder cancer, UriFind’s key advantage is its ability to identify low-grade and Ta-stage tumors. These cancers are in early stages, and early detection offers patients a broader range of treatment options.
Sensitivity
Highly sensitive (93%) for early-stage cancer detection, outperforming urine cytology (67%) and FISH (73%).
Prediction
Predicts cancer risk in hematuria patients and those needing cystoscopy.
Specificity
No interference from UTIs or other genitourinary conditions.
Convenience
UriFind™ does not require fresh urine to preserve cell integrity, while urine cytology and UroVysion do, enabling sample collection at distant locations.
What is the intended use of UriFind Urothelial Carcinoma Test?
UriFind® Urothelial Carcinoma Test has FDA Breakthrough Device Designation and is validated as a Laboratory Developed Test (LDT) for lower and upper urinary tract cancers.
The UriFind Urothelial Carcinoma Test offers non-invasive support in diagnosing patients suspected of having urothelial carcinoma who may require further clinical evaluation due to symptoms such as:
Hematuria (blood in urine)
Bladder irritation
Bladder abnormalities detected through imaging
However, it should not be solely relied upon for diagnosing tumors or confirming suspected bladder cancer.
UriFind Test has much better sensitivity compared to urine cytology and FISH tests for low-grade and Ta tumors
Clinical studies involving multiple patient cohorts indicate that the UriFind test has significantly higher sensitivity compared to urine cytology and urine FISH. The higher sensitivity in low-grade and Ta tumors is critical for bladder cancer early detection, significantly reducing the number of these patients missed by the two common testing methods. Early detection could mean early treatment, decreasing the chances of these patients developing high-grade tumors that have a poorer prognosis.
Clinical Performance
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Sensitivities
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Positive Predictive Value
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Accuracy
%
Specificity
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Negative predictive value
UriFind Urothelial Carcinoma Test
UriFind is available at DiaCarta Clinical Laboratory as a Lab-Developed-Test (LDT).
Contact DiaCarta Lab at support@diacarta.com to set up an account and order sample collection kit.
- Download the account setup form.
Send FFPE samples to the DiaCarta lab with complimentary FedEx overnight shipping label.
- Download the Sample Requirement and Shipping Instruction.
- Download the Test Requisition Form.
Review your test results through our secure online portal or receive them via encrypted email.
- Turnaround time: 2 weeks
What payment options are available?
We accept insurance billing as well as direct cash payments. Coverage may vary based on your provider.
Is the UriFind test covered by insurance?
Yes, we bill your insurance to cover the basic cost of the test. Coverage depends on your provider and plan. If insurance does not cover it, we offer a cash payment option.
Is financial assistance available?
Yes! Please contact us at support@diacarta.com to discuss available options if you have concerns about payment or insurance.
What happens after my doctor orders the test?
Your doctor’s office will arrange the sample collection and manage the shipping for you. Once the test is complete, the results will be delivered directly to your doctor.
Resources
Disclaimer: The UriFind Urothelial Carcinoma Test, a laboratory-developed test (LDT), is performed at our CLIA-certified and CAP-accredited laboratory in California, USA. The test is intended for use in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of urothelial carcinoma in patients with hematuria, bladder irritation, or abnormalities detected through non-invasive methods like imaging. However, it should not be solely relied upon for tumor diagnosis or suspected of having bladder cancer. The test has been analytically validated by the laboratory but is not cleared or approved by the U.S. Food and Drug Administration (FDA). For further details or to speak with a support specialist, please contact DiaCarta Clinical Laboratory at support@diacarta.com.”