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Emergency Use Authorization: Page 5
Luminex receives $11.3M from BARDA for multiplex assay
The panel will be able to run on all Aries 6- and 12-cassette systems. Results will be available in less than two hours, the firm said. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
February 18, 2021
Bio-Rad's sales rise in Q4, full fiscal year
For the fourth quarter, Bio-Rad posted net sales of $789 million, an increase of 26.5% compared with sales of $624 million in the same period the year before. The company's net income for the most recent period was $839 million, compared with income of $554 million in the fourth quarter of fiscal 2019.
February 11, 2021
Qiagen plans FDA resubmission of coronavirus rapid antigen test
Developed with Elume of Australia, the QIAreach test is designed to process 30 swabs per hour, according to the companies. Qiagen had filed for an emergency use authorization (EUA) of the product with the FDA, but voluntarily withdrew its application in November because there were some chemistry issues that needed to be addressed. The company says that with feedback from the agency it has resolved these and is ready to submit for an EUA.
January 20, 2021
HHS outsources review of some lab-developed COVID-19 tests
NDA Partners will conduct technical and regulatory reviews of applications for emergency use authorization (EUA) submitted for LDTs, the company said. The company will review EUAs submitted for the COVID-19 lab-developed tests, including tests that combine detection of the novel coronavirus and other respiratory pathogens, according to the contract awarded by the HHS Office of the Assistant Secretary for Health (OASH).
January 20, 2021
Everlywell, Gingko Bioworks to distribute COVID-19 antigen test
Access Bio's antigen test is designed to be administered by healthcare professionals and includes a disposable, rapid antigen testing lateral flow device to detect active COVID-19 infection in as little as 15 minutes. The test has received emergency use authorization from the U.S. Food and Drug Administration.
January 7, 2021
FDA warns of false results from Curative COVID-19 test
The company's Curative SARS-Cov-2 Assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test used to detect the SARS-CoV-2 virus. The test was developed by KorvaLabs, which Curative acquired in May, and received emergency use authorization from the FDA in April.
January 3, 2021
Beckman Coulter launches high-throughput COVID-19 assay
The assay has 93% positive percent agreement (PPA) within seven days after symptom onset and 100% negative percent agreement (NPA). The assay also has a detection threshold of 33 TCID50/mL, which is two to 200 times lower and thus more sensitive than the reported limits of detection for most point-of-care (POC) antigen tests, the firm said.
December 17, 2020
Abbott receives CE Mark for IgG COVID-19 test
The new test determines both the presence and titer of antibodies in the blood to detect the spike protein of the virus surface in serum and plasma.
December 14, 2020
Eurofins debuts 2 products to test for COVID-19
The GSD NovaGen SARS-CoV-2 antigen rapid test delivers results within 15 minutes, according to Eurofins. It works with nasopharyngeal swabs and achieved diagnostic sensitivity of 93% and diagnostic specificity of 93%, the company reported.
December 13, 2020
Euroimmun launches test to distinguish between COVID, flu
The real-time polymerase chain reaction (PCR) diagnostic received the CE Mark, allowing it to be sold in countries that accept the European sign of approval. The test can detect SARS-CoV-2, influenza virus type A, and influenza virus type B, helping physicians better identify the cause of infection in patients with acute symptoms.
December 13, 2020
Bluejay teams up with Toray on COVID-19 point-of-care test
Toray's Symphony interleukin 6 (IL-6) technology is a portable test for quantitation of IL-6 in whole blood for COVID-19 patients who present progressing symptoms and have a high risk of needing intubation with mechanical ventilation, according to Bluejay.
December 7, 2020
IVD firms ready high-throughput antigen tests
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
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