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Novacyt Obtains CE Mark for Extraction-Free COVID-19 PCR Test

NEW YORK ─ Novacyt on Wednesday announced that it has obtained CE marking for a next-generation high-throughput PCR test for COVID-19, called COVID-HT Direct, and is making the test available in Europe and other regions that accept the designation.

COVID-HT Direct eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost, and labor by up to 30 percent, the firm said.

The test is being used by one of the UK’s Lighthouse laboratories, and is being validated for use with private high-throughput PCR laboratory partners, the firm added. A Lighthouse Laboratory is a high-throughput facility dedicated to COVID-19 testing for the UK's national testing program.

Paris-based Novacyt said the CE marking and launch of COVID-HT Direct comes on the back of its launch of another high-throughput PCR test for COVID-19, called COVID-HT, last June.

Last August, Novacyt also announced that it had received CE marking for its Winterplex PCR-based respiratory panel, which can differentiate SARS-CoV-2 from common winter infections.