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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.
The assay is the first SARS-CoV-2 neutralizing antibody test to receive Emergency Use Authorization from the FDA.
Following FDA's revocation of the firm's antibody-based test for the coronavirus in June, Chembio is seeking new EUAs for an antibody and antigen test for SARS-CoV-2.
The patented technology has a mechanical readout and can deliver results in less than five minutes, the development team said.
The firm submitted a new Emergency Use Authorization application to the FDA for a serology IgM/IgG test for SARS-CoV-2 after the agency revoked an earlier EUA for a similar test.
If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.
For the full year, the Franklin Lakes, New Jersey company saw a decline in revenues of 1 percent compared to 2019.
The firm's molecular solutions revenues increased 79 percent to $31.7 million due to COVID-19 testing demand.
Residents and workers in the city will be tested with PCR, new lateral flow, and LAMP tests as the country faces a wave of new coronaviruses cases and a lockdown.
The FDA recommended following test instructions and noted that processing multiple specimens in batches could create challenges for proper intubation time.
The test uses the sTRA biomarker to differentiate between different subtypes of pancreatic cancer, including those that are resistant to chemotherapy.
The Logan, Utah-based company's ELISA-based test is designed to detect immunoglobulin G against SARS-CoV-2 in human serum and plasma.
The order is the first from a European government following CE-IVD mark in September. The firm expects to ship 1.2 million of the assays by mid-November.
Quotient recorded a $7.5 million milestone payment in the quarter from Ortho Clinical Diagnostics as part of the companies' restructured distributor arrangement.
Of the 32 companies in the index, 14 firms saw their stock prices increase, while 18 firms' share prices decreased.
Quidel expects to launch at least four new products over the next year and commented on its overall COVID-19 strategy, as well as R&D plans, M&A possibilities, and other updates.
The company is developing a 10-minute, lab-based antigen test as well as a quantitative antibody test that will make use of its sample prep tech.
The firm reported $57.8 million in revenues for its Lyra SARS-CoV-2 molecular diagnostic assays in the quarter.
Thermo Fisher's transplant diagnostics products include antibody detection assays, post-transplant monitoring solutions, HLA typing products, and lab instrumentation.
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.