The ratio of IL-6 to IL-10 biomarkers might give clinicians insight into how severe the inflammatory response to SARS-CoV-2 could be in certain patients.
Kantaro said that authorized clinical testing laboratories in Europe can use its enzyme-linked immunoassays, which detect IgG antibodies to two coronavirus antigens.
The reissued EUA expands the types of samples that may be used with the Broad Institute's PCR-based SARS-CoV-2 test, which was first authorized in July.
Ortho said its antigen test offers 98.9 percent concordance to real-time PCR tests, making it a viable alternative for mass-scale testing during the pandemic.
Among its recommendations, the FDA said antigen tests for the coronavirus should have a minimum sensitivity of 80 percent for all sample types submitted.
FIND said the funds were awarded as part of the Access to COVID-19 (ACT) Accelerator Diagnostics Pillar to accelerate testing to help mitigate the pandemic.
The third quarter continued Abbott's streak of offsetting base business declines with COVID-19 testing, with 38 percent growth in the diagnostics business.
The company said it could produce 3 million antigen tests before the end of this year and between 15 million and 20 million tests per month starting next year.
MDx revenues grew 67 percent while centralized and POC solutions revenues were down 13 percent, tissue Dx slid 1 percent and diabetes care declined 10 percent.
The company said its rapid antigen test provides results in 15 minutes and is easy to administer for healthcare professionals using a nasopharyngeal swab.
Genomic Vision said it will distribute a test that detects coronavirus antigens from swabs and another that detects IgG and IgM antibodies to the coronavirus in blood.
The company's recent license agreement with Abbott is part of its plan to move its Simoa technology into the clinic via partners in LDT and IVD development.
