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Cleo Diagnostics Ltd

0.360

+0.0154.35%

Volume:45.98K

Turnover:15.80K

Market Cap:51.26M

PE:-8.05

High:0.360

Open:0.345

Low:0.340

Close:0.345

52wk High:0.900

52wk Low:0.310

Shares:142.38M

Float Shares:73.01M

Volume Ratio:1.11

T/O Rate:0.06%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.045

EPS(LYR):-0.045

ROE:-109.48%

ROA:-52.15%

PB:10.23

PE(LYR):-8.05

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News

Cleo Diagnostics Enters Analytical Validation Phase for Ovarian Cancer Blood Test; Shares Fall 6%

MT Newswires Live

Cleo Diagnostics Outlines US Commercialization Strategy for Ovarian Cancer Test Ahead of FDA Clearance

MT Newswires Live

Cleo Diagnostics Starts Manufacturing, Development Program for Ovarian Cancer Test Kit Production; Shares Up 8%

MT Newswires Live

Cleo Diagnostics Ltd-Cleo Commences Kit Manufacturing Ahead of FDA Submission

THOMSON REUTERS

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The company will evaluate three independently manufactured production batches to demonstrate assay reproducibility, manufacturing consistency, and overall analytical robustness.The company said it expects analytical validation to take around four months to complete, adding that it anticipates US Food and Drug Administration submission to occur in the first half of 2027.Cleo Diagnostics' shares fell nearly 6% in ","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7067","COV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2636899132","title":"Cleo Diagnostics Outlines US Commercialization Strategy for Ovarian Cancer Test Ahead of FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2636899132","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2636899132?lang=en_us&edition=fundamental","pubTime":"2026-05-20 09:53","pubTimestamp":1779241990,"startTime":"0","endTime":"0","summary":"Cleo Diagnostics  said it plans to enter the US market immediately following anticipated Food and Drug Administration  clearance for its pre-surgical ovarian cancer test, enabling early billing and real-world utilization data capture, according to a Wednesday Australian bourse filing.The company said reimbursement will be determined via cross-walking to comparable multi-biomarker tests, which have reported reimbursements of around $500 to $900 per test, supporting initial pricing discussions.The approach represents the first step toward securing a dedicated CPT code to support long-term reimbursement and commercial scale, the filing added.The company's shares rose 1% in recent Wednesday trade.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["COV.AU","BK4585","BK7067","BK4588","LABU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630328588","title":"Cleo Diagnostics Starts Manufacturing, Development Program for Ovarian Cancer Test Kit Production; Shares Up 8%","url":"https://stock-news.laohu8.com/highlight/detail?id=2630328588","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630328588?lang=en_us&edition=fundamental","pubTime":"2026-04-28 10:50","pubTimestamp":1777344604,"startTime":"0","endTime":"0","summary":"Cleo Diagnostics  started a staged manufacturing and development program with life sciences firm Bio-Techne to support production of its ovarian cancer test kits, according to a Tuesday filing with the Australian bourse.The program will generate the test kits required for analytical validation and the evaluation of the clinical samples collected as part of the company's US study, the filing said.Data from analytical validation and clinical sample testing will form the core evidence package for the company's US Food and Drug Administration 510 submission, per the filing.Cleo Diagnostics shares rose 8% in midday trade on Tuesday.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7067","COV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2630345677","title":"Cleo Diagnostics Ltd-Cleo Commences Kit Manufacturing Ahead of FDA Submission","url":"https://stock-news.laohu8.com/highlight/detail?id=2630345677","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2630345677?lang=en_us&edition=fundamental","pubTime":"2026-04-28 06:26","pubTimestamp":1777328808,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260427:nTUEBKGSYN:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK7067","COV.AU"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":4,"totalPage":2,"pageCount":1,"totalSize":8,"code":"91000000","status":"200"}],"@#url:\"https://hq.skytigris.cn/market/plate/belongs/COV.AU\",params:#limit:6,delay:true,,,undefined,":[]}}