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Cancer

Ending the guesswork in cancer care: A CEO’s vision for predictive precision oncology

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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

Insight

GSK ovarian and womb cancer drug shows promise in early trial

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GSK said its ovarian cancer drug shrank or cleared tumours in more than 60 per cent of patients in an early trial as CCO Luke Miels pushes faster development.

The company said that in an early-stage trial, Mocertatug Rezetecan, known as Mo-Rez, shrank or eliminated tumours in 62 per cent of patients with ovarian cancer after chemotherapy had failed, and in 67 per cent of those with endometrial cancer.

Hesham Abdullah, GSK’s global head of cancer research and development, said: “Treatment of gynaecological cancers remains a major challenge, with a pressing need for new therapies that offer improved response rates.

“With Mo-Rez we now have compelling evidence of a promising clinical profile.”

GSK acquired the Mo-Rez treatment, an antibody-drug conjugate, from China’s Hansoh Pharma in late 2023 and has trialled it in 224 patients around the world, including the UK, over the past year.

Only a few patients needed to stop treatment because of side effects, the most common being nausea.

It is given every three weeks by intravenous infusion, meaning directly into a vein.

Combined with data from a separate intermediate trial in China, the results have given the British drugmaker the confidence to go straight to late-stage trials, with five clinical studies planned globally in the next few months, including on patients in the UK.

Speaking to journalists before the conference, Abdullah described Mo-Rez as a “key asset” in the company’s growing cancer portfolio.

It is expected to be a blockbuster drug, with peak annual sales of more than £2bn, which GSK hopes will help it achieve its 2031 sales target of £40bn.

A few years ago GSK did not have any cancer drugs on the market, but it now has four approved medicines and 13 in clinical development.

Last year, oncology generated nearly £2bn in sales, up 43 per cent from 2024, with sales of its endometrial cancer drug Jemperli rising 89 per cent.

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Diagnosis

Smear test: Everything you need to know before your appointment

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Article produced in association with Spital Clinic

Cervical screening saves thousands of lives from cervical cancer in the UK every year.

The programme has changed significantly in recent years, and understanding what it now involves — and what your results actually mean — is probably the most useful preparation you can do before your appointment.

Why Cervical Screening Exists — and What Changed in 2025

The NHS cervical screening programme now uses HPV primary screening — a method NHS England describes as testing for the human papillomavirus (HPV) rather than looking directly for abnormal cells.

If HPV is not found, the sample is not examined further; if HPV is found, the same sample is then checked for cell changes.

The reason HPV sits at the centre of this approach is straightforward. Nearly all cervical cancers are caused by certain high-risk types of HPV — and HPV is extremely common.

Most people encounter some form of it during their lives, and the body usually clears it without any treatment.

The problem arises when high-risk HPV persists, because over time it can cause cell changes in the cervix that, if left undetected, may eventually develop into cancer.

Cervical screening is therefore a prevention test, not a cancer diagnosis. Its purpose is to find those cell changes early, when treatment is straightforward and effective.

A significant change took effect in England on 1 July 2025.

The screening interval for those aged 25–49 was extended from three years to five years, in line with the 50–64 age group — so everyone aged 25 to 64 in England is now invited every five years.

The interval in Northern Ireland currently differs; Cancer Research UK has current details.

Who Is Invited and How to Book

NHS England invites everyone with a cervix aged 25 to 64, with the first letter usually arriving a few months before a person’s 25th birthday.

Invitations are sent automatically and are linked to GP registration — the simplest way to make sure yours arrives is to be registered with a GP and keep your contact details up to date. If your invitation hasn’t come through, any GP surgery can arrange an appointment.

Trans men and non-binary people registered as female with their GP will receive invitations automatically.

Those registered as male will not — but can self-refer through the NHS cervical screening programme website or ask their GP to arrange a test.

People over 65 are not routinely invited but are not excluded.

Anyone who has never been screened, or whose most recent result was abnormal, can request screening through their GP or a clinic.

Appointments are most commonly offered at GP surgeries, carried out by a nurse or doctor.

For those who prefer a different setting, shorter waits, or an appointment outside NHS hours, a private smear test can be arranged through specialist gynaecology clinics, often within a few days.

What Happens at a Smear Test Appointment

The test itself takes less than five minutes, with the full appointment lasting around ten minutes.

Knowing what happens — step by step — removes most of the uncertainty that makes it feel more daunting than it actually is.

You undress from the waist down and lie on an examination table, knees bent and falling gently apart.

The nurse or doctor applies a little lubricant and gently inserts a small speculum, which is opened just enough to make the cervix visible.

A small, soft brush sweeps a cell sample from the surface of the cervix. The speculum is removed, and you get dressed.

That is the entirety of the test.

A little preparation helps both comfort and sample quality.

Avoid vaginal medicines, lubricants, and creams for at least two days beforehand, as residue can interfere with the results. Avoid scheduling during your period for the same reason.

Loose-fitting clothing — a skirt or wide-leg trousers — makes undressing and repositioning much easier.

If you are going through the menopause, vaginal dryness can make speculum insertion uncomfortable.

