As president and CEO of BioView (TASE:BIOV), Dr. Alan Schwebel has led the company, a world leader in automated fluorescence in situ hybridization (FISH) cell imaging and analysis, since 2009. Dr. Schwebel, who has more than 30 years of experience in senior management positions in leading medical device and medical diagnostic companies, joined BioView in 2002 as VP of sales and marketing. In this interview with BioTuesdays.com, he discusses the company’s cutting-edge technology, exclusive worldwide distribution and development agreements with Abbott Molecular and a new lung cancer diagnostic test.
Can you give us a brief overview of BioView.
The company was established in Israel in 2000, made its initial sales in 2003 and went public in March 2006. We also have a fully owned subsidiary in the U.S., which is responsible for sales and support in America. Our system platforms have been cleared by the FDA, as well as in Europe, China and Korea. We leverage our knowledge and extensive expertise in the areas of medical devices combined with clinical and research applications to create breakthrough imaging and analysis solutions for use in cytology, cytogenetic, pathology clinical and research laboratories.
What are BioView’s strategic pathways?
In the area of FISH imaging clinical applications, we continue to pursue additional opportunities with new diagnostic assays and tests with innovators in critical tumor types, where changing paradigms of treatment are needed, such as in cervical, prostate and lung cancers. We also are extending our reach with academic and clinical collaborators in the area of circulating tumor cell (CTC) applications, also known as “liquid biopsies.” Finally, we are pursuing internal R&D, utilizing our biology and imaging experts to develop diagnostic tests to provide access to the consumable products markets.
How do you tackle circulating tumor cells?
BioView’s CTC application was designed to automate the imaging and detection of rare circulating tumor cells, while its unique analysis algorithms provide a set of mathematically based cellular and signal features. These features are vital for assay development and characterization. They improve the sensitivity of detection, reduce analysis time and enable progress validation of research projects. As the identification and quantification of CTC in peripheral blood sample is an extremely lengthy process, and as CTC research becomes more clinically-oriented, so grows the need for an automated, high-throughput system with specialized algorithms for the detection of the cells of interest. BioView’s CTC application incorporates field-proven algorithms, developed in collaboration with leading cancer research centers worldwide, making it the ideal solution for both clinical and research laboratories looking to enhance their productivity and assay development process.
BioView is pursuing various strategic pathways, including FISH imaging clinical applications, circulating tumor cell (CTC) applications, and the development of diagnostic tests to provide access to the consumable products markets
What are your competitive advantages?
We have integrated the very best hardware components and developed the most advanced algorithms and platforms, packaged in a user friendly interface, in order to create the most advanced automated process. This allows us to tailor the work flow for imaging cells, reviewing the analysis and preparing reports for different laboratories, with different requirements. Another key advantage we have is our worldwide distribution agreement with industry leader Abbott Molecular, which develops and markets in vitro FISH assays that run on our instrumentation.
Are there risks relying on one major distributor?
The alternative is not very promising for a company the size of BioView. There are many countries around the world that if we were not working with a large partner like Abbott, we would not be in a position to sell our equipment. In the U.S., we market in conjunction with Abbott, through our subsidiary, which allows us to retain contact with customers in the field.
Can you tell us about your global customer base?
We have more than 350 systems installed in the U.S. and the rest of the world. These installations include hospitals such as Cleveland Clinic, City of Hope Cancer Center and New York University, and private/commercial labs such as SRL Laboratories in Tokyo and HistoGeneX in Belgium, and research labs such as MD Anderson Cancer Center and Dana Farber Cancer Institute.
BioView’s Encore imaging system accommodates multiple FDA cleared and CE marked FISH applications, as well as whole-slide virtualization, for remote review and analysis
What is the extent of BioView’s applications portfolio?
Some of our approved applications include breast cancer PathVysion, lung cancer ALK, onco-hematology, bladder cancer UroVysion and Amnio FISH applications. (Pathvysion and UroVysion are trademarks of Abbott Molecular.) We also have full coverage for all commercially available solid tumor FISH probes, matching between consecutive tissue sections for targeted FISH analysis, virtual slide imaging for local and remote view of histology stained sections, tissue micro array and cytogenetics applications.
How important is early detection of lung cancer?
The average life expectancy of a lung cancer patient is around 18 months but if detected early, life expectancy can be more than five years. However, only 16% of lung cancers are detected at an early curable stage. The need is to better identify patients for a full standard-of-care diagnostic work up.
Can you give us an overview of your development program?
One element of our new oncology assays program is with Abbott, which is developing new in vitro diagnostic tests for companion diagnostics. We have an agreement with Abbott to develop the software algorithms to analyze images for their tests. In parallel, we have our own program to develop an in vitro diagnostic test based on FISH biomarkers, which we have licensed from MD Anderson Cancer Center. We are developing a non-invasive test based on a patient’s sputum, with an analysis using our DUET imaging system.
What’s the status of your lung cancer test?
In September, we received CE Marking, which enables the test to be marketed and sold in Europe and countries that have adopted the European regulatory standards under the CE Mark. We also are collaborating with Kindstar Global to market the test in China. In addition, we recently signed an agreement with Diagnostic Solutions (Australia) for the marketing of the lung cancer test in Australia and New Zealand. During the first phase of the agreement, Diagnostic Solutions will perform a validation trial at a leading hospital in Sydney and will apply to local authorities for Therapeutic Goods Administration regulatory approval and reimbursement code. As a second phase, Diagnostic Solutions will purchase and distribute BioView’s imaging system combined with the lung cancer diagnostic test kits.
What are your goals for 2016?
Number one is to increase our sales footprint with Abbott, especially in Asia-Pacific countries, thanks to recent regulatory approval in China of our DUET Automated FISH Scanning and Analysis systems. Number two is continued development of our circulating tumor cells segment as a lead-in to personalized medicine. And finally, we intend to advance our lung cancer diagnostic test.
BioView’s global customer base includes more than 350 systems installed in the U.S. and the rest of the world