Insight
Ending the guesswork in cancer care: A CEO’s vision for predictive precision oncology
By Wolfgang Hackl M.D., Founder & CEO, OncoGenomX Inc., Switzerland
During my career as an oncologist and cancer drug developer, one question haunted me more than any other: Why do some patients respond to therapy — while others, with the same diagnosis, do not?
We have innovative treatments, biomarkers, advanced lab tests, and guidelines. But far too often, despite all that science, our treatment decisions come down to educated guesswork.
As medicine evolves, so do our data — but not always our ability to act on it with precision.
That enduring gap between what we know and what we can predict inspired me to found OncoGenomX, and to build PredictionStar™, a platform designed to redefine what precision oncology truly means.
From Biomarkers to Behavior: The Missing Link
Today, most molecular cancer tests focus on eligibility: they tell us whether a tumour expresses a particular target or carries a known mutation. This is useful, but it’s only half the story.
Eligibility does not equal efficacy.
Knowing that a patient’s tumour expresses the estrogen receptor (ER), or harbours a PIK3CA mutation, doesn’t mean it will respond to hormone therapy or PI3K inhibition. It simply means those drugs might work. And in oncology, “might” is not enough.
PredictionStar™ was built to close this precision gap — by answering not just which drugs can be used, but which will actually work.
We call this Precision Drug–Tumor Matching: the ability to segregate effective from ineffective treatments by connecting genomic and phenotypic insights into a coherent tumour profile predictive of therapeutic response.
Introducing PredictionStar™: Coherent Biomarker Intelligence
PredictionStar™ is a multidimensional tumour profiling and decision-support system powered by what we term Generative Clinical Intelligence™ — the synthesis of high-quality sequencing data and AI-driven interpretation into clear, actionable clinical guidance.
Traditional assays analyse biomarkers in isolation, treating each gene mutation or expression pattern as a separate clue.
PredictionStar™ instead identifies logically connected biomarker constellations — genomic enablers that reveal which response mechanisms are active, and phenotypic differentiators how likely the tumour will respond.
This networked approach replaces fragmented snapshots with an integrated, functional map of tumour behaviour.
It provides oncologists with something they rarely get from today’s tests: confidence. In clinical modelling, PredictionStar™ has the potential to reduce overtreatment fivefold and lower the cost of achieving one year of tumour growth control by 35 per cent.
But the numbers tell only part of the story. Behind them are patients spared from unnecessary toxicity — and doctors empowered to treat with precision instead of probability.
Built on the Technology of Giants
PredictionStar™ was designed for seamless integration into modern real-world workflows, harmonized and cross-validated to ensure reliability, and reproducibility.
The platform’s pre-sequencing tumor workup is fully standardised, minimizing inter-laboratory variability that can otherwise reach 70 per cent.
From tumour processing to data interpretation, PredictionStar™ enforces the same rigorous quality in every step, producing consistent and concordant results across labs.
As far as cloud architecture optimized for medical data privacy and global scalability we are privileged to work with world class-players of the health IOT industry
(F. Gaede, Oct 2025, Nordcloud).
A Femtech Focus: Personalising Breast Cancer Therapy
While PredictionStar™ has broad oncology applications, our first focus is hormone receptor-positive breast cancer, the most prevalent form among women.
It is here that the limits of current diagnostics are most evident — and the need for predictive and prescriptive clarity is greatest.
Even within hormone-dependent breast cancer, the most favorable form of the disease, patient outcomes vary widely. Some women respond beautifully to endocrine therapy for years, while others progress rapidly.
What makes the difference? The answers are buried in the tumour’s individual response profiles — but until now, we lacked the tools to decode them. PredictionStar™ offers that decoding ability.
Our non-interventional validation study, conducted in collaboration with clinical researchers from the Veterans Affairs Medical Centers in Cincinnati, Los Angeles, and Miami, involves data from over 4,300 patients with hormone receptor-positive disease.
By correlating predicted responses with actual treatment outcomes, we aim to establish a new clinical standard for predictive accuracy.
Our roadmap includes RUO and LDT certification in 2026, FDA-IDE clearance in Q2 2027, first RUO test sales as early as Q1 2027, and clinical study use from Q3 2027 onwards.