Cancer Research UK notes that using a short course of oestrogen cream or pessaries for around two weeks beforehand can help considerably — though stop two days before the appointment to avoid affecting the sample.

It is worth mentioning to your GP when you book.

Most people feel some pressure or mild discomfort, but it does not usually hurt.

If you find it painful, you can ask for a smaller speculum, insert it yourself, or try lying on your side — all are standard adjustments. Light spotting afterwards is normal and usually clears within a few hours. You can ask to stop at any point.

Understanding Your Results

The most common result — received by 87 in every 100 people screened — is HPV not found.

That means no high-risk HPV was detected, your risk of developing cervical cancer before the next screen is very low, and nothing further is needed until your next invitation arrives in five years.

The other results fall into two categories. Nine in every 100 people are told HPV was found, but no cell changes were detected.

This is not a cancer result and does not require immediate treatment — it means high-risk HPV is present and the cervix is being monitored.

The pathway is a repeat screen at one year; if HPV is still present, another repeat at two years. Only if it persists at that point is a colposcopy referral made.

Four in every 100 people receive an HPV-positive result alongside detected cell changes, and are referred directly for colposcopy.

That referral is not a diagnosis of cancer.

A colposcopy is a closer examination of the cervix, carried out in a clinic using a magnifying device, allowing a clinician to look in detail at any flagged cell changes.

Most people who attend colposcopy do not have cervical cancer — NHS England is clear on this. If a biopsy is taken or cells are removed, there is a small risk of bleeding and infection, both well-managed.

Those who prefer not to wait for an NHS appointment can access a private colposcopy at specialist clinics.

Results usually arrive by post or through the NHS App within two to six weeks. Samples are kept for ten years.

HPV can remain in the body for many years without symptoms, so a positive result says nothing about recent exposure or transmission history.

HPV, the Vaccine, and When to See a GP Without Waiting

Nearly all cases of cervical cancer are linked to high-risk HPV.

The virus spreads through skin-to-skin genital contact, vaginal, anal or oral sex, and sharing sex toys — it does not require penetrative sex to pass between people. The vast majority of people who carry it clear it naturally and will never know they had it.

The UK’s HPV vaccination programme, which began in 2008, has meaningfully reduced risk in younger age groups.

But vaccinated people still need to attend cervical screening — the vaccine does not protect against all high-risk HPV types. Vaccination and screening work together; one does not replace the other.

Cervical screening runs on a schedule, but some symptoms need attention straight away — do not wait for your routine invitation.

According to NHS England, these include unusual vaginal bleeding, bleeding after sex, bleeding during or after the menopause, heavier periods than usual, changes in vaginal discharge, pain during sex, or persistent lower back or pelvic pain.

These symptoms do not confirm anything, but they need investigating without delay.

Attending every invitation remains the single most important thing anyone in the eligible age group can do — and with the 2025 extension to five-year intervals, each appointment now covers a longer window than it once did.

The extension of the English screening interval to five years is backed by strong evidence about the accuracy of HPV primary screening.

Simply turning up remains, by some margin, the most protective thing anyone in the eligible age group can do.

This article is for informational purposes only and does not constitute medical advice. For personal health concerns, consult a qualified healthcare professional. Cervical screening eligibility and intervals may vary; refer to current NHS guidance or your GP for the most up-to-date information applicable to your circumstances. This piece was produced in association with Spital Clinic, which provided background clinical information for editorial purposes. Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.

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Diagnosis

Proseek Bio raises AU$1.5m for ovarian cancer blood test

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Australian startup Proseek Bio has raised AU$1.5m in an oversubscribed seed round to commercialise its ovarian cancer blood test.

With up to 80 per cent of surgeries for suspected ovarian cancer coming back benign, the company says better diagnostics are urgently needed.

Proseek Bio says its test is designed to support earlier and more precise clinical decision-making, while improving referral pathways and reducing unnecessary surgery.

OC-Triage is a blood-test-based ovarian cancer detection test that identifies specific glycoproteins, which are proteins that can indicate a future likelihood of ovarian cancer.

Proseek Bio says it could change how women are triaged for diagnostic surgery.

Founded by Michelle Hill, Proseek Bio says it has future applications beyond ovarian cancer, including endometriosis triage and other women’s health diagnostics.

The company said in a statement: “This funding will support the next stage of development for OC-Triage, our blood-based test for ovarian cancer, as we move toward clinical lab deployment and validation.”

Proseek Bio says women’s health has long been framed as “niche” or an “impact category” but says it is in fact one of the most mispriced opportunities in healthcare.

Ovarian cancer is one of the most lethal gynaecological cancers and more than 15,000 women in Australia undergo diagnostic surgery for ovarian cancer each year, with many cases diagnosed too late.

The five-year survival rate for ovarian cancer today is the same as the five-year survival rate for all cancers in 1975.

“We’re now seeing that shift: capital is beginning to catch up to the scale of both the clinical need and the commercial potential,” the company said.

“OC-Triage is designed to support earlier and more precise clinical decision-making, improving referral pathways and reducing unnecessary or delayed surgery.”

Proseek Bio says it is now preparing to pursue a Series A raise focused on market entry, clinical studies and regulatory progression.

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