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.
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 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.
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.
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.
