Liquid biopsy tests may enhance bladder cancer detection

In this interview, Dave Mori discusses the Oncuria bladder cancer tests. Mori is the Chief Business Officer at Nonagen Biosciences.

"This year, we're looking to start broadly increasing the sale of the tests," says Dave Mori.

Could you provide a brief overview of the Oncuria bladder tests?

At Nonagen, we've developed the liquid biopsy test called Oncuria. The test itself can be used on 3 different indications. The first would be Oncuria-Monitor, which is used to detect recurrence of cancer in patients that are undergoing surveillance of bladder cancer. That same test with a different algorithm can be used for detecting patients that are presenting with hematuria, both gross and microscopic hematuria. That's called Oncuria-Detect. Then the third is for predicting the rapid failure of BCG. We call that Oncuria-Predict.

The test itself is quite unique in the fact that it's not just testing for a single protein. It's actually testing on 10 separate proteins in a single multiplex immunoassay. Because of that, it increases the sensitivity and specificity, but it also increases the ability for us to use that single test across multiple indications.

How might this test fit into the bladder cancer treatment paradigm?

What we're looking to supplant is urine cytology. It's been used since the 1940s, but it's highly inaccurate at a sensitivity of approximately 35%. I think urologists are probably frustrated with the low accuracy rate of that test. So, we're looking to replace urine cytology with a test that is robust in detecting and predicting in the case of rapid failure for BCG.

The test itself is on a very commonly used platform called the Luminex platform. So, it's widely used and widely understood. From a usage perspective, it's going to be very easy for urologists or even for labs to transition from urine cytology over to using Oncuria because it's the same practice. It's just a simple urine collection, but a much smaller amount. We need only a fraction of what you would need for doing urine cytology in terms of the actual amount of urine to process the test. Then the physician would ask the patient to submit their sample, that sample would then be sent to our laboratory, it would go through for processing the test, very quickly, we would send back a report to the prescribing physician, the physician would then inform the patient, and then they'd be able to make a clinical decision based on that.

Could you discuss some of the data that has been shared on these tests?

We have a lot of data published. We have over 30 different publications. From a sensitivity and specificity perspective, all of our indications are varying anywhere from 80% to, in some cases, low 90% in terms of sensitivity and specificity. So, it's a big difference compared with urine cytology, which I mentioned is at 35%.

What are the next steps for this test?

This year will be very exciting for us. We just got CMS [Centers for Medicare & Medicaid Services] coverage for the test.¹ So, all 3 of the different indications were all given their own Proprietary Laboratory Analyses (PLA, or Current Procedural Terminology) codes, and Medicare is now reimbursing for it.

This year, we're looking to start broadly increasing the sale of the tests. Our partner for distribution of the test is DiaCarta. They're a molecular diagnostics laboratory based out of California. We are also close to being able to announce a partnership with one of the largest CLIA labs in the country that will offer our suite of tests.I mentioned we have the Oncuria-Monitor, Oncuria-Detect, and Oncuria-Predict. We hope to have another indication launching later this year as well for Oncuria-Detect.

[Also] later this year, if all is going well in terms of funding for our company, we're going to hopefully submit our first marketing application to the FDA on Oncuria-Monitor, so these are exciting times.

Reference

1. Nonagen receives Medicare payment rate for the Oncuria bladder cancer tests. News release. Nonagen Biosciences. January 10, 2024. Accessed March 11, 2024. https://www.nonagen.com/news-briefs