Emergency Use Authorization: Page 6

IVD firms ready high-throughput antigen tests
By Bruce Carlson
Currently marketed tests are primarily rapid tests performed at the point of care and can be confirmed by polymerase chain reaction (PCR) testing. Several firms now have emergency use authorization (EUA) for rapid antigen tests for COVID-19, and soon a new type of test should be brought to bear: antigen tests on automated systems that can run hundreds of tests per hour. Some of these tests are already marketable in countries that accept the CE Mark.
November 22, 2020
2020 06 04 19 23 9275 Lab Virus Bacteria Research 400
Siemens' SARS-CoV-2 test measures neutralizing antibodies
By LabPulse.com staff writers
The SARS-CoV-2 IgG antibody test is an enhanced version of the assay that became available globally during the summer and can detect neutralizing antibodies and report quantitative results measuring the amounts of neutralizing antibodies present in a patient's blood sample. Fully automated antibody tests like this can be used to help determine whether broad vaccination programs are working, according to the company.
November 17, 2020
2020 05 05 20 17 1261 Sars Co V 2 Antibodies 400
Qiagen releases portable SARS-CoV-2 antigen test
By LabPulse.com staff writers
The test processes samples in two to 15 minutes. Qiagen is marketing and distributing it in the U.S. and has applied to the U.S. Food and Drug Administration for emergency use authorization. It has also applied for the CE-IVD Mark for the European Union.
November 11, 2020
2020 01 21 22 13 2411 Virus Coronavirus 400
Cue secures $481M from DOD for COVID-19 tests
By LabPulse.com staff writers
The funding is awarded by the DOD on behalf of the U.S. Department of Health and Human Services (HHS). Cue will manufacture the tests at its facilities in San Diego.
October 14, 2020
2020 06 15 18 14 5259 Swab Sample Collection 400
Biocept reaches COVID-19 testing milestone
By LabPulse.com staff writers
What's more, the results for the vast majority of these COVID-19 tests have been reported back to healthcare providers within 48 hours, according to the firm.
October 5, 2020
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
FDA publishes performance data for COVID-19 tests
By LabPulse.com staff writers
The lower the limit of detection, the smaller amount of viral material in a sample, which is an indication of a more sensitive test. However, the data do not show a specific test's sensitivity, so it cannot be used alone to determine whether a test should be authorized. Instead, it gives labs and healthcare providers a resource to compare the relative performance of available tests, according to the FDA.
September 15, 2020
2020 05 15 21 10 5109 Fda Sign Dc 400
Qiagen launches 10-minute SARS-CoV-2 test
By LabPulse.com staff writers
The Access anti-SARS-CoV-2 total test detects antibodies in people exposed to the novel virus. It will be available in the U.S. in the coming weeks after it receives an emergency use authorization from the U.S. Food and Drug Administration.
August 25, 2020
2020 01 21 22 13 2411 Virus Coronavirus 400
HHS: FDA review not needed for coronavirus LDTs
By Brian Casey
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Eurofins debuts pooled COVID-19 PCR test
By LabPulse.com staff writers
The test pools five specimens and then tests a single PCR assay while retaining the original, individual samples. Typically, results are provided within 24 to 48 hours.
August 5, 2020
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
FDA spurs development of COVID-19 tests for use outside labs
By LabPulse.com staff writers
The template was designed to support filings of emergency use authorizations for nonlaboratory tests during the COVID-19 pandemic. Such tests could be deployed in workplaces or schools. The aim is to spur development of tests that may be used at home, much like a pregnancy kit. Sensitivity of home tests is lower than those done in labs, but much broader access outweighs this downside, the agency said in a statement.
July 29, 2020
2020 07 30 18 44 2049 Construction Workers Mask 400
PathogenDx wins NIH grant to expand COVID-19 testing
By LabPulse.com staff writers
The grant was provided under the NIH's Rapid Acceleration of Diagnostics (RADx) program for DetectX-Rv, a multiplex viral diagnostic assay that detects COVID-19, as well as COVID-like viruses and subsequent mutations from SARS-CoV-2, according to the firm. The multiplex system will enable thousands of samples to be tested each day, PathogenDx said.
July 28, 2020
2019 08 05 19 10 8249 Dollar Sign 400
Labcorp reports revenue dip in Q2
By LabPulse.com staff writers
For the period (end-June 30), Labcorp had $2.8 billion in revenue, down from $2.9 billion in the same period last year, a decline that was partially offset by COVID-19 testing sales, Labcorp said. Labcorp had second-quarter earnings of $231.6 million, up from $190.4 million in the same period a year ago.
July 27, 2020
2020 05 06 23 12 8891 Lab Corp Headquarters 400
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