Cleo Diagnostics

CLEO Appoints Partner to Commence U.S. Market Access Program

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the appointment of New York- based HcFocus as a key partner for its U.S. market access program.


Highlights

  • CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its U.S. market access program
  • HcFocus will provide specialised and strategic expertise to assist CLEO to navigate the complexities of U.S. health systems and the regulatory environment
  • The U.S. program will focus on a roadmap to achieve FDA approval, reimbursement, a clinical trial, as well as industry and doctor engagement
  • Ultimately, the partnership will ensure CLEO achieves regulatory approval in the U.S. and can deliver early revenue from its ovarian cancer blood test in the world’s largest diagnostic market.
U.S. Market Access Program

The U.S. represents CLEO’s largest market opportunity for its ovarian cancer blood test and is the focus for initial regulatory approval through the Food and Drug Administration (FDA). In order to successfully execute on its U.S. market entry plan, CLEO will partner with New York-based strategic healthcare consultancy, HcFocus, appointing the company now to assist it with commencing commercial activities.

HcFocus specialises in helping med-tech companies access the U.S. healthcare market by leveraging their deep healthcare industry experience and networks to deliver market access results.

CLEO will leverage HcFocus’ expertise to navigate the complexities of U.S. health systems and regulatory environment, with the companies to focus on a roadmap to achieve:

  • FDA approval for CLEO’s ovarian cancer blood test;
  • Reimbursement, including with private insurers;
  • Clinical trials;
  • Support KOL appointments; and
  • Industry and doctor engagement.

The move to advance the U.S. market access program is well timed following two initial peer-reviewed publications recently released assessing the performance and benchmarking of CLEO’s ovarian cancer blood test. These publications detail the performance characteristics of the prototype triage test, which significantly exceeded comparable tests on market and the existing gold-standard biomarker, CA125 – the current guideline mandated test (See ASX Announcements 6 November 2023 and 25 March 2024).

CLEO’s publication strategy will underpin market access activities and is designed to publicise the test performance parameters and develop the clinical utility message, essentially building the clinical evidence bank required for doctors and insurers to support and adopt the prescribing of CLEO’s ovarian cancer blood test. HcFocus will be able to quickly assess the results from the initial peer-reviewed publications and provide guidance to ensure that Cleo’s evidence package will meet the needs of U.S. reimbursement bodies, including the private insurers. Further clinical evidence will be delivered in the coming months as the Company progresses towards the initial FDA 510(k) application for the pre- surgical triage test.

Commenting on the partnership with HcFocus, CLEO Chief Executive, Richard Allman, said:

“Dr Gross and the team at HcFocus are extremely well-credentialed with a wealth of practical experience navigating the U.S. healthcare system, private insurers and the FDA in the field of women’s health.

The commencement of CLEO’s U.S. market access program now sets us on a clear path to ensure that once we achieve regulatory approval, the Company can be in a strong position to deliver early revenue from its ovarian cancer blood test in the world’s largest diagnostic market.”

HcFocus President, Dr Susan Gross, added:

"HcFocus is delighted to aid CLEO's efforts in expanding this important technology for women's health into the U.S. market. As an Ob/GYN, I know that finding ways to identify this disease early will be a game changer".


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.

COV:AU
Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
Cleo Diagnostics

Cleo Diagnostics


Keep reading...Show less

Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, July 24, 2024

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the second quarter 2024 before the market opens on Wednesday, July 24, 2024, and will hold a conference call on the same day at 8:30 a.m. EDT.

During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 023107. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com . The earnings press release and related information can also be found in that section of our website under the heading "Financials." A replay of the call will be available under "News, Events & Presentations" through Wednesday, August 7, 2024.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic announces departure of Karen Parkhill, Chief Financial Officer

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Karen Parkhill will resign as executive vice president and chief financial officer to accept the role of chief financial officer for HP Inc.

