Entrepreneur
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
By Women’s Health Week
With four weeks to go until Women’s Health Week USA, the excitement is ramping up!
The final early bird pricing closes this Friday, the full speaker lineup is confirmed, and a record number of pitch applications signals the depth of innovation now moving through the sector as we enter the Era of Scale.
Women’s Health Week USA takes place May 13-14 at the New York Academy of Medicine in New York City, bringing together 600+ senior decision makers spanning investors, founders, multinationals, payers, providers and policymakers around one shared agenda: taking women’s health from growth to scale.
Early bird tickets are available until midnight on Friday, April 17.
Book by then to save up to $600 on your place
The Full Speaker Lineup is Confirmed
The full speaker lineup has finally been confirmed, with 80+ voices spanning investment, innovation, policy, medtech and pharma.
The programme reflects the event’s 2026 theme, The Era of Scale, moving beyond early validation into the harder work of institutionalising women’s health as a category.
Confirmed speakers include Kate Ryder (Maven Clinic), Mallika Mundkur (FDA), Melanie Newman (Planned Parenthood), Nichole Young-Lin (Google), Jill Angelo (OURA), David Stern (Kindbody) and Tammy Sun (Carrot Fertility), alongside representation from the NYSE, ARPA-H, the World Health Organization, Samsung Next, Novo Holdings and more.
170 Pitch Applications and Counting
The Women’s Health Week USA Innovation Showcase received a record 170 applications ahead of its April 10 close, the highest number in the event’s history.
The volume reflects the growing depth of innovation in the sector, but it was the quality of submissions that stood out, with companies across Medical Devices & Therapeutics and Consumer & Tech bringing genuinely differentiated solutions to conditions that have been underserved for decades.
The selected companies will get the chance to pitch on the mainstage at the New York Academy of Medicine in front of the full audience of 600+ investors, corporates, innovators and strategic partners.
Results will be announced next week.
Register your interest to find out who makes the WHW USA Innovator Class of 2026
NYSE Partnership: A Quick Recap
For those who missed our announcement on Femtech World last week, the New York Stock Exchange is the Official Exchange Partner of Women’s Health Week USA 2026.
On the morning of May 13, WHW will feature in the NYSE Market Update, reaching approximately 200 million viewers.
Women’s Health Week will also light up the North Star Billboard in Times Square for a full week around the event, with live and taped interviews distributed across NYSE Live and Taking Stock.
It remains one of the most significant institutional endorsements the women’s health sector has seen.
Early Bird Pricing Closes This Friday
Tickets increase by up to $600 after midnight on Friday, April 17. For anyone with May 13-14 in their calendar, this week is the window to move.
Flora Fertility has raised US$5m in seed funding to roll out fertility insurance across the US, with plans to expand into Canada.
The round was led by ManchesterStory, with participation from Slauson & Co., TruStage Ventures, BDC Capital, Marathon Fund, Adara Venture Capital and strategic angel investors. Existing investors include Highline Beta, Everywhere Ventures and Cartography Capital.
Laura McDonald, co-founder of Flora Fertility, said: “Fertility is one of the largest uninsured financial risks people face, yet the system today only offers support once you’re already in crisis and often only if your employer provides it.
“We’re creating a new category where fertility becomes something you can proactively plan for, not just pay for when it’s too late.”
Flora says it is introducing a new InsurTech category with individually owned, portable fertility insurance designed to address a gap in healthcare cover.
The company says it wants to shift fertility from a reactive expense to a proactive, data-driven financial planning tool, using AI, personalised underwriting and risk modelling.
The platform lets people buy coverage without relying on an employer, helping it continue through job changes and different stages of life.
Flora’s policies cover a full range of fertility treatments, including diagnostics, medications, intrauterine insemination and in vitro fertilisation, with entry-level pricing starting at about US$20 a month.
The company estimates that infertility affects one in six people globally, while treatment costs can range from US$30,000 to US$50,000, leaving the vast majority of patients without access to care.
Flora says its platform currently reaches more than 10 million prospective policyholders across North America.
The funding will be used to expand Flora’s underwriting capabilities, scale distribution and further develop its platform as it seeks to establish a new market within women’s health and insurance.
Nicole Gunderson, partner at ManchesterStory, said: “Flora is building something that has never existed before, affordable, portable fertility insurance that meets the next generation of women exactly where they are.
“The InsurTech opportunity here is enormous, and the Flora team has the expertise, technology, and vision to define this category.”
Dr Christy Lane, co-founder of Flora Fertility, added: “Fertility has always been treated as unpredictable and uninsurable, but the data tells a different story.
“The earlier someone can access that coverage, the better their outcomes and the lower their costs, which is what makes this model so powerful.
“We’re turning fertility from a reactive medical expense into a proactive, data-driven financial decision.”
By Women’s Health Week
When the New York Stock Exchange signs on as the Official Exchange Partner of a women’s health event, it’s worth paying attention to.
Women’s Health Week USA, taking place May 13-14 at the New York Academy of Medicine in New York City, has confirmed the NYSE as its Official Exchange Partner for 2026.
It is one of the most significant institutional endorsements the women’s health sector has seen, and it says something meaningful about where global capital markets are directing their attention.
Find out more about WHW USA 2026 here.
What the Partnership Involves
This is not simply a logo on a lanyard.
The NYSE partnership comes with a set of activations that put women’s health in front of audiences well beyond the event itself.
On the morning of May 13, Women’s Health Week will be featured in the NYSE Market Update, reaching an audience of approximately 200 million viewers across outlets including Yahoo Finance and the Financial Times.
For a sector that has historically struggled for mainstream financial visibility, that kind of reach is significant.
Women’s Health Week will also light up the North Star Billboard in Times Square for a full week around the event, placing the brand at the centre of one of the most commercially visible locations in the world.
NYSE will produce live and taped interviews with WHW leadership and keynote speakers, distributed across NYSE Live, Taking Stock, and partner platforms reaching tens of millions of viewers monthly.
A dedicated NYSE content team will be on the ground at the New York Academy of Medicine capturing the conversations and connections taking place across both days.
The NYSE’s Healthcare & Life Sciences team will also take to the stage at Women’s Health Week USA, sharing their perspective on trends shaping the sector from a capital markets standpoint.
Why It Matters
The partnership is a signal as much as it is a sponsorship.
Women’s health has spent years making the case that it is a commercially serious category.
The NYSE’s involvement makes that case in a language the broader financial world understands.
Women’s Health Week USA 2026 is themed around The Era of Scale, a deliberate framing around the idea that the sector has moved beyond early validation into the harder work of institutionalisation.
Capital is moving. M&A activity is increasing. Generalist investors are entering a space that was once left to specialists. The NYSE partnership fits neatly into that narrative.
With 600+ senior decision makers confirmed across investors, founders, multinationals, payers and policymakers, the event is already one of the most commercially concentrated gatherings in the women’s health calendar.
The NYSE’s reach extends that concentration well beyond the walls of the New York Academy of Medicine.
Find out for yourself why this partnership is so perfect and join Women’s Health Week USA. Secure your ticket here.
The Pitch Sessions
For founders and early-stage companies, Women’s Health Week USA also hosts a mainstage Pitch Session across two categories: Medical Devices & Therapeutics and Consumer & Tech. Fifteen companies will be selected to pitch in front of the full audience.
Applications close April 10.
They are free to submit, and any company working on a condition that affects women exclusively, differently, or disproportionately is eligible.
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