OME Technology Seeks EUA for Breakthrough 20-Minute PCR Test by End of Year
OME Technology today (7/22) hosted the launch conference and tier-1 customer MOU signing ceremony for its independently developed “Accuracy Sens. No.1 Nucleic Acid Analyzer” at Taipei International Conference Center. The product is now undergoing clinical trials at a national university hospital and its clinical data should become available by mid-August. The company is hoping to achieve emergency use authorization (EUA) in Taiwan by the end of this year.
OME Chairman Liao Kou-fu stated that the COVID-19 pandemic has been a serious problem around the world for several years now. To make its own contribution to fighting the epidemic, OME drew on more than ten years of experience in optics, electrical engineering, mechanical engineering, and bio-medical technology to build the “Accuracy Sens. No.1 Nucleic Acid Analyzer”, a 100% independently developed portable PCR testing machine. The new invention offers testing with high accuracy within the shortest amount of time in the world. Its use will hopefully help the economy, business and ordinary people with their return to normalcy. People in Taiwan will be able to safely, happily, and without fear.
OME President Vincent Wu emphasized that “Accuracy Sens. No.1 Nucleic Acid Analyzer” has already passed SGS testing and Ce certification. It can perform a PCR test in 20 minutes and test 4 sets of reagents at once. If 256 machines are daisy-linked together it can upload 1024 sets of data at once. The product can be used by itself or as multiple units connected together for different scenarios. In other words, data can be transmitted to each control center for immediate sorting. If the result is negative then the mask can be removed, and if the result is positive then the patient directed to seek medical attention or provide with telecare. There is no uncertainty over false positives or false negatives. The product is built to mil-grade standards for water, wind, sun, fire, high/low temperature resistance. It has also passed SGS testing and obtained CE certification. CE certificate is proof of this revolutionary testing product’s safety and reliability. It has passed stress testing under all kinds of environmental conditions including high/low temperatures and different levels of humidity.
Dr. Calvin Cheng from OME’s Biomedical Department added that “Accuracy Sens. No.1 Nucleic Acid Analyzer” is a revolutionary nucleic acid testing products that is compatible with other pathological tests as well. In addition to COVID-19, tests for other diseases such as monkeypox, liver disease, as well as diseases relating to economic animals and pet companions are also under development. Once more test agent’s complete development, a single “Accuracy Sens. No.1 Nucleic Acid Analyzer” unit will be able meet the testing requirements for all kinds of diseases. This will not only realize the vision of home testing, targeted treatment and de-centralization but also help unlock medical treatment capacity. Prof. Zheng believed that the COVID-19-related market will last for at least one year. “Accuracy Sens. No.1 Nucleic Acid Analyzer” is very competitively priced and is small enough to be held in one hand (volume is just 10cm3). Its compact and streamlined design makes it suitable for border checkpoints, different types of transportation (e.g. aircraft, ferries), enclosed venues (e.g. restaurants, concerts, classrooms), military-use or temporary quarantine stations. OME plans to obtain EUA for “Accuracy Sens. No.1 Nucleic Acid Analyzer” in Taiwan this year then immediately apply for the home use permit.
The OME Technology team owns a portfolio of independently developed core technologies. It also has a platform for developing integrated, optical, mechanical and electrical solutions. Key products include linear guide, ball screw, and biomedical devices. International certifications included ISO 9001, ISO 13485, GMP, SGS, and others. The “NAPB-16-0000” liquid handling system in particular won the 2022 Taiwan Excellence Award.
Liao Kou-fu said that OME Technology has followed a clear strategy of focusing on “high-end, niche, and long follow-up” markets. That is why the export sales to Europe, US, Japan and Korea accounted for 60% of company sales. OME Technology is now planning to take advantage of strong customer approval in the Europe to enter the European market at the end of July. A “bottom-up” strategy will be adopted to introduce products back to Taiwan. At the same time, the “high-end, niche, and long follow-up” core strategy will be accelerated through the continued development of new products in order to maximize returns and profits.