US Regulators Quickly Approve Roche’s New and Faster COVID-19 Test


    schwit1 quotes the International Business Times: Swiss pharmaceutical giant Roche announced Friday it had received emergency approval from U.S. regulators for a new and much faster test for diagnosing the deadly new coronavirus… The test can be run in high volumes on fully automated equipment, Roche said, suggesting it could provide more results far faster than other tests available. “We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of Roche’s diagnostics unit, said in an interview with Bloomberg News. Widespread testing is essential in the race to rein in the spread of the virus, which has so far infected more than 130,000 people and killed nearly 5,000 worldwide. The new Roche tests, which will also now be available in markets that accept the European CE-mark certification, are run on Roche’s widely available cobas 6800/8800 systems and can provide results within 3.5 hours, the company said. In a 24-hour period, the largest machines can provide results on up to 4,128 tests, it said. Fierce Biotech points out that “emergency use” of the test was quickly approved by U.S. regulators within 24 hours: In addition to the one-day approval, the FDA said it did not object to Roche pre-shipping its COVID-19 tests to laboratories ahead of time, so they could be used immediately following the authorization… The test is designed to detect nucleic acid strands of the SARS-CoV-2 virus from nasal or oral swabs. However, the company said negative results do not preclude an infection and should be combined with clinical observations and the patient’s history and contact with the disease… “Roche is committed to delivering as many tests as possible and is going to the limits of our production capacity,” the company said in a statement, and it expects to have millions of tests available per month. Read more of this story at Slashdot.


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