"DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" Notification of Approval and Application of Public Medical Insurance for In Vitro Diagnostic Medicine and Launch of "Fully Automated Genetic Analyzer G1" (Real Time RT-PCR)

News release to members of the press "DELBio Dagene G1 New Coronavirus Detection Reagent Kit" Approval of in-vitro diagnostics, application of public medical insurance, and "Fully automatic gene analyzer G1" (Real Time RT-PCR ) Release Notice Delta Electronics Co., Ltd. (Headquarters: Minato-ku, Tokyo; Representative: Ke Jinxing) has announced the "DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" from DELBio, Inc., a medical device manufacturer affiliated with the Delta Group. As of May 27, 2021, the Ministry of Health, Labor and Welfare has approved an in-vitro diagnostic product and received public medical insurance coverage. In response to this, we will start selling "DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" and "Fully Automated Genetic Analyzer G1" from today. "DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" is a reagent that detects the SARS-CoV-2 gene by RT-PCR (Reverse Transcription Polymerase Chain Reaction) method. Ribonucleic acid (RNA) is extracted from biological samples such as nasopharyngeal swabs, cDNA is amplified by real-time reverse transcription PCR, and SARS-CoV-2 RdRp and N genes are detected. The "Fully Automated Genetic Analyzer G1" (general medical device (class I) notified) does not require special skills, and uses a dropper as an accessory to eliminate the need for pipettes, centrifuges, etc. It is a genetic analyzer that fully automates a series of operations from RNA extraction to amplification/detection and result judgment without requiring dedicated equipment. The detection of the new coronavirus is fully automatic and takes about 80 minutes. Accurate testing can be performed quickly and in a small space, so high-precision PCR testing is possible even in small clinics and hospitals. "DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" was developed with the cooperation of the university hospital, using nasopharyngeal swabs (11 positive specimens, 15 negative specimens) and the National Institute of Infectious Diseases. We evaluated the performance of this product in SARS-CoV-2 detection by comparing it with a general PCR test method according to the "Pathogen Detection Manual 2019-nCoV Ver.2.9.1". As a result, both the positive and negative concordance rates were 100%. We believe that this product can contribute to further expansion of the SARS-CoV-2 inspection system and prevention of infection. We will continue to work to provide products that meet the needs of medical institutions and patients, and contribute to a better future for people. [Product overview]・Fully automatic genetic analyzer G1

・DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit [Caution] G1, the product listed in this release, is a medical device. Due to the regulations of the Pharmaceuticals and Medical Devices Act, medical devices are prohibited from being sold or resold without permission or notification. "DELBio Dagene G1 Novel Coronavirus Detection Reagent Kit" is an in-vitro diagnostic drug as defined in Article 2, Item 14 of the Pharmaceutical Affairs Law. * "In-vitro diagnostic drug"　Pharmaceuticals that are intended exclusively for use in diagnosing diseases and that are not used directly on the human or animal body. [About DELBio] In the Delta Group, DELBio provides consistent services from research, product development, and manufacturing in the fields of medical devices, medical imaging systems, and in-vitro diagnostics. Backed by a strict QA system and manufacturing process, we guarantee product quality, stability, and ease of use. The R&D team is dedicated to research platforms for diabetes care, respiratory care, medical imaging systems and various diagnostic systems. We also cooperate with world-renowned research institutes and academic institutions to pursue innovation and product excellence. We want to contribute to a better future for people by designing and manufacturing high quality medical products. [About the Delta Group] The Delta Group is one of the world's leading manufacturers of switching power supplies and cooling fans, and also provides a wide range of equipment and services from power management, electronic components, displays, FA, networks to renewable energy solutions. . Founded in Taiwan in 1971, we now have sales offices and manufacturing bases around the world. Website: http://www.delta-japan.jp/ [Contact for inquiries regarding this release] Delta Electronics Co., Ltd. Marketing Section e-mail: jpmarketing@deltaww.com [Contact for inquiries regarding this product] e-mail: jpmed @deltaww.com [Company profile] Company name: Delta Electronics Co., Ltd. Representative: Ko Shinko Location: 2-1-14 Shibadaimon, Minato-ku, Tokyo Established: June 1991 URL: http://www.delta-japan .jp