{"id":7055,"date":"2023-03-29T09:35:28","date_gmt":"2023-03-29T16:35:28","guid":{"rendered":"https:\/\/www.promisdx.com\/?page_id=7055"},"modified":"2025-10-30T14:32:34","modified_gmt":"2025-10-30T21:32:34","slug":"bladdercancer","status":"publish","type":"page","link":"https:\/\/www.promisdx.com\/?page_id=7055","title":{"rendered":"Bladder Cancer"},"content":{"rendered":"

[vc_row full_width=”stretch_row_content_no_spaces” css=”.vc_custom_1679004334755{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column][vc_empty_space height=”” el_class=”header_news” css=”.vc_custom_1677866300945{background-image: url(https:\/\/www.promisdx.com\/wp-content\/uploads\/2022\/12\/newstemplateheader.png?id=6109) !important;}”][\/vc_column][\/vc_row][vc_section][vc_row layout=”boxed” css=”.vc_custom_1679094224168{padding-top: 1vw !important;}”][vc_column][vc_custom_heading text=”Bladder Cancer Detection with EarlyTect BCD” font_container=”tag:h2|text_align:left|color:%230074b7|line_height:1″ google_fonts=”font_family:Montserrat%3Aregular%2C700|font_style:400%20regular%3A400%3Anormal” el_class=”min-txt-body-head”][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1679004536863{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;padding-bottom: 1vw !important;}”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text css=”.vc_custom_1743025214064{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Clinical Utility<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_btn title=”Recommendations on when to be tested.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096623505{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094555452{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text”]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.\u00a0 It uses the EarlyTect urine collection kit and assay kit (including reagents) and the QuantStudio Dx Real-Time PCR Instrument.\u00a0The 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.[\/vc_column_text][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1677871864169{padding-bottom: 1vw !important;}”][vc_column width=”1\/2″][vc_row_inner css=”.vc_custom_1677871707439{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/2″ offset=”vc_col-xs-6″][vc_column_text css=”.vc_custom_1677884677560{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Methodology<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″ offset=”vc_hidden-sm vc_hidden-xs”][vc_btn title=”Process used to preform test.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096783702{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094749747{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text”]Linear Target Enrichment-quantitative methylation-specific real-time PCR (LTE-qMSP)[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_row_inner css=”.vc_custom_1677871713224{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/2″ offset=”vc_col-xs-6″][vc_column_text css=”.vc_custom_1743024812351{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Turn Around Time<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″ offset=”vc_hidden-sm vc_hidden-xs”][vc_btn title=”Approximate turnaround time (starting from when PromisDx receives sample).” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096818659{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094767387{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text”]2 – 7 days[\/vc_column_text][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1677871872560{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;padding-bottom: 1vw !important;}”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text css=”.vc_custom_1677884693044{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Submit with Order<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_btn title=”Forms, items, and information that needs to be submitted.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096838384{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094790946{margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_row_inner gap=”5″][vc_column_inner width=”1\/3″][vc_raw_html]JTNDYSUyMGhyZWYlM0QlMjJodHRwcyUzQSUyRiUyRnd3dy5wcm9taXNkeC5jb20lMkZ3cC1jb250ZW50JTJGdXBsb2FkcyUyRjIwMjUlMkYwOSUyRlBEWF9FYXJseVRlY3RfQkNEX1JlcV9Gb3JtX1dpdGgtVUEucGRmJTIyJTIwdGFyZ2V0JTNEJTIyX2JsYW5rJTIyJTIwcmVsJTNEJTIybm9vcGVuZXIlMjBub3JlZmVycmVyJTIyJTNF[\/vc_raw_html][vc_single_image image=”7765″ img_size=”” alignment=”center” style=”vc_box_border” css=”.vc_custom_1759279530939{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”pic1″][vc_column_text el_class=”body-text no-hl”]<\/p>\n

Requisition Form<\/p>\n

[\/vc_column_text][vc_raw_html]JTNDJTJGYSUzRQ==[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=”1\/3″][vc_raw_html]JTNDYSUyMGhyZWYlM0QlMjJodHRwcyUzQSUyRiUyRnd3dy5wcm9taXNkeC5jb20lMkZ3cC1jb250ZW50JTJGdXBsb2FkcyUyRjIwMjUlMkYwMiUyRlBvc2l0aXZlLXJlcG9ydC5wZGYlMjIlMjB0YXJnZXQlM0QlMjJfYmxhbmslMjIlMjByZWwlM0QlMjJub29wZW5lciUyMG5vcmVmZXJyZXIlMjIlM0U=[\/vc_raw_html][vc_single_image image=”7570″ img_size=”” alignment=”center” style=”vc_box_border” css=”.vc_custom_1706149629548{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”pic1″][vc_column_text el_class=”body-text no-hl”]<\/p>\n

