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Singapore Clears New SARS-CoV-2 Assay for Clinical Use

NEW YORK – A new test for SARS-CoV-2 has received provisional authorization for clinical use from Singapore's Health Sciences Authority, according to the Agency for Science, Technology, and Research (A*STAR).

A*STAR and Tan Tock Seng Hospital of Singapore developed the test, which is the first diagnostic to be deployed in the country's hospitals since the outbreak began in December.

The test, called A*STAR Fortitude 2.0, is a real-time PCR assay. Results are generated using a nasopharyngeal swab collected from patients. The product supports the analysis of up to 188 samples per kit.

MiRxes, a Singapore-based diagnostics company that has developed a quantitative PCR-based test for gastric cancer, said that it has been manufacturing the new A*STAR Fortitude 2.0 Kit.

The company reported that it has manufactured 100,000 tests in the past few weeks and has shipped around 20,000 tests to local and regional hospitals. An A*STAR spokesperson confirmed in an email that MiRxes has a nonexclusive license to manufacture the kit, and that A*STAR and its partners are looking to license the test to other manufacturers in Singapore.

There have been 110 cases confirmed in Singapore since Jan. 23, according to the Singapore Ministry of Health. Thirty-two remain hospitalized. No one so far has died of the disease.

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