Please can you give a brief introduction to bladder cancer and how it is currently detected?
Bladder cancer is the seventh leading cancer affecting men worldwide and in the United States, it is the fourth leading cancer. Each year, about 350,000 cases are being detected worldwide, and the disease claims 165,000 lives every year.
It has one of the highest recurrence rates and is one of the most expensive cancers to treat, especially since its recurrence rate is so high (reaching around 80%).
Today, there is no approved screening test for bladder cancer and only selected patients and those who have had bladder cancer in the past are tested.
The gold standard for detection is cystoscopy, which is an invasive procedure that's very expensive, very uncomfortable and not easy to perform.
Patients who have recovered from bladder cancer are asked to perform this invasive test four times a year for the first couple of years after their recovery, followed by twice a year after this period and then they attend once a year.
There are several non-invasive tests available but they are not widely used for two reasons. One, because they are either not sensitive or specific enough and two, because the tests that are more sensitive and specific are very expensive and difficult to perform.
This means there is an unmet need for simple, easy-to-use, inexpensive tests to help in the monitoring of the bladder cancer population and an even greater need for robust tests to screen and diagnose new cases.
What prompted Micromedic Technologies to start developing a non-invasive test for detecting bladder cancer in urine?
Micromedic, a subsidiary of BioLight, owns the IP for a platform technology called CellDetect, which has unique staining capabilities. It can actually color-differentiate between pre-cancer cells, cancer cells and normal cells.
This technology has already been approved in Europe, Israel, and China for the detection of cervical cancer, but it can actually be used for different types of cancer, using different types of samples.
The company started with cervical cancer, where there is another huge and unmet need for screening (specifically in developing markets). Given a significant unmet need in bladder cancer worldwide, and the fact that the FDA announced that screening and monitoring for bladder cancer is something they're looking for, we decided to make this cancer the next indication as we have the ability to bring such a test to the market in the relatively short term.
Please can you tell us a little bit more about the CellDetect technology?
It is a powerful oncology histochemical platform that has multiple applications. It's the only assay we know about worldwide that provides color discrimination between normal and neoplastic cells, as well as enabling morphological examination.
What is very unique about our IP is that we're actually utilizing standard processes that any pathology lab will use and making no changes to the way a sample is taken, the way lab equipment is used or the way a pathologist needs to analyses a slide. We are simply making the entire diagnostic process much simpler, faster and accurate.
At what stage of development is CellDetect currently at?
The first indication for CellDetect was identifying cervical cancer in smears. This was already approved in Europe, Israel, and China and we are in the first stages of commercializing this indication in China and India.
The reason that we have targeted these markets with CellDetect tests for cervical cancer is that there is a huge need for these kits in these countries, which currently make up 25% of cervical cancer mortality cases globally.
When you look at developed countries in the U.S. and in Europe, you will see that several ways of detecting cervical cancer are available to women such as pap smears and the HPV test. However, when we look at the developing countries, women do not always have access to these tests and more and more women are actually dying from the disease. Therefore, the first goal is to target developing countries.
As I mentioned, the second indication is bladder cancer and we have recently published results from our multicenter clinical trial that we are very happy about because we believe they set a new level of sensitivity and specificity compared to other tests and are sufficient to get us through CE approval. We are also planning to submit the results to the FDA and start discussing with them what would be the regulatory pathways for approval.
In Europe, we do believe that, based on these regulatory pathways, we will be able to commercialize the product by the end of this year.
Regarding the U.S, we still have to discuss with the FDA their regulatory program, but under the estimation of 510(k) regulatory pathway, the trials are not very complicated to perform because patients who have recovered from bladder cancer have to return to clinics for monitoring anyway. Once they return to the clinics, they provide a urine test, which would make such a trial very easy to perform.
How does the CellDetect urine test compare to traditional methods of bladder cancer detection?
First of all, the gold standard test – cystoscopy - is invasive and expensive due to the amount of tests needed to monitor recovered patients. This means non-invasive, inexpensive and easy-to-perform tests are required for monitoring these patients.
Several non-invasive tests are available at the moment. However, they are either relatively low-cost and easy to perform but have a very low sensitivity and specificity or they are more specific and sensitive, but very expensive and complicated to use. Furthermore, most of these tests do not identify cancer in the early or low grade stage.
We believe that we are introducing a simple test that is not expensive, is very easy to perform and does not require much procedural change. It also has the potential to detect the recurrence of bladder cancer in the very early stages, which is extremely useful because then you can treat the cancer sooner.
What do you think the future holds for bladder cancer diagnostics?
We are excited about our test because we do believe it has a huge potential, not only for monitoring bladder cancer patients, but also in helping doctors to detect the cancer in patients who are presenting with blood in their urine or other symptoms.
We believe that a very simple test like this one could also be introduced as a screening test. We are not going down this screening pathway at the moment, as we are targeting the monitoring of recurring bladder cancer, but we already have plans in place to expand indications.
So I do believe that by having a non-invasive test which is easy to use and inexpensive, there will be a great opportunity to identify this cancer in the early stages and stop it from being a disease that leads to 165,000 deaths per year.
Do you think the CellDetect technology has the potential to diagnose additional cancer indications?
Absolutely. We already have initial small-scale clinical tests that we perform on different cancer types and different samples. As well as using the test to check urine and pap smear samples, we also have the ability to detect cancer cells in blood and, of course, in biopsies.
We can detect cancer cells in different samples, but we can also do this for different types of cancer. Currently, the company is evaluating what will be the next indication and we are considering starting with the cancers that really need diagnosis in the early stages, such as lung or breast cancer.
We haven’t started developing our next indications, but when we subject our file to the European authorities and to the U.S, we will start our next indication.
What are Micromedic’s and BioLight’s plans for the future?
That's a good question. Micromedic has a lot more cancer diagnostic technologies aside from CellDetect that it is looking to scale up, to bring additional products to the market.
Micromedic has some very interesting collaborations with the University of Florida and universities in Israel, so we do believe that we will be able to present a portfolio of cancer diagnostic products.
BioLight, which is the parent company of Micromedic, is also very active in the ophthalmology field.
Our way of thinking is to create division of technologies focused on a specific medical condition combining different technologies that are dealing with the same medical condition from different angles. Micromedic does this for cancer diagnostics and XLVision is dealing with eye conditions such as glaucoma and dry eye. They also recently included a technology for use in AMD. Both divisions are looking to expand their portfolio.
So both divisions are focusing on defined diseases, trying to leverage what we call knowledge synergies by encouraging interactions between project managers, R&D managers, and most importantly, the scientists that are involved.
Where can readers find more information?
Further information is available on the BioLight and Micromedic websites:
If people want to refer specifically to bladder cancer, the company will be presenting at the American Urology Conference, in New Orleans: http://www.aua2015.org/
About Suzana Nahum-Zilberberg
Mrs. Suzana Nahum-Zilberberg is the CEO of BioLight. Previously Mrs. Nahum-Zilberberg worked at Teva Pharmaceuticals Industries Ltd for 12 years in several positions, her last role being Vice President Asia and Pacific, leading the penetration of Teva into Japan and China.
In her position Mrs. Nahum-Zilberberg led the JV agreement with Kowa Pharmaceutical in 2008 and the acquisition of Taisho Pharmaceutical in 2009, leading Teva to become the fifth largest generic company in Japan.
Mrs. Nahum-Zilberberg holds a BA in Accounting and Economics from Tel Aviv University, MBA in Finance and Marketing from Tel Aviv University and is certified CPA.
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