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Neihu, Taiwan (July 13, 2021)
Abnova is outpacing the competition by speeding up the GMP manufacturing of the COVID-19 neutralizing antibody tests for the post COVID-19 era. As many countries have expanded their COVID-19 vaccination programs, the COVID-19 viral antigen tests for pandemic prevention will shift to neutralizing antibody tests. Specifically, the development of neutralizing IgG antibody, not just an general antibody response, after an immunization will be the key determining factor for ongoing protection. Abnova not only has successfully developed the RBD ACE2 ELISA and pseudovirus formats but also a rapid test format for the neutralizing assay for starting clinical studies at the beginning of August.
In light of increased competition in viral antigen rapid test for both POC and Home Use domestic market, Abnova aims to commercialize the neutralizing antibody test as a key driver for revenue generation in the coming months upon EUA approval. For the neutralizing antibody test, ELISA and pseudovirus platforms will dominate the POC market. For the Home Use market, the rapid test will be preferred platform. So far, US FDA has granted only one EUA for the ELISA test, and none for the pseudovirus and rapid test. The difficulty for rapid test is even higher because current rapid tests in the development could not detect the low threshold of protective neutralizing antibody.
In the post COVID era, neutralizing antibody monitoring will become increasingly important for adequacy of vaccine protection over time. Also, as the COVID-19 variants particularly the delta (Indian) variant becomes the dominating strain of COVID-19 transmission, the neutralizing antibody protection will likely to wane more quickly over time. Recently, Pfizer/BioNTech has applied to the FDA for EUA approval of third booster vaccine injection to further increase the neutralizing antibody after two injections for further protection against the delta variant. |
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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)