New Tests Enter the Scene as COVID-19 Rages On

Tests for the coronavirus (COVID-19) continue to roll in as the U.S. faces a public health crisis. Thermo Fisher Scientific and Mayo Clinic are the latest with diagnostic contributions. Waltham, MA-based Thermo Fisher is the second company to be granted an Emergency Use Authorization for a commercially developed COVID-19 test. MD+DI reported Roche received this designation late last week too for the cobas SARA-COV-2 test. In a press release, Thermo Fisher said the authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The company said the estimated time-to-result also includes time for sample preparation and instrument analysis. "The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc Casper, chairman, president and CEO of Thermo Fisher said in prepared remarks. The news comes on the heels of two significant developments from Thermo Fisher, which include the company making a bid to acquire Qiagen and entering into a companion diagnostic collaboration for non-small cell lung cancer with Janssen. Mayo Clinic’s said its test “Severe Acute Respiratory Syndrome (Coronavirus-2 (SARS CoV-2), Molecular Detection has been fully validated and submitted to FDA for review and E...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news