Every year, an estimated 76,000 new cases of bladder cancer are diagnosed among the American population, and a further 16,000 Americans die as a result of the disease, according to the American Bladder Cancer Society.
For the majority of patients who do survive, non-muscle invasive bladder cancer is characterized by a high recurrence rate – approximately 70% – and the requirement for frequent follow-ups, generally involving an unpleasant and costly cystoscopy procedure under sedation or general anesthetic.
For at least the first two years after treatment, follow-ups tend to be scheduled every three months and then less frequently.
Rehovot-based cancer diagnostic company Nucleix, however, is transforming the nature of follow-up monitoring through the development of the Bladder EpiCheck – a urine test for monitoring bladder cancer. It has already received European CE approval, increasing support from the scientific and medical communities and became standard of care in a leading Netherlands hospital.
“Nucleix looks for fragments of DNA that are shed from tumors, and uses them to identify where they are coming from, and whether they are cancerous or not,” Nucleix CEO Dr. Opher Shapira told The Jerusalem Post.
“In every body liquid, there are always some fragments of DNA coming from the body’s cells. It’s a platform technology applicable to any type of disease that causes epigenetic changes. Cancer is making a lot of alterations.”
Clinically validated in several independent studies in leading hospitals and labs throughout Europe, the Bladder EpiCheck has shown best performance of a noninvasive tool in detection of bladder cancer recurrence in clinical trials when compared to the usual, invasive standard of care. The test is currently undergoing clinical trials in the US toward submission to the Food and Drug Administration.
The test is objective, operator-independent and requires standard laboratory equipment. It is based on identification and analysis of subtle changes in DNA methylation patterns, which represent a powerful tool for distinguishing between cancer and healthy cells and, accordingly, for detection of tumors in the body.
“The best feature of our test is its ‘negative predictive value,’” said Shapira. “If we say that the patient is negative, what’s the likelihood that he doesn’t have cancer? We have shown that if we say negative, it’s more than 99% accurate that the person doesn’t have high-grade bladder cancer.”
Considering that approximately 90% of follow-up cystoscopies are negative, patients often find themselves needlessly traveling long distances to the hospital and undergoing invasive procedures. Many patients are also lost to follow-ups, in which they fail to attend or schedule repeat appointments.
Nucleix’s urine samples can be collected from the patient’s home, however, thereby avoiding the inconvenience of regularly attending hospital appointments and reducing the costly impact of tests on the healthcare system. If the result of Nucleix’s urine test is negative, the patient will not have to visit the hospital for a follow-up meeting approximately 85% of the time.
“Compliance is an issue, especially as an older-age disease with associated comorbidities, because patients go into hospital every three months to do a cystoscopy, and it might be repeatedly negative,” Nucleix vice-president Dr. Aharona Shuali told the Post.
“Many patients will say there’s nothing and won’t come again. They can then miss the recurrence of a high-grade tumor and be at risk of invasive and lethal cancer. The Bladder EpiCheck could drive compliance.”
Last month, Radboud University Medical Center in Nijmegen, the Netherlands, chose to add the Bladder EpiCheck to its standard of care for bladder cancer recurrence detection, collecting urine samples from the patients’ homes.
On Thursday, Bladder EpiCheck received further endorsement with the publication of an analysis in the BJU International medical journal by Prof. Shahrokh F. Shariat, the head of the department of urology at the Medical University of Vienna.
“Our analysis demonstrated that adding Bladder EpiCheck to patient information significantly improves the accuracy of predicting the presence of high-grade cancer from 72.7% to 94.9%,” said Shariat.
“Such high predictive accuracy allows physicians to use Bladder EpiCheck as a rule-out test, to properly select high-risk patients for invasive cystoscopy and reduce 80% of cystoscopies without missing a single high-grade cancer.”
Based on the same platform technology, Nucleix is now developing Lung EpiCheck, a diagnostic blood test for the early detection of lung cancer. The company has received €2.5 million ($2.8m.) in funding from the EU’s Horizon 2020 program for its development.
A clinical study based on blood samples collected from 20 centers and three biobanks in Europe and Israel last year produced what the company describes as the best clinical results for such a test to date.
“Everyone knows lung cancer is a big issue and everyone is trying to find a solution for early detection but, as far as we know, we have shown the best results,” said Shapira.
“Our target is to launch a large-scale clinical trial worldwide – in Europe, US and China – and to substantiate the results with a large number of cases. We hope to launch the trial in the coming months,” Shapira added.
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