Dental News - Interview: A non-invasive, quick and easy method to collect epithelial cells

Dental Tribune International

Sun. 30. April 2017

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Early detection of oral cancer or other serious oral health conditions is significant for successful treatment. To improve the process of collecting tissue from the mouth, a researcher at Ege University’s Faculty of Dentistry in Izmir in Turkey has developed the oral biopsy brush, which allows sampling of the entire oral epithelium. Dental Tribune Online spoke with Dr Pelin Güneri, Professor at the Department of Oral and Maxillofacial Radiology, about the functionality of the brush, its benefits and plans for a market introduction.

Prof. Güneri, how did the idea for the oral biopsy brush evolve?
The idea is the result of having been in the field for over 25 years. The increased number of oral mucosal lesions in the population over this time and the difficulty in utilising accurate non-invasive adjunct materials and devices to preliminarily establish the nature of oral mucosal lesions led to the development of the oral biopsy brush.

The current instrument we use in the clinic for oral mucosal lesions is not specific to oral use, being the same brush developed for vaginal brush biopsy. During the sampling, the rolling motion of the brush may destroy the epithelial cells and thus decrease the diagnostic information obtained with a brush biopsy. Additionally, brush biopsy samples may not contain an adequate number of cells or may not be collected from all epithelial layers of the oral mucosa.

After diagnosing squamous cell carcinoma at the left lateral border in a 23-year-old patient, I decided to try to find a solution. The brush biopsy procedure is already known and used elsewhere in the world, especially in India, where a high number of oral cancer cases are observed. It is a non-invasive, quick and easy method to collect cells from the epithelium; however, because of the above-mentioned shortcomings, it is longer commonly used.

How does the brush work?
Our oral biopsy brush is designed to be used in the oral mucosa to take samples from all over the oral epithelium. It has a disposable head of metal bristles formed by D-shaped wires. Used with a sweeping motion, it exerts a scaling effect via the bristles and collects cell samples from all three layers of oral mucosa, transferring them to the upper part of the brush. With this unique design, the brush bristles fully contact with the oral epithelium and collect less damaged cells. It also has a light within the handle, allowing the user to clearly see where the sampling is being done in the oral cavity.

Who can use the brush?
Specifically designed for medical and dental staff who are involved in protecting the health of oral tissue and treating disorders of the related structures, the oral biopsy brush may be utilised by general dentists, specialists, general medical practitioners, otorhinolaryngologists, dermatologists and even by trained health care professionals, such as oral hygienists.

Which group of patients can benefit from this invention and why?
The device can benefit patients with suspicious oral mucosal tissue lesions and who have systemic conditions or who are on medication that contra-indicates surgical biopsy, or those with large multifocal mucosal lesions that require multiple biopsies or recurrent lesions that have undergone earlier therapy, or those who have had previous head and neck cancer. Since local anaesthetic administration is not required to use brush biopsy, it may be recommended for patients who have dental anxiety and dislike injections. Also, the absence of incision eliminates the need for bleeding control and suturing.

What research has been conducted so far?
We have completed our preliminary investigations on ten patients. Histological analysis of the cell samples was done by an experienced oral pathologist, using well-defined and approved criteria. The initial results showed that the novel brush yielded samples containing more intact cells from deeper layers of the epithelium compared with the conventional oral biopsy brush.

Do you hold a patent on the oral biopsy brush?
We have a pending patent application, which is about to be granted. After I explained what I had in mind to overcome the pitfalls of the current biopsy brush to a group of young colleagues, they encouraged me to apply for a patent. With the guidance of Ege University’s Technology Transfer Office, I applied for a patent in 2015. At the same time, this project was presented to the Scientific and Technological Research Council of Turkey to apply for funding in order to establish a company for production of a prototype. In April 2016, we founded REMORIS.

What is your business plan for REMORIS?
As a very young start-up engaged in the development of medical and dental products and services, REMORIS aims to transform early-stage medical technologies into successful and top-level quality products according to the most current and advanced applications in national and international research fields. However, currently, our priority is to develop tools and devices that will provide more accurate and quicker diagnosis of malignant oral lesions.

Biopsy brush design was the first product that we started to work on; the second product is a punch biopsy instrument to be used to collect tissue samples in full-cylinder form. We next intend designing a stapler to attach the tissue point easily with a single instrument. These three products will be sold as a kit.

Currently, we are holding meetings with companies interested in our invention, but no agreements have been finalised yet. If other companies are also interested, we would be glad to meet them as well.

What is your intention with regard to the market introduction of the oral biopsy brush?
A prototype is being used in the university clinic, since the brush is not available on the market yet. As REMORIS, we are well aware that, in order to be able to reach to our target population, the brush needs to be affordable and widely available in medical and dental markets. Only here in Turkey, over three million people are diagnosed with oral mucosal lesions annually, according the Turkish Ministry of Health. These need to be further investigated with a non-invasive, chairside adjunct device before a conventional biopsy procedure so that unnecessary biopsy-related expenses can be avoided. To that end, our brush will be available for purchase from online dental stores and the company’s website. We are planning to present our product to universities and hospitals on a large scale so that dental and medical practitioners can obtain it easily. The unit price of the brush will be in the range of US$5–10, depending on the version of the brush; however, the final price will be announced at the end of the year.