Redefining Precision Oncology
To understand why this matters, we need to reframe what “precision” means.
Most tests today are prognostic or eligibility-based. They classify risk or confirm target presence. PredictionStar™ adds a third, transformative dimension: functional prediction. It asks, “Which therapies will this specific tumour respond to — and how strongly?”
This evolution turns diagnostics into a true decision-support tool, enabling oncologists to design treatment compositions optimized for efficacy, rather than constrained by averages.
The distinction may seem subtle, but its impact for individuals living with breast cancer is enormous: Prognostic and eligibility tests describe. PredictionStar™ guides.
Innovation Through Unity
Our strength lies in collaboration.
I’ve often said that OncoGenomX stands “on the technology of giants, powered by the ambition to transform.” That is more than a slogan — it’s our reality. We built PredictionStar™ not as an isolated product, but as a platform for partnership.
Its architecture invites integration — with hospital systems, sequencing providers, AI developers, and pharmaceutical R&D pipelines.
In the coming years, we envision PredictionStar™ evolving into a broader family of tools: PredictionStar DX™ for predictive diagnostics, PredictionStar GCI™ for data integration and generation of actionable clinical intelligence, and PredictionStar IOT™ for real-time connectivity. Each module serves the same purpose: to transform complexity into clarity.
From Data to Decisions: A Personal Reflection
At its heart, PredictionStar™ was born from empathy.
As a clinician, I saw too many patients fall through the cracks — not because we lacked treatments, but because we lacked foresight.
Data without interpretation is noise. Our mission is to turn that noise into understanding.
When I speak with oncologists today, I sense both excitement and relief: “We will no longer be limited to maybes.” “We can begin to quantify response likelihood, combine therapies more rationally, and give patients something we cannot give today: certainty”.
Technology can be transformative, but only when anchored in purpose. For OncoGenomX, that purpose is simple — to give every patient the best possible chance at lasting response.
The Road Ahead
Our journey is just beginning. We are validating, scaling, and expanding across cancer types — from breast to prostate, lung, and beyond.
But our guiding principle remains unchanged: wherever there is cancer, there is a need for precision drug–tumour matching.
The convergence of genomics, phenomics, AI, and clinical data is redefining healthcare.
PredictionStar™ is part of that transformation — proving that predictive precision is not a futuristic concept, but an attainable standard.
We owe it to patients, to clinicians, and to science itself to make that standard universal.
In Closing
When I founded OncoGenomX, I imagined a world where no cancer patient has to live with uncertainty — where treatment is guided by prediction, not probability.
Today, that world feels within reach. PredictionStar™ is more than technology. It’s a promise:
That every patient deserves clarity. That every tumour can be understood.
And that, together, we can end the guesswork in cancer care.
Contact: Dr. Wolfgang Hackl | Founder & CEO, OncoGenomX | E-Mail | LinkedIn WH | Company Webpage | LinkedIn OGX
Ki-67, a protein used to measure tumour growth, may also help prevent chromosome errors that drive cancer, a study suggests.
The findings could change how scientists view Ki-67, a marker commonly used in breast cancer and other tumours to assess how quickly cancer cells are growing.
Researchers found the protein may help preserve genome stability by maintaining the structural integrity of centromeres, key parts of chromosomes that help ensure DNA is shared correctly during cell division.
The research was led by professor Paola Vagnarelli at Brunel University of London in collaboration with scientists at the University of Edinburgh and the Technical University of Berlin.
Professor Vagnarelli said: “Doctors already measure Ki-67 to see how aggressive a cancer might be. But our results suggest it is actually helping maintain genome stability.
“That means it may be more than a marker. It could potentially also be a therapeutic target.”
The study examined three proteins that attach to chromosomes during cell division and help rebuild the molecular system that tells each new cell what kind of cell it is.
Every human cell carries identical DNA. What makes a liver cell different from a brain cell is which genes are switched on and which are kept inactive.
When a cell divides, that entire system of switches must be rebuilt. The three proteins involved in this process were Ki-67, Repo-Man and PNUTS.
Vagnarelli’s team developed a method that individually removes each protein from a living cell at the precise point of division. Older techniques could not isolate that moment cleanly.
