"NARLabs Medical Device Alliance" Assist Developing Oral Cancer Early Detection Tool Promote Taiwan Medical Device to Global Market
"NARLabs Medical Device Alliance" service platform, established by Instrument Research Institute (TIRI) of National Applied Research Laboratories (NARLabs), assisted the collaborative team of Dr. Jan-song Yu’s Lab at Molecular Medicine Research Center of Chang Gung University (CGU) and S&T BioMed Company to develop "Oral cancer early detection technology and device". The products provide clinicians new strategies and opportunities for early oral cancer diagnosis, treatment effectiveness and medical expenses reduction, and benefit to citizen health. The collaborative team won "Taipei Biotech Awards'' and "16th National Innovation Award" in 2019, and plans to start clinical trials in hospitals in India, Thailand, Malaysia and other countries in the future. This successful development promotes Taiwan's high-quality medical product to world stage and expand the global market.
According to the statistics of Ministry of Health and Welfare in 2018, among the top ten causes of death in Taiwan, malignant tumors (cancers) ranked first, and 206.9 deaths per 100,000 people were due to cancer. Among them, oral cancer ranked fifth among cancer deaths. There are nearly 3,000 deaths from oral cancer in Taiwan each year. With the advances of medical technology, the death rate of the population has decreased year by year, but the number of deaths caused by oral cancer has risen against the trend. Particularly, about 3.6 million smokers in Taiwan are high-risk groups of oral cancer.
Oral cancer detection technology is developed by "Cancer Biomarker Consortium", led by Nobel Prize winner, Dr. Leland H. Hartwell and consisted of Molecular Medicine Research Center of Chang Gung University, Chang Geng Memorial Hospital, Linko and Chi Mei Medical Center. This collaborative team establishes noninvasive biomarker profile to estimate the risk of oral cancer from salivary samples. Relevant research results was published in top international journal "Proceedings of the National Academy of Science" in September 2016, and was selected as featured report.
Later, many doctors from Chang Gung Hospital and Chi Mei Hospital helped to collect saliva samples from oral cancer patients at the clinic. The " Immunoassays for a New Salivary Biomarker of Oral Cancer, OCBM-1" technology was developed with the joint efforts of multiple parties. After technology transfer to S&T BioMed, the team of Molecular Medicine Research Center of CGU and S&T BioMed continued to develop "OCBM-1" immunosorbent assay test reagent, and successfully produced two products, "Oral Cancer Rapid Test ELISA Kit" and "Colloidal Gold Rapid Test Strip". They can be used to rapidly determine the amount of OCBM-1 in saliva samples for early detection of oral cancer potentially.
At present, S&T BioMed has started trial production for these two products. TIRI of NARLabs assisted S&T BioMed with clinical trials in hospitals across Taiwan, product certification application and marketing. Until now, there is no saliva rapid screening test tool / product for early detection of oral cancer approved by any health organization at Taiwan and abroad. After official launch of these two products, the simple, accurate and cost-effective oral cancer test can help aid in the early diagnosis of oral cancer and improve outcomes, and bring the benefit to the health and well-being of the people.
TIRI of NARLabs established "NARLabs Medical Device Alliance" service platform in 2014, clustering the technology resources together from medical electronics, polymer medical device and metal medical device to provide a "one-stop medical device accelerator" services, covering technology, testing, regulations, verification, clinical and financial affairs. The platform assists the teams to develop products to integrate with the international market, greatly reduce medical products research and development costs and risks, and improve the success rate of product launch. Focusing on "to meet customer’s customer need", the service platform has been favored by the industry and academia in a short period of time. The platform has assisted more than 130 R&D teams and platforms, and served more than 200 requests. A total of 20 cases of services for domestic and foreign medical devices to obtain license for production. All these efforts effectively enhance the global competitiveness of Taiwan medical device industry and increase new energy to Taiwan's economic development.