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Neihu, Taiwan (January 14, 2021)
Abnova announced today that it has added point-of-care (POC) utility to its COVID-19 Viral Antigen Rapid Test for US EUA submission. During the current COVID-19 pandemic resurgence, Abnova has expanded its rapid test utility from clinical laboratory under trained personnel to POC, near patient environment under non-laboratory personnel. Under the FDA guidelines, clinical laboratory and POC utilities are distinct and require separate clinical performance for validation. Most importantly, POC application drastically increases the potential worldwide market of Abnova’s COVID-19 Viral Antigen Rapid Test.
So far, all of the Taiwan approved COVID-19 viral antigen rapid tests are for clinical laboratory utility only. In contrast, all of the FDA EUA approved rapid tests in the US are for both clinical laboratory and POC utilities. They are developed by US domestic companies which already have many years of expertise in rapid test development, preclinical and clinical testing. Abnova has met this first challenge by attaining a 100% sensitivity for it clinical laboratory personnel usage. Strategically, Abnova has setup a separate clinical cohort demonstrating its POC utility so that it can compete equally and effectively in the US market.
Abnova COVID-19 Viral Antigen Rapid Test has also received CE-IVD certification and awaiting Taiwan EUA certification. The emergence of B.1.1.7 mutated virus has genetic mutations in the spike protein region of the viral genome which increases affinity toward the ACE2 epithelial protein, resulting in increased infectivity and transmission. Abnova rapid test detects the nucleocapid N protein which is unrelated to the mutated spike S protein, and hence is capable of detecting the new B.1.1.7 mutated virus. Upon successful EUA approval in the US, Abnova aims to further leverage its rapid test for utility in the home self-testing market which will require an external reader. |
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Abnova has established a comprehensive portfolio of fully integrated solutions to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products, and services relating to circulating rare cells, circulating exosomes, and circulating cell-free RNA for early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance, and monitoring. Abnova facility is for proprietary bioreagent and high-throughput automation development and manufacturing for clinical trials and IVD commercialization. (www.abnova.com)