They found that cells rely on all three proteins to reset themselves after division, but each failed in a different way when removed.
Without PNUTS, gene activity spiralled out of control and thousands of genes switched on at once.
Without Repo-Man, cells escaped safety checkpoints that usually stop damaged or abnormal cells from continuing to divide.
“What we didn’t expect was how clean the separation was,” said Vagnarelli.
Each protein fails in its own specific way. There is no redundancy, no safety net. Which means there are three separate points at which this process can go wrong.
“When the system breaks down, cells can emerge with the wrong number of chromosomes. That condition, called aneuploidy, is seen in disorders such as Down syndrome and in many cancers.
“We also found that these chromosome errors can trigger inflammatory signals inside the cell.”
Aneuploidy means a cell has too many or too few chromosomes, which can disrupt normal growth and function.
Inflammatory signals are chemical messages that can make a cell behave as if it is responding to injury or infection.
“These cells behave almost as if they are under attack,” said Vagnarelli.
“The immune response switches on because the genome is unstable.
“That link between chromosome imbalance and inflammation could help explain patterns we see in several diseases.”
The researchers said the findings may help cancer scientists better understand how chromosome instability, loss of gene regulation and cells dividing before they are ready contribute to tumour growth.
They said understanding the normal machinery that prevents these errors may help researchers find ways to push cancer cells into making mistakes they cannot survive.
“We now have a clearer map of the machinery that resets the cell after division,” said Vagnarelli.
“That knowledge gives us a starting point for thinking about new therapeutic approaches.”
After more than a decade of campaigning, doctors around the world have agreed to rename polycystic ovary syndrome (PCOS).
It is hoped the new name, polyendocrine metabolic ovarian syndrome, or PMOS, will help end the misconception that the condition is all about cysts, which campaigners say has contributed to missed diagnoses and inadequate treatment.
The condition affects one in eight women, or 3.1m women and girls in the UK, and is linked to hormone fluctuations that can affect weight, mental health, skin and the reproductive system.
The renaming was spearheaded by UK patient charity Verity alongside Professor Helena Teede, director of Melbourne’s Monash Centre for Health Research and Implementation.
It followed 14 years of consultation with clinicians and patients around the world.
The new name was published in a consensus statement on May 12 and announced at the European Congress of Endocrinology in Prague.
The paper states that PCOS should now be referred to as PMOS.
“This is a landmark moment that will lead to desperately-needed worldwide advancements in clinical practice and research,” said Professor Teede.
“It was heart-breaking to see the delayed diagnosis, limited awareness and inadequate care afforded those affected by this neglected condition.”
When doctors first named PCOS in 1935, they thought it was mainly caused by physical changes to the ovaries.
Decades of research have since changed that understanding, with clinicians now agreeing the condition is far more complex.
“What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” Professor Teede added.
“A name change was the next critical step towards recognition and improvement in the long term impacts of this condition.”
The exact cause of the condition is still unknown, though it is thought to be linked to abnormal hormone levels and is associated with insulin resistance and raised levels of testosterone and luteinising hormone.
Insulin resistance means the body does not respond properly to insulin, the hormone that helps control blood sugar. Luteinising hormone helps regulate ovulation.
Common symptoms listed by the NHS include irregular periods or no periods at all, difficulty getting pregnant, excessive hair growth, weight gain, thinning hair, oily skin and acne.
Campaigners have acknowledged that the name change could cause temporary confusion.
“Despite decades of tireless advocacy to improve awareness, we recognised that the risk of change would be worth the reward,” said Rachel Morman, chairwoman of Verity.
“This shift will reframe the conversation and demand that it is taken as seriously as the long-term, complex health condition it is.”
It is also unclear if, or when, the NHS will change the language it uses.
An NHS England spokesperson said: “We routinely review and update content on the NHS website to ensure it reflects the latest clinical advice and will carefully consider these recommendations.
“The NHS will also continue our work to improve women’s healthcare, including for this important group, which involves giving women more choice over their care, bringing down waiting times, and delivering more care in communities.”
