Cleo Diagnostics

December 2023 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the December 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.


  • First clinical validation study of the CleoDX Triage Test, performed in a 334 patient cohort, was published in peer-reviewed journal “Cancers” which detailed the high performance of Cleo’s ovarian cancer diagnostics test:
    • Highly accurate with 95% sensitivity1 / 95% specificity2;
    • Correctly discriminated malignant from benign samples; and
    • Out-performed and was superior to current clinical methods.
  • Important commercial foundation progress delivered with biomarkers panel for Cleo’s ovarian cancer test-kit finalised and antibody development advanced that will underpin the consistent and reliable manufacture of test-kits
  • Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, commencing in a full-time capacity
  • A$10.1M cash at bank at 31 December 2023

Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer- reviewed international journal ‘Cancers’. The results confirm the high accuracy of the CleoDX Triage Test, which was independent of menopausal status, and showed that it out-performed the two most widely used clinical scoring systems (the “Risk of Malignancy Index” and “Risk of Malignancy Algorithm”) for discriminating benign from malignant ovarian disease.

A copy of the publication is available here:

Moreover, the CleoDX surgical triage test correctly identified 81% of early-stage cancer patients in the cohort.

The next step in development will confirm functionality of the commercially available kits in an independent clinical trial, the results of which will be submitted to the FDA for regulatory approval. Cleo anticipates commencement of this trial early in CY2024.

Click here for the full ASX Release

This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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Appendix 4D and Half Yearly Accounts

Cleo Diagnostics Limited (ASX:COV) (Cleo, or the Company) is bringing to market a simple blood test for the accurate and early diagnosis of ovarian cancer, using its novel patented CXCL10 biomarker. Cleo's first test - AdnexaSureTM is designed to distinguish benign from malignant growths and will be compatible with standard diagnostic laboratory workflows worldwide.

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Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it is marking its 10-year anniversary, and celebrating a decade of expansion and growth.

Since its inception on February 28, 2014, Knight has delivered significant milestones and made progress on its strategy of building a profitable pan-American (ex US) company commercializing both innovative and branded generic pharmaceuticals products and talented people.

Key Accomplishments:

  1. Built a Unique Platform in Canada & Latin America

    Knight has invested over $925 million to build its unique pan-American (ex US) platform of innovative and branded generic pharmaceuticals. Today, Knight has over 700 talented employees operating in Canada and 10 Latin American markets. Knight is a fully integrated company with capabilities spanning regulatory, quality, pharmacovigilance, compliance, medical, market access, marketing, sales and supply chain in all 11 countries, as well as branded generic development and manufacturing capabilities in Argentina.

  2. Delivered Profitable Growth

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  3. Partner of Choice

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  4. Strong Pipeline Expected to Deliver Over $120 Million in Peak Revenues

    Knight has assembled a strong pipeline across our territories of 17 products which include products in early launch or in various stages of development. The products are projected to be launched by 2028 and Knight has advanced the pipeline with the submission of 8 of these products for regulatory approval in at least one country.

When reflecting on Knight's accomplishments since founding, Jonathan Ross Goodman, Knight's Executive Chairman, said "We are doing exactly what we said we would do in 2014 – we built a fabulous pharmaceutical company with talented motivated Knights delivering pharmaceuticals to Canadians and Latin Americans. During these 10 years, we have generated $379 million 1 and we will continue to strengthen on our platform and bring shareholder value."

"I am incredibly proud of what we have accomplished to date and I am excited about the future achievements that we will deliver to all of our stakeholders. None of this would be possible without the fantastic team that we have in place across all our countries. Their unwavering commitment and dedication to serving patients have been instrumental in shaping Knight as the partner of choice for Canada and Latin America," said Samira Sakhia, President and Chief Executive Officer.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at or .

Forwa rd-Looking Statements

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2022, as filed on . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.


Investor Contact:
Knight Therapeutics Inc.
Samira Sakhia Arvind Utchanah
President & Chief Executive Officer Chief Financial Officer
T: 514.484.4483 T. +598.2626.2344
F: 514.481.4116
Email: Email:
Website: Website:

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