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The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.
The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
Warrior Diagnostics' RT-PCR test detects SARS-CoV-2 RNA in nasopharyngeal swab samples and uses the same primers and probes as the CDC SARS-CoV-2 test.
Menarini said the test, which detects IgG and IgM antibodies, is available in the US based on receipt of an FDA EUA by its manufacturer, Healgen Scientific.
The experts said that antibody testing cannot indicate an individual's immunity or help with return-to-work schemes but have use for public health agencies.
The firm said the contract will help it complete development of the ELISA test and submit for Emergency Use Authorization with the FDA.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
In January a federal court unsealed a False Claims Act suit from an industry insider that alleges a Myriad subsidiary engaged in a fraudulent kickback scheme.
The Swiss company said the higher revenues were driven by an 11 percent year-over-year increase in revenues from its Alba reagent business.
Avalon said it intends to establish a facility in the US for the manufacture and assembly of antibody and PCR-based detection systems.
The tests are designed to detect and differentiate immunoglobulin M and immunoglobulin G antibodies against SARS-CoV-2 in various blood samples.
A group of companies has teamed up to evaluate both the usability and ultimate behavioral consequences of at-home testing for COVID-19 antibodies.
The Swedish company said it will use the funds in part to accelerate the commercialization of its PanCan-d test for early-stage pancreatic cancer detection.
The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.
he firm will use the proceeds to expand manufacturing capacity for its existing and in-development COVID-19 assays.
Some parts of Europe turned to serology testing early to try to get a handle on the pandemic but had to quickly pull back after those tests performed abysmally.
Sienna said that Unilabs, a commercial lab in Sweden, is evaluating its hTERT bladder cancer test for routine use.
The FDA has added an at-home self-collection template to its SARS-CoV-2 EUA guidance as more firms seek to develop sampling kits for use in homes.
Sema4 said it will provide SARS-CoV-2 viral and antibody testing to Connecticut residents including state employees and first responders.
The company said it has production capacity for more than 50 million tests per month and that its high-throughput analyzers can deliver up to 440 tests per hour.