Insight
The RESIL-Card tool launches across Europe to strengthen cardiovascular care preparedness against crises
By Women As One
Women As One is proud to have contributed to the development of the RESIL-Card tool as an active Advisory Board member, ensuring that gender equity and the perspectives of women cardiologists were embedded from the outset.
Through strategic input on the project’s design, formal support of its EU4Health funding application, and ongoing participation in advisory activities, Women As One has helped shape both the direction and implementation of this initiative.
By amplifying awareness, facilitating engagement from our global community, and advocating for inclusive representation, we have worked to ensure that RESIL-Card reflects the diverse realities of cardiovascular care and supports more equitable, resilient health systems in times of crisis. Read more about our involvement here.
On the European Day for Prevention of Cardiovascular Risk (March 14), the RESIL-Card consortium proudly announces the official launch of the RESIL-Card tool, a free online resource designed to help hospital cardiovascular professionals and other stakeholders assess and strengthen the resilience of their care pathways — ensuring that lifesaving care remains accessible even during times of crisis.
Available now at https://www.wecareabouthearts.org/resil-card/online-tool/, the RESIL-Card tool offers a structured self-assessment framework for evaluating the preparedness of cardiovascular services and identifying concrete actions to maintain continuity of care when health systems face disruption.
“Cardiovascular care must remain uninterrupted regardless of the challenges health systems face,” said Professor William Wijns, Research Professor in Interventional Cardiology, University of Galway, Ireland, and We CARE – RESIL-Card Coordinator.
“The RESIL-Card tool provides healthcare teams with a practical way to assess preparedness, identify improvement opportunities, and ultimately ensure that patients continue to receive lifesaving care when it matters most.”
Why the RESIL-Card tool was developed
Cardiovascular diseases remain the leading cause of death in Europe, making the continuity and resilience of care pathways a public health priority.
Despite advances in diagnosis and treatment, recent crises – from pandemics to geopolitical instability – have exposed the vulnerability of healthcare systems.
In today’s increasingly uncertain health landscape and global environment, proactive preparedness is no longer optional – it is essential.
The RESIL-Card tool was developed as part of an EU4Health-funded initiative to support organisations providing lifesaving cardiovascular care in strengthening their preparedness, improving coordination, and safeguarding patient outcomes in times of disruption.
The initiative focuses on practical resilience strategies to help health systems anticipate challenges rather than simply react to them.
“Healthcare systems today operate in an increasingly complex and unpredictable environment,” said Ariadna Sanz, Health Policy Manager at the Catalan Health Service (CatSalut).
“Tools like RESIL-Card help shift the focus from responding to crises toward proactively building strong, adaptable cardiovascular care pathways that protect patients over the long term.”
A collaborative and evidence-based methodology
The RESIL-Card tool is grounded in a robust, multidisciplinary development process involving cardiovascular experts, healthcare professionals, public health specialists, patient organisations, and policy stakeholders from across Europe.
Its development combined comprehensive literature reviews and analysis of existing preparedness frameworks with extensive stakeholder consultations and co-creation workshops. Real-world insights from healthcare providers and patient representatives were integrated throughout the process to ensure the tool reflects the practical realities of cardiovascular care delivery. The methodology also included iterative testing and validation phases, allowing the consortium to refine the tool and ensure it is both scientifically rigorous and practical for everyday use.
“From the outset, RESIL-Card was co-created with clinicians, patient representatives, and health system experts to ensure it reflects real-world practice,” said Professor Niek Klazinga, Em. Professor of Social Medicine, Amsterdam University Medical Centre / University of Amsterdam.
“The result is a tool that combines scientific rigour with practical usability, enabling healthcare teams to translate resilience concepts into concrete action.”
What the RESIL-Card tool is and how it works
The RESIL-Card tool is a practical online self-assessment instrument designed for use by a multistakeholder resilience team led by cardiovascular care providers.
Through a structured four-step process, including a questionnaire and guided analysis, users assess the preparedness and resilience of their cardiovascular care pathways and gain a clear understanding of how well their services can maintain care continuity during periods of disruption.
The assessment process helps teams identify existing strengths as well as potential gaps in service delivery.
Based on the responses provided, the tool offers tailored recommendations and examples of best practices to support improvement.
These insights can then inform strategic planning, helping organisations prioritise actions that reinforce care continuity, strengthen patient safety, and optimise the long-term sustainability of cardiovascular services.
