The UK government said that everyone in England will be able to access free lateral flow testing for SARS-CoV-2 twice a week to support the reopening of society.
The test runs on DiaSorin's Liaison XL Analyzer and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.
The third-party consulting group used for the analysis recommended using a survey to set Medicare payment rates to reduce the reporting burden on laboratories.
The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.
The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year.
The company said the test can be used to evaluate effective antibody levels after SARS-CoV-2 infection or vaccination, as well as to assess adaptive immunity.
The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.
The firm's assay leverages reverse transcriptase quantitative PCR to amplify two separate regions of the HIV-1 genome to monitor HIV-infected patients.
The firm said the new contract will provide funding to support the production of up to 6.7 million COVID-19 antigen and antibody tests per month for the US market.
The company said that it is on track to meet its goal of shaving $7.2 million in costs this year as it undertakes a recently announced restructuring plan.
FIND aims to make easy-to-use self-tests available in low- to middle-income countries and has set aside an initial budget of $15 million for the initiative.
The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.
The program, which will provide supplies of rapid, at-home antigen tests, aims to determine if frequent self-testing can reduce community transmission of the virus.
The FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations.
