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The changes include who can order tests for beneficiaries, who can bill CMS for certain testing-related services, and the inclusion of antibody tests as a covered service.
Seroconversion for IgG and IgM occurred simultaneously or sequentially, and IgG and IgM titers plateaued within six days of seroconversion.
The effort is receiving $1.5 billion in funding with up to $500 million set aside for a competition among researchers developing rapid testing technologies.
Leinco said as part of the agreement it will use its protein expression technology platform to rapidly scale up manufacturing of the antibodies.
With few FDA Emergency Use Authorized serology tests and little independent validation, US labs must choose among 100 assays of unknown quality.
The test will run on DiaSorin's Liaison XL immunoassay platform. Five thousand platforms are installed worldwide, including 600 in US labs.
Aytu has committed to purchasing at least 1.25 million tests within the first three months of the deal, including 500,000 tests immediately.
The aim will be to establish the performance of serology tests for COVID-19 that are being marketed without FDA review and those seeking Emergency Use Authorization.
The assay, called COVID-19 ELISA IgG Antibody Test, detects human IgG antibodies in serum and plasma from individuals suspected of prior infection with SARS-CoV-2.
Healthy adults from across the US with no confirmed history of COVID-19 and no current symptoms are eligible to participate and will be enrolled over the phone.