Benefits for Key Stakeholders
For healthcare professionals and organisations delivering cardiovascular care, the RESIL-Card tool provides a structured way to strengthen preparedness and crisis-response capacity.
By helping teams assess their existing systems and identify areas for improvement, the tool supports better coordination across services and clinical disciplines.
It also facilitates evidence-based planning and quality improvement initiatives, enabling healthcare organisations to enhance their operational resilience while maintaining efficient and manageable care processes.
“By promoting awareness about strengths and limitations of each system, the RESIL-Card tool will help physicians to understand where improvements are needed and strengthen coordination and planning to face crises,” said Doctor Alfredo Marchese, Chief of Interventional Cardiology Department at Santa Maria Hospital, Bari, Italy and President of the Italian Society of Interventional Cardiology (GISE).
For patients and patient organisations, the RESIL-Card tool contributes to improving the reliability and continuity of essential cardiovascular care.
By encouraging healthcare providers to proactively address vulnerabilities in care pathways, the tool helps promote uninterrupted access to diagnosis, treatment, and follow-up services.
It also supports a more patient-centred and equitable approach to care delivery, encouraging collaboration and transparency in preparedness planning.
Ultimately, these improvements can contribute to better health outcomes and increased safety for people living with cardiovascular disease.
“For people living with cardiovascular disease, continuity of care is not optional — it is essential,” said Teresa Glynn, Senior Executive Strategy & Partnerships at Global Heart Hub.
“By helping healthcare providers strengthen preparedness, RESIL-Card supports more reliable and equitable access to treatment and greater confidence for patients and their families.”
At the European level, the RESIL-Card initiative contributes to a shared effort to strengthen the resilience of health systems.
By providing a common framework for assessing and improving preparedness, the tool encourages cross-border learning and facilitates the exchange of best practices among healthcare providers and policymakers.
It also aligns closely with European Union priorities on health system preparedness, crisis response, and sustainability.
By helping healthcare organisations identify vulnerabilities and implement practical resilience measures, the RESIL-Card tool can support efforts to reduce inequalities in access to high-quality cardiovascular care across EU Member States.
“Strengthening the resilience of cardiovascular care is a shared European priority,” said Rachel Kenna, Ireland’s Chief Nursing Officer at the Department of Health.
“While the RESIL-Card tool has not yet been tested in an Irish setting we look forward to seeing how it can support the development of more sustainable and prepared healthcare systems.”
Call to Action
Cardiovascular care providers and other healthcare professionals are encouraged to explore the RESIL-Card tool at https://www.wecareabouthearts.org/resil-card/online-tool/.
By using it to assess their cardiovascular care pathways, they will identify areas where resilience can be strengthened and ensure that essential services remain accessible during times of disruption.
Patient organisations also play an important role in this effort. By engaging with healthcare providers and policymakers, they can help promote the use of the tool and ensure that patient perspectives are meaningfully incorporated into preparedness and response planning.
Policymakers and health authorities are invited to support the adoption of the RESIL-Card tool within regional, national and European strategies aimed at strengthening healthcare system resilience.
Integrating the tool into policy frameworks can help safeguard access to essential cardiovascular services and enhance the ability of health systems to respond effectively to future challenges.
Learn more about Women As One at womenasone.org
Entrepreneur4 weeks agoFuture Fertility raises Series A financing to scale AI tools redefining fertility care worldwide
News3 weeks agoWomen’s digital health market set to reach US$5.28 billion in 2026 – report
Diagnosis4 weeks agoNew meta-analysis further supports low re-excisions and high placement accuracy with the Magseed marker
Pregnancy4 weeks agoNIPT or NT scan? Why the 2026 evidence supports doing Both
Mental health4 weeks agoLifting weights shows mental health and cognitive benefits in older women, study finds
Menopause4 weeks agoResistance training has preventative effects in menopause, study finds
Insight3 weeks agoWhy the UK’s fertility rate keeps falling – and what it means if you’re trying now
Wellness3 weeks agoWomen’s HealthX unveils Northwell Health, Corewell Health, Biogen & more to headline Chronic Disease stage
1 Comment