We are proud to announce the launch of EarlyTect® BCD! Learn more here.

Bladder Cancer Detection with EarlyTect® BCD

Ordering Recommendation

Hematuria patient and/or risk of bladder cancer. Urine with blood in it.

Methodology

Linear Target Enrichment-quantitative methylation-specific real-time PCR (LTE-qMSP)

Reported

2 – 7 days

Submit with Order

Requisition Form

Positive Sample Report

Negative Sample Report

Specimen Required

Patient Preparation:

Collect:

Urine

Specimen Preparation:

Collecting 20 ml of void urine in 50 ml tube with a preservative provided by Promis DX.

Storage/Transport Temperature:

Storage: 2-8°C for up to 7 – 14 days.

Transport: 15-30°C

Unacceptable Conditions:

1. Unsampled urine specimen in the urine collection container provided by the manufacturer.
2. Specimen with a damaged container or missing label.
3. Specimen stored for more than 7 days after collection.
4. Specimen with a volume of preservative in the collection container below the baseline, where urine was collected.

Stability:

Ambient: 72 hrs

Refrigerated: 14 days

Notes

The EarlyTect® Bladder Cancer (BC) is an proprietary in vitro diagnostic device designed to detect the presence of BC by analyzing urine DNA for patients through qualitative analysis of a single epigenetic biomarker gene DNA methylation (methylated PENK DNA). The EarlyTect® BC is for use with a real-time, methylation-specific PCR detection system coupled with linear target enrichment step after DNA extraction and bisulfite conversion. It detects both methylated PENK and an internal control gene.

Limitation: Improper specimen collection techniques, storage, or shipment protocols may cause unreliable results. An absence of detection does not imply the absence of bladder cancer or does not exclude the possibility that the target sequence is present below the limit of detection. The EarlyTect® BC Report does not take into consideration patient history, drug-drug interactions, drug sensitivity, and/or allergies. It is the responsibility of the physician to determine appropriate drug and dosing choices based on all available data.

Result Interpretation: A positive result indicates the possibility of bladder cancer (BC). A positive result is not confirmatory evidence for bladder cancer. Patients with a positive EarlyTect BC test result should be referred for diagnostic cystoscopy. A negative result indicates lower likelihood of bladder cancer. A negative EarlyTect BC test result does not guarantee absence of cancer. Patients with a negative EarlyTect® test result should be advised to continue participating in a recommended Bladder cancer screening program according to screening guidelines. This test confirmed that patients with hematuria can be diagnosed with 85.7% accuracy for all stages BC and 90% accuracy for TaHG and higher stages BC in clinical trials. At about 10-15% of the level, it can be negative (false negative) on the test, even if it is not negative. In this case, the possibility of a bladder cancer cannot be completely ruled out.

 
The information contained in this report is intended to be interpreted by a licensed physician or other licensed healthcare professional. This report is not intended to take the place of professional medical advice. Decisions regarding use of prescribed medications must be made only after consulting with a licensed physician or other licensed healthcare professional, and should consider each patient’s medical history, and current treatment regimen.

CPT Codes

81401

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