Emergency Use Authorization: Page 5

Molecular Designs creates PCR test for COVID-19 variant
By LabPulse.com staff writers
To detect the variant, labs must sequence the viral genome from positive SARS-CoV-2 tests but the process is expensive and slow, the firm said. The new test targets four signature mutations in the variant, and Assurance Scientific Laboratories is currently validating the test for clinical use. If all goes according to plan, Assurance will fill for authorization under its existing U.S. Food and Drug Administration emergency use authorization.
February 21, 2021
2020 11 11 22 30 8321 3d Closeup Coronavirus 400
Luminex receives $11.3M from BARDA for multiplex assay
By LabPulse.com staff writers
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
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Bio-Rad's sales rise in Q4, full fiscal year
By LabPulse.com staff writers
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
2019 08 20 21 56 5455 Bio Rad Aacc 2019 400
Qiagen plans FDA resubmission of coronavirus rapid antigen test
By LabPulse.com staff writers
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
2021 01 22 00 49 6908 Qiagen Testing 400
HHS outsources review of some lab-developed COVID-19 tests
By LabPulse.com staff writers
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
2019 10 24 21 35 9053 Lab Scientist 400
Everlywell, Gingko Bioworks to distribute COVID-19 antigen test
By LabPulse.com staff writers
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
2021 01 08 23 53 2466 Business Hands Cooperation 400
FDA warns of false results from Curative COVID-19 test
By LabPulse.com staff writers
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
2019 02 13 19 24 5396 Fda Logo V2 400
Beckman Coulter launches high-throughput COVID-19 assay
By LabPulse.com staff writers
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
2019 08 09 22 20 6739 Beckman Coulter Aacc 2019 400
Abbott receives CE Mark for IgG COVID-19 test
By LabPulse.com staff writers
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
2019 05 02 23 38 2538 Check Mark 400
Eurofins debuts 2 products to test for COVID-19
By LabPulse.com staff writers
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
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
Euroimmun launches test to distinguish between COVID, flu
By LabPulse.com staff writers
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
2020 06 15 18 14 5259 Swab Sample Collection 400
Bluejay teams up with Toray on COVID-19 point-of-care test
By LabPulse.com staff writers
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
2019 11 15 22 54 6305 Business Hands 400
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