Positive Sample Report<\/p>\n

[\/vc_column_text][vc_raw_html]JTNDJTJGYSUzRQ==[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=”1\/3″][vc_raw_html]JTNDYSUyMGhyZWYlM0QlMjJodHRwcyUzQSUyRiUyRnd3dy5wcm9taXNkeC5jb20lMkZ3cC1jb250ZW50JTJGdXBsb2FkcyUyRjIwMjUlMkYwMiUyRk5lZ2F0aXZlLXJlcG9ydC5wZGYlMjIlMjB0YXJnZXQlM0QlMjJfYmxhbmslMjIlMjByZWwlM0QlMjJub29wZW5lciUyMG5vcmVmZXJyZXIlMjIlM0U=[\/vc_raw_html][vc_single_image image=”7569″ img_size=”” alignment=”center” style=”vc_box_border” css=”.vc_custom_1706149647164{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”pic1″][vc_column_text el_class=”body-text no-hl”]<\/p>\n

Negative Sample Report<\/p>\n

[\/vc_column_text][vc_raw_html]JTNDJTJGYSUzRQ==[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1677871881343{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;padding-bottom: 1vw !important;}”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text css=”.vc_custom_1677884701677{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Specimen Required<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_btn title=”Patient Preparation: Instructions patient must follow before\/during specimen collection. Collect: Specimen type to collect. May include collection media, tubes, kits, etc. Specimen Preparation: Instructions for specimen prep before\/after collection and prior to transport. Storage\/Transport Temperature: Preferred temperatures for storage prior to and during shipping. Unacceptable Conditions: Common conditions under which a specimen will be rejected. Remarks: Additional specimen collection, transport, or test submission information. Stability: Acceptable times\/temperatures for specimens.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096860764{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679079195906{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_row_inner equal_height=”yes” css=”.vc_custom_1743207507466{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743207442596{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;}”][vc_column_text el_class=”body-text realign” css=”.vc_custom_1679089310872{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Patient Preparation:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743207472166{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743207487812{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Mid-stream clean catch, random, first-morning, or post-prandial urine[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743207639871{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743207533690{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text realign” css=”.vc_custom_1743024873574{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Specimen Type:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ css=”.vc_custom_1679084408820{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743207549195{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Urine[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743208682827{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743208620206{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text realign” css=”.vc_custom_1743025062510{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Collection Device:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ css=”.vc_custom_1743208662022{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743208646767{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Sterile urine cup[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743208769846{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ css=”.vc_custom_1743208702634{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}” offset=”vc_col-xs-12″][vc_column_text el_class=”body-text realign” css=”.vc_custom_1679090442286{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Specimen Preparation:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743208745744{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743208728562{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Collecting 20 ml of void urine in 50 ml tube with a preservative provided by Promis DX.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743208867226{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ css=”.vc_custom_1743208798410{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}” offset=”vc_col-xs-12″][vc_column_text el_class=”body-text realign” css=”.vc_custom_1679090457393{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Storage\/Transport Temperature:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743208830104{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743208844932{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]<\/p>\n

Storage:<\/em> 2-8\u00b0C for up to 14 days.<\/p>\n

Transport:<\/em> 15-30\u00b0C<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743208957324{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ css=”.vc_custom_1743208896741{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text realign” css=”.vc_custom_1743024914211{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Rejection Criteria:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ css=”.vc_custom_1743208925113{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743208939379{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]<\/p>\n

1. Urine specimen not in the urine collection container provided by the manufacturer.
\n2. Specimen with a damaged container or missing label.
\n3. Specimen stored for more than stated stability after collection.
\n4. Specimen with a volume of preservative in the collection container below the baseline, where urine was collected.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=”yes” content_placement=”top” css=”.vc_custom_1743209042811{margin-top: 0.5vw !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_inner width=”1\/6″ css=”.vc_custom_1743208974949{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-right-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;}” offset=”vc_col-xs-12″][vc_column_text el_class=”body-text realign” css=”.vc_custom_1743208988899{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]Stability:<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”5\/6″ offset=”vc_col-xs-12″ css=”.vc_custom_1743209003425{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text” css=”.vc_custom_1743209023223{margin-top: 0px !important;margin-bottom: 0px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]<\/p>\n

Ambient:<\/em> 14 days<\/p>\n

Refrigerated:<\/em> 14 days<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1677871888796{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;padding-bottom: 1vw !important;}”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text css=”.vc_custom_1677884711172{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]Notes<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_btn title=”Additional information related to test.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096878533{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094834076{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text”]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.\u00a0 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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).<\/p>\n

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.[\/vc_column_text][\/vc_column][\/vc_row][vc_row layout=”boxed” css=”.vc_custom_1708552919817{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;padding-bottom: 2vw !important;}”][vc_column][vc_row_inner][vc_column_inner width=”1\/2″][vc_column_text css=”.vc_custom_1677884764090{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”small-text”]CPT Codes<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_btn title=”The American Medical Association Current Procedural Terminology (CPT) codes published in Promis’ Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually.” style=”flat” color=”white” align=”right” i_align=”right” i_icon_fontawesome=”fas fa-info-circle” add_icon=”true” css=”.vc_custom_1679096897791{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}” el_class=”gone”][\/vc_column_inner][\/vc_row_inner][vc_separator css=”.vc_custom_1679094863456{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}”][vc_column_text el_class=”body-text”]0452U<\/p>\n

81401[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_row][vc_column][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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