"On behalf of our employees, our executive committee and our board of directors, I want to thank Karen for her leadership over the last eight years. I am personally grateful to Karen for her support through my transition to CEO, navigating the pandemic and delivering a new operating model for the company. We wish her all the best as she takes on the next chapter of her career," said Geoff Martha , Medtronic chairman and chief executive officer. "Across the company, we're building momentum with our innovation-driven growth strategy, and we remain focused and committed to delivering on our short- and longer-term financial objectives."

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

Cleo Commences U.S. Regulatory Process with FDA

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress in its regulatory strategy for its first commercial product, the pre-surgical triage test.

Keep reading...Show less

New MiniMed 780G system data demonstrates ability to address persistent blood sugar challenges for people with type 1 diabetes

With its advanced algorithm that provides autocorrections every 5 minutes, the latest data demonstrated that the MiniMed™ 780G system decreased rates of early morning hyperglycemia, known as dawn phenomenon, and improved overnight sleep

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, is presenting a comprehensive body of new data at the American Diabetes Association's (ADA) 84 th Scientific Sessions that showcases the benefits of the MiniMed™ 780G system. New data shows how the system addresses hyperglycemia and nighttime burden, adding to the established body of evidence that demonstrates the system's ability to tackle unique and burdensome challenges of diabetes, such as managing highs and meal-time management or carb counting, while also mirroring outcomes across a wide-ranging patient population.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Sempra Appoints Jennifer M. Kirk to Board of Directors

Sempra (NYSE: SRE) (BMV: SRE) today announced the appointment of Jennifer M. Kirk to the company's board of directors effective June 20 2024. Kirk is currently the global controller and chief accounting officer of Medtronic plc (NYSE: MDT) and has deep executive experience in finance, accounting and capital market activities, including more than 20 years in the energy industry.

Jennifer M. Kirk

"Bringing new perspectives into the boardroom is a critical component of our effort to support the company's mission to build North America's premier energy infrastructure company," said Jeffrey W. Martin , Sempra chairman and CEO. "Our board of directors embody a diverse set of skills, experiences and viewpoints that help guide Sempra's corporate strategy and overall business success. Jennifer's strong accounting and finance experience, coupled with her understanding of the energy business, will be a great complement to the board as we advance our corporate strategy and oversee financial discipline, risk management and ethical practices."

Before joining Medtronic, Kirk, 49, worked at Occidental Petroleum Corporation for more than two decades, serving in roles of increasing responsibility, including senior vice president of integration and value capture, and vice president, controller and principal accounting officer.

Kirk serves on the board of directors of Republic Services, where she is chair of the audit committee. She holds a bachelor's degree in economics from UC Santa Barbara and a master's degree in business administration from California State University, Bakersfield .

With the appointment of Kirk, Sempra will have 10 directors with three having been newly elected over the past five years, reflecting the company's commitment to periodic board refreshment to ensure fresh and diverse perspectives are present in the boardroom. Kirk will serve on the board's audit committee and the safety, sustainability and technology committee.

About Sempra
Sempra (NYSE: SRE) is a leading North American energy infrastructure company focused on delivering energy to nearly 40 million consumers. As owner of one of the largest energy networks on the continent, Sempra is electrifying and improving the energy resilience of some of the world's most significant economic markets, including California , Texas , Mexico and global energy markets. The company is recognized as a leader in sustainable business practices and for its high-performance culture focused on safety and operational excellence, as demonstrated by Sempra's inclusion in the Dow Jones Sustainability Index North America and in The Wall Street Journal's Best Managed Companies. More information about Sempra is available at sempra.com and on social media @Sempra .

Sempra Logo (PRNewsfoto/Sempra)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/sempra-appoints-jennifer-m-kirk-to-board-of-directors-302177421.html

SOURCE Sempra

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited

Cardiex Sales and Operations Update

On behalf of Cardiex (ASX:CDX) (the “Company”), I’m pleased to provide the following updates on recent progress across our business units.

Keep reading...Show less
Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×