Hitting the right targets: DNA test reveals if cancer patients will respond to chemotherapy treatments

It is almost a flip of a coin whether pancreatic cancer patients respond to the standard chemotherapy drug, FOLFIRINOX. As a solution to oncologists apprehensively giving patients one of the toughest chemotherapy treatments out there, Dutch bioinformatics company, Omnigen, is developing a clinical decision support system based on a DNA test that shows a patient’s responsiveness to FOLFIRINOX treatment with an initial accuracy rate of 93%.

Omnigen’s accurate clinical decision support system for personalising cancer treatments

Chemotherapy has devastating effects on a person’s body; 5% of cancer patients die from treatment side effects. This statistic is made even worse with the knowledge that 45% of pancreatic cancer patients do not respond to FOLFIRINOX, the first-line chemotherapy drug for the disease.

Founder and CEO of Omnigen, Berry Kriesels, wants to spare cancer patients from enduring chemotherapy treatments that are largely ineffective because of their genetic makeup. The company chose to tackle pancreatic cancer first; a disease with one of the worst life expectancies of any cancer, with only 6% of patients surviving beyond five years.

After some years of research, Omnigen’s diagnostic clinical decision support system is now at a stage where it can determine whether the chemotherapy drug FOLFIRINOX will be effective at stabilising or reducing tumour size in individual pancreatic cancer patients. Kriesels explains, “Already, it seems we can say with 99% certainty whether someone with pancreatic cancer will be a responder or non-responder to FOLFIRINOX – the wrecking ball of chemotherapy drugs.”

Omnigen’s clinical decision support system began in an international R&D project with Noray Bioinformatics in Spain and the Erasmus Medical Centre in the Netherlands. Together, the project partners validated analyses, including data from 200 patients, and Omnigen will test a further 600 in more clinical trials. As time progresses, Kriesels hopes to further validate the accuracy rate of 99%, which is significantly higher than similar tests already on the market for other types of chemotherapy.

Exploring alternative cancer treatment plans

Although it may sound bleak to discover your body will not respond well enough to the main chemotherapy treatment for pancreatic cancer, it opens the door for other options, like Gemcitabine chemotherapy, clinical trials or palliative patient care, morphine and spending time with loved ones. Kriesels says, “In the end, our hope is that if you do not treat pancreatic cancer with something you know in advance will not help, the chances of surviving and passing the five-year threshold will be greater.”

“If we can only make sure one cancer patient does not have to suffer – and we help them receive treatment that does work for them thanks to our service – that is enough for me.” – Kriesels

As well as reducing human suffering, uptake of Omnigen’s clinical decision support system would have a significant effect on societal cost saving. FOLFIRINOX chemotherapy treatment costs roughly 60,000 euro per patient, so if we know in advance which 45% of pancreatic cancer patients will be unresponsive to the chemotherapy drug, resources can go into paying for development of other more effective treatments instead. Omnigen will market their clinical decision support system at 1,500 to 2,000 euro per analysis.

Omnigen 1.png

Deciding on cancer treatments with DNA data and AI

“What is common in cancer research is taking a biopsy of the tumour, running genome sequencing of the cancer tissue DNA and then looking at differences between the cancers. We turned this method around.” – Kriesels

So, how does Omnigen perform its analysis and what exactly is tested? Kriesels explains, “instead of analysing the tumour, we started screening pancreatic cancer patients themselves on different types of biomarkers: microbiome, RNA expression and DNA.”

With this data, Kriesels and the team assessed which genomes determined a patient’s responsiveness. They broke down information extracted from the DNA samples to find biomarkers that could identify the responders and non-responders. By using a combination of classic statistical approaches, machine learning and layers of artificial intelligence (AI), Omnigen is on its way to developing a clinical decision support system with an astounding accuracy rate.

The results are so accurate that Kriesels thought they could be a misreading at first. He describes enriching the data outputs with AI layers like being able to see with more clarity, and says, “It started making sense – so much sense that it was too much of a coincidence to be a coincidence.”

Omnigen 3.JPG

Building immunity: international expansion and other types of cancer

Omnigen already has expertise working with DNA and AI. Founded in 2015, the company also offers DNA-based advice to consumers (on nutrition, sports, sleep, stress and skin ageing) and uses Fitbit data and AI in one of their running projects in collaboration with a public hospital to assess cardiovascular patients.

Kriesels is happy with the direction Omnigen is moving in; the team have several ongoing projects related to personalised treatment and disease prevention. Omnigen’s clinical decision support system for pancreatic cancer patients receiving FOLFIRINOX chemotherapy will be on the market and helping patients from 2025. In tandem, Omnigen is researching the responsiveness of liver cancer patients to another chemotherapy drug, Sorafenib.

Participating in an international R&D project and receiving public funding gave Omnigen a taste for international expansion. With a strong foothold in the Benelux region (through the Erasmus Medical Centre and Antwerp University hospital), Omnigen is now looking further afield to new markets. Kriesels describes plans to continue expanding in Europe, but also to open a subsidiary branch of Omnigen in the United States and make the most of harmonised food and drug administration (FDA) regulations.

“Collaborating with different partners gave us a lot of knowledge about the healthcare system, patient confidentiality and GDPR in Spain. I did not anticipate this beforehand.” – Kriesels

The hope is that oncologists and cancer treatment centres will recognise the value of Omnigen’s clinical decision support system for cancer patients. With widespread use of the clinical decision support system, we can more successfully improve patient care, reduce societal healthcare costs and indirectly increase life expectancy: early on in the first-line treatment, we will know if a chemotherapy drug will help or not and be able to provide personalised treatment plans.