The study is called AURORAX-0087A, that’s the long name of it, we just call it AUR-87. What it’s about is a diagnostic test using a urine test to measure something called glycosaminoglycans, GAGs for short. Then if you look at different profiles of GAGs, which are long sugar chains you might say, or disaccharides, polydisaccharides, we measure the profiles of those in urine to see if we can detect a recurrence from clear cell renal cancer.

The way we do the measurement is that it’s a mass spectrometry machine that measures the different profiles of different GAGomes and that’s then calculated into a GAGome score. That GAGome score, the intention of the study was to determine whether the GAGome score could give us a new diagnostic tool to detect recurrence after curative intent surgery for clear cell RCC.

The way the study was set up was that we had a prospective multi-centre study with a two-step design, meaning that we had one cohort to develop the GAGome score test and then a second cohort is intended to validate our initial findings. So identical cohorts, identical set-up of the studies, but what is being presented is the cohort 1 data that came out now. What we did was that we followed patients who had had curative intent surgery for clear cell RCC specifically. With curative intent we mean, of course, either partial or radical nephrectomy. If the patient was without any signs of disease at our final eligibility assessment they were included in the study where they were followed with the regular standard of care imaging as their surveillance protocol and alongside that we took on a regular basis urine samples to measure the GAGomes and then calculate the GAGome score.

The study started in January 2020 and the last patient visit was in 2023. We then analysed the data and in the 134 patients that were enrolled in the study we could see that about 15-16% had a recurrence. When we looked at the diagnostic accuracy of the GAGome score to detect a recurrence, compared to the reference standard which was imaging, we found that the sensitivity for GAGome score is 90% and the specificity is 51%. That gives a negative predictive value of 97% to rule out a recurrence using this urine test. It gives a positive predictive value of 26%. So this test was really good at ruling out cancer but moderate to rule in or detect a cancer.

What we also showed that for every ten points on the GAGome score, which is a calculated score of between 0 and 100, if you put the threshold at 12 points, that was the optimised cut-off point for getting the sensitivity and specificity data just provided, at that point for every ten-point increase above that the risk of having a recurrence went up with 63%.

Lastly we also saw that if you compared the GAGome score as a method of detecting recurrence to the standard of reference imaging, the lead time was four months, meaning that at the median level the GAGome score could detect recurrence four months earlier than radiological recurrence.

So the conclusions of the study are that the test has a high sensitivity but a moderate specificity and that translates into that you can use the test to rule out cancer and if you look at the lead time you can actually then conclude that clinically you could omit half of the CT scans that are being performed today. So that would reduce costs for the healthcare systems, it would reduce anxiety for the patients having to do frequent scans and it would allow earlier recurrence detection potentially. The limitations of the study were that the follow-up was only 18 months so that might have biased the specificity and also the lead time.

Lastly, as a next step, we are going to perform the analysis of cohort 2 where the patient enrolment and the last patient visit was going to be towards the end of this spring of 2025. We’ll hopefully have an external validation dataset to confirm our findings in about a year from now.

The GAGome test and the company that has developed it, the sponsors of the study, they have not received regulatory approval for the test so it’s not on the market yet. But they aim to have it on the market in 2026.