The EarlyTect BCD is intended for the qualitative detection of the a single epigenetic methylation biomarker (PENK) associated with bladder cancer in urine DNA from patients with hematuria.  It uses the EarlyTect urine collection kit and assay kit (including reagents) and the QuantStudio Dx Real-Time PCR Instrument. The EarlyTect BCD is indicated for use by the qualified healthcare professionals as a non-invasive method and an aid in the diagnosis of bladder cancer from patients with hematuria in conjunction with cystoscopy and cytology.

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.  The FDA has granted Breakthrough Device Designation to EarlyTect BCD as a non-invasive, urine-based diagnosis of bladder cancer from patients with hematuria in April 2023.

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.

Disclaimer: This is a lab developed test and its performance characteristics determined by Promis Dx. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has been determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research. The laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 as qualified to perform high complexity clinical testing and is accredited by the College of American Pathologists (CAP).

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.

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