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PlexBio Gets CE Mark for PCR-based Coronavirus Detection Kit

NEW YORK ─ Taipei, Taiwan-based PlexBio said Monday that it has received the CE mark for its IntelliPlex SARS-CoV-2 Detection Kit and the test is now available in European countries.

This PCR-based test detects SARS-CoV-2 in nasopharyngeal swab specimens from patients who may or may not exhibit symptoms of COVID-19, the firm said.

PlexBio added that its test runs on its IntelliPlex platform for multiplex assays and can process up to 564 samples within eight hours. The kit leverages the multiplexing capabilities of the IntelliPlex platform by simultaneously detecting the E, N, and RdRp genes in the virus, which mitigates the probability of getting false negative results, the firm said.

PlexBio said it is working with regional distributors to have the IntelliPlex SARS-CoV-2 Detection kit certified in various Association of Southeast Asian Nations (ASEAN) countries where customers are awaiting the availability of high-throughput testing for COVID-19. The 10 ASEAN nations include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.

The company said it is working closely with its strategic partners to further expand its product portfolio to include a series of respiratory disease panels that complement the SARS-CoV-2 Detection Kit. It anticipates launching the respiratory disease panels soon.