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Cleo Diagnostics Ltd

0.317

-0.013-3.94%

Volume:39.57K

Turnover:12.62K

Market Cap:43.39M

PE:-10.57

High:0.322

Open:0.320

Low:0.315

Close:0.330

52wk High:0.900

52wk Low:0.310

Shares:136.86M

Float Shares:73.01M

Volume Ratio:0.32

T/O Rate:0.05%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.030

EPS(LYR):-0.031

ROE:-109.48%

ROA:-50.01%

PB:8.66

PE(LYR):-10.19

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Overview Company News Filings

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

ASX Opportunities: Alcidion Group Among 3 Promising Penny Stocks

Simply Wall St.

Cleo Diagnostics Achieves Recruitment Target for US Pre-Surgical Ovarian Cancer Test Trial

MT Newswires Live

Cleo Diagnostics Selects Bio-Techne's Platform as Immunoassay Instrument for Ovarian Cancer Blood Test; Shares Jump 3%

MT Newswires Live

ASX Penny Stocks Under A$500M Market Cap: 3 Promising Picks

Simply Wall St.

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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":"sg","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":"fut","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","BK4585","COV.AU","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":["COV.AU","BK7067"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2629065663","title":"ASX Opportunities: Alcidion Group Among 3 Promising Penny Stocks","url":"https://stock-news.laohu8.com/highlight/detail?id=2629065663","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2629065663?lang=en_us&edition=fundamental","pubTime":"2026-04-22 03:02","pubTimestamp":1776798158,"startTime":"0","endTime":"0","summary":"Australian shares are poised for a modest gain, contrasting with Wall Street's recent declines, as investors navigate global uncertainties and regional developments. In this context, penny stocks—often representing smaller or newer companies—offer intriguing opportunities for growth at accessible price points. Despite being an older term, these stocks can still hold significant potential when backed by strong financial health and solid fundamentals.","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/8031000-choice2-main-header/1585186598236","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/8031000-choice2-main-header/1585186598236"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/software/asx-kyp/kinatico-shares/news/asx-opportunities-alcidion-group-among-3-promising-penny-sto","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/software/asx-kyp/kinatico-shares/news/asx-opportunities-alcidion-group-among-3-promising-penny-sto","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"simplywall_highlight","symbols":["BK7016","BK7067","BK7503","COV.AU","BK7132","CLX.AU","LBL.AU","OBM.AU","BK7058","WAF.AU","BK7062","BK7094","EDU.AU","BK7104","KYP.AU","IRI.AU","BK7061","RPL.AU","AEF.AU","BK7088","BK7506","PPS.AU","CGS.AU","ALC.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2623718376","title":"Cleo Diagnostics Achieves Recruitment Target for US Pre-Surgical Ovarian Cancer Test Trial","url":"https://stock-news.laohu8.com/highlight/detail?id=2623718376","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2623718376?lang=en_us&edition=fundamental","pubTime":"2026-03-31 10:00","pubTimestamp":1774922413,"startTime":"0","endTime":"0","summary":"Cleo Diagnostics  achieved its recruitment target, with 514 blood samples collected and 624 women enrolled across 19 US sites for its clinical trial for its pre-surgical ovarian cancer test, according to a Tuesday Australian bourse filing.The trial seeks to benchmark the test against existing tools used to assess the risk of ovarian malignancy in women with an adnexal mass for whom surgery is planned. It was designed to recruit a minimum of 500 women.It is also in final discussions with a manufacturing partner to enter into a binding agreement for test kit production, after the completion of its biomarker panel optimization.Its shares fell 1% in recent trading 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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7067","COV.AU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2612492145","title":"Cleo Diagnostics Selects Bio-Techne's Platform as Immunoassay Instrument for Ovarian Cancer Blood Test; Shares Jump 3%","url":"https://stock-news.laohu8.com/highlight/detail?id=2612492145","media":"MT Newswires Live","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612492145?lang=en_us&edition=fundamental","pubTime":"2026-02-18 10:12","pubTimestamp":1771380745,"startTime":"0","endTime":"0","summary":"Cleo Diagnostics  selected Bio-Techne's Ella enzyme-linked immunosorbent assay platform as the immunoassay instrument for its ovarian cancer blood test, according to a Wednesday Australian bourse filing.The companies are progressing discussions to enter into a binding agreement to start analytical validation of Cleo's test kits, the filing said. Cleo has been using the Ella platform in-house since September 2025 and confirmed the platform's capability to deliver its tests.The finished kits will then be used test the around 500 blood samples collected as part of Cleo's pivotal clinical trial, per the filing.Cleo Diagnostics' shares jumped nearly 3% in recent trading on Wednesday.","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":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["TECH","BK4588","BK4121","IE00B19Z6F94.USD","COV.AU","BK7067","IE0034390439.USD","IE00B64QTZ34.USD","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2603957290","title":"ASX Penny Stocks Under A$500M Market Cap: 3 Promising Picks","url":"https://stock-news.laohu8.com/highlight/detail?id=2603957290","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2603957290?lang=en_us&edition=fundamental","pubTime":"2026-01-16 10:08","pubTimestamp":1768529332,"startTime":"0","endTime":"0","summary":"The Australian market today presents a mixed outlook, with the Aussie dollar inching closer to 67 cents against the USD and equities poised for a flat opening. For investors interested in exploring beyond well-known names, penny stocks—typically smaller or newer companies—offer intriguing possibilities. Despite the term's outdated feel, these stocks can still provide surprising value when backed by solid financials, offering potential for significant returns and stability.","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/3051000-choice1-main-header/1585186568557","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/3051000-choice1-main-header/1585186568557"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/capital-goods/asx-sks/sks-technologies-group-shares/news/asx-penny-stocks-under-a500m-market-cap-3-promising-picks","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/capital-goods/asx-sks/sks-technologies-group-shares/news/asx-penny-stocks-under-a500m-market-cap-3-promising-picks","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":"simplywall_highlight","symbols":["MTO.AU","BK7016","BK7143","BK7055","SKS.AU","MXI.AU","BK7132","BK7104","BK7506","VRS.AU","DSK.AU","PPL.AU","BK7067","BK7058","PPS.AU","BK7503","COV.AU","KSC.AU","BK7050","EDU.AU","BK7061","WAF.AU","BK7077","BK7128","IGL.AU","SSM.AU","BK7045","BK7023"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":1,"pageCount":1,"totalSize":8,"code":"91000000","status":"200"}]}}