A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
Highlights
The authors concluded that TruScreen “represents a reliable, practical screening tool for cervical neoplasms” and that their results “provide an evidence-based approach for policymakers when selecting the optimal cervical cancer screening strategy in countries without an established national screening program.”
This study reinforces TruScreen’s commitment to providing innovative and accessible healthcare solutions. The positive results validate TruScreen’s technology and opens new opportunities in the global healthcare market.
For more information, please visit our website at www.truscreen.com.
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Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, chairman, president and chief executive officer, will present at the Morgan Stanley 22 nd Annual Global Healthcare Conference on Thursday, September 5, 2024 at 8:30 a.m. (EDT).
You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com .
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
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Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 2024 Wells Fargo Healthcare Conference on Wednesday, September 4, 2024 .
Geoff Martha , Medtronic chairman and chief executive officer, will answer questions on the medtech industry and on the company beginning at approximately 11:55 a.m. EDT ( 12:55 p.m. CDT ).
A live webcast of the Q&A session will be available on September 4, 2024 , by clicking on the Events link at http://investorrelations.medtronic.com . An archive of the session will be available on the same webpage later in the day.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn .
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MedtronicMedtronic has taken measurable steps to drive change
Doctors have used pulse oximeters for more than 40 years, but the pandemic put the devices in the spotlight after studies found they may not be accurate across all skin tones.
"What we saw during the pandemic was health disparities," said Bradley, who works in sales in the Acute Care & Monitoring (ACM) business at Medtronic. "We recognize that patients of color were not faring as well as their lighter skin counterparts."
In her presentations, Bradley, the mother of a multiracial daughter, elaborates on why the devices can sometimes fall short. She calls it "technology bias."
There's a lot we still don't understand about what drives that bias, but we know low perfusion, or the flow of blood to cells and tissues, along with skin pigmentation, and user error, are at the core.1
While our pulse oximeter, Nellcor™, has delivered monitoring solutions for decades, Medtronic can do better, ACM President Frank Chan said. It's why the company has taken measurable steps to drive change, such as participating in a U.S. Food and Drug Administration panel on the accuracy of pulse oximeters and opening a physiology lab in a racially diverse neighborhood to ensure inclusive clinical trial enrollment and participation.
"We saw all the studies coming out of the pandemic around equity and pulse oximetry and delivering safe care," said Chief Medical Officer for ACM Dr. Sam Ajizian. "We accelerated our work. In doing so, we aim to do the right thing for the patient."
What is a pulse oximeter?
Dr. Ajizian was a young physician when pulse oximeters were first introduced to the marketplace. They were a "transformative" tool that removed the guesswork in measuring the amount of oxygen in a patient's blood - and alerting doctors when more may be needed.
If you've had surgery, ridden in an ambulance, or even visited a clinic, chances are a pulse oximeter has been clipped to the end of your finger.
"It's kind of magical to be able to take something on the outside of the body and use it to measure how much oxygen is going to the tissue that's contained in the blood on the inside of the body," Dr. Ajizian said.
While pulse oximeters are essential to patient safety, not all are created equal. In a recent study enrolling healthy volunteers to measure the effects of skin pigmentation and perfusion index on pulse oximeter accuracy, one of the company's competitor's devices, for example, missed 30% of hypoxemic events, or when there's an abnormally low amount of oxygen in the blood. Nellcor™ pulse oximeters, on the other hand, missed 7.9%, said Vice President of Research & Development for ACM Jason Case.1
"The goal isn't to be better than everyone else," Case said. "The goal is to provide a solution that works for everybody. How do we get that 7.9% to zero, independent of if you have thick skin, dark skin, or low perfusion?"
Walking the walk
The commitment to getting it right - every time - is why the company opened a clinical physiology lab near the Five Points neighborhood of Denver, Colorado. It's a racially diverse area where community members can easily access the unassuming lab, which is embedded within a larger medical complex. Many trial participants walk to the lab from their homes.
"We decided to locate this lab in Denver, away from the central offices of Medtronic, and it has proven to be the right choice," said Lab Manager Roger Martin-Pressman. "To make it convenient for people from diverse backgrounds to access these research opportunities was really important to me."
The lab empowers the company to conduct its own clinical trials, meaning it can test devices with more speed and frequency and, in turn, innovate quickly. "We really want devices to get better based on the data we collect here," Martin-Pressman said. "And not just better so clinicians understand how to use them, but also better so that people who wear them have better outcomes."
The larger, more diverse data set being collected at the lab is critical to research and development work at Medtronic, Case said. It ensures we're approaching our work with equity before it leaves the innovation lab.
Building trust
Obioma Nwankwo is a clinical studies coordinator for the clinical physiology lab in Denver. She recruits trial participants and often leads engagement events in the community, such as hosting booths at the city's Juneteenth festival, to build trust within the community and educate about the trials and our commitment to health equity.
"Sometimes the end goal is not always getting someone in the chair and having them come and do the study," Obioma said. "Sometimes the end goal is just spreading awareness, or having a conversation."
But the community is responding; trial enrollment continues to tick upward. The lab has already enrolled more than 130 participants and will continuously recruit. The opportunity to be part of a clinical trial that could improve device accuracy across all skin pigmentations was a driving factor for Zahra Abdullahi to enroll.
"As a minority in the healthcare system, a lot of things are overlooked," said Abdullahi, a college student studying engineering. "I'm doing this not only for my safety, but for others' as well. I have siblings and friends who are also minorities and making sure they have accurate representation in healthcare is very important."
Lasting change
When Bradley first began her career in 1991, working as a respiratory therapist for neonatal and pediatric patients, she would have argued there weren't health disparities in her work.
"When I look retrospectively on it, I recognize that's not true, there probably always were some biases," she said, adding anyone who wants to be "intellectually honest" would agree there are disparities in the access and provision of healthcare.
Even though the Medtronic pulse oximetry device meets all current FDA standards, those questions about health equity are spurring broader change, and Medtronic is making meaningful contributions.
"I'm proud that Medtronic has taken a stance to say that's not good enough," Bradley said.
Not to mention, it's just the right thing to do, said Martin-Pressman, the lab manager.
"Equality is giving everybody the same opportunity, but equity is ensuring the outcome is the same," he said.
Ronda Bradley, left, with her family.
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