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The Cellex qSARS-COV-2 Antigen Rapid Test includes a disposable rapid antigen testing lateral flow device to detect active SARS-CoV-2 infection.
The agency said review of Chembio's EUA request was not a priority because it would have a limited impact on testing capacity.
Innovita Biological is also developing a rapid, at-home SARS-CoV-2 serology test that it licensed to Scanwell Health earlier this year.
Some insiders emphasize the importance of doing rapid turnaround testing of asymptomatic people, while others contend lab tests ought to be the modality of choice.
Oxford Immunotec said recent trial data suggest that individuals with SARS-CoV-2 specific T cells but without detectible antibodies may be protected from infection.
The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.
The company's CoV2Ag test is a high-throughput chemiluminescent immunoassay in development for the detection of SARS-CoV-2 antigens in nasal swabs or saliva specimens.
The ELISA-based test has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2 specific IgG against two virus antigens.
The advent of high-throughput antigen testing is especially timely as global regions are suffering second and third waves of infections during the coronavirus pandemic, Ortho said.
The company is drawing on its previous experience developing and commercializing its HIV self-test to make progress on a test that could be used for three different indications.
Life science product revenues nearly doubled, offsetting a continuing slide in the firm's diagnostics revenues.
The firm signed a deal with Zotal to be exclusive Israeli distributor of the test, which measures proteins in patient blood to detect diabetic kidney disease.
The company's goal is to help laboratories and smaller diagnostic firms accelerate test development and provide end-to-end test design assistance.
The chemiluminescence enzyme immunoassay is designed to detect SARS-CoV-2 antigens in nasopharyngeal and nasal swab samples.
The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.
The deal comes one week after the Netherlands said it was buying 9.2 million of the tests. The Canadian government is also purchasing 2,172 BD Veritor Plus Systems.
The agreement covers Proprietary Innovation's line of SARS-CoV-2 assays including its lateral flow chromatographic-based antibody and antigen tests.
Qiagen will develop T cell-based lab tests to detect prior exposure to SARS-CoV-2 using discoveries from TScan's target discovery platform.
The government will provide around 670,000 rapid antigen tests to local health officials across England this week to expand testing in asymptomatic individuals.
The IgM test had nearly 100 percent specificity with 1,400 negative samples and 98 percent sensitivity with samples 15 to 30 days after symptom onset.