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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.
Last week, readers were most interested in FDA's post about the effect of SARS-CoV-2 variants on certain tests.
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.
Quidel also announced it has been named the official diagnostics partner of the San Diego Padres Major League Baseball team.
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.
News items for the in vitro diagnostics industry for the week of March 29, 2021.
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 test runs on the firm's Curian rapid fluorescent immunoassay and detects four species of a common foodborne pathogen.
Of the 31 companies in the index, 11 firms saw their stock prices increase, while 20 saw their share prices decline.
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.
Iqvia and Quest established Q2 solutions, originally known as Quintiles Research, as a joint venture in 2015 with Quest owning 40 percent of the firm.
The test leverages ELISA technology and uses non-pathogenic viral proteins, enabling its use in common lab settings either manually or automatically.
The firm is using Mesa Biotech's Accula system for the testing, beginning Thursday, the start of the 2021 MLB season.
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.
The latest US Food and Drug Administration Emergency Use Authorizations allow the tests to be used for serial testing in asymptomatic individuals.
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 company also said it is planning on filing for Emergency Use Authorization for its SARS-CoV-2 test in the second quarter of 2021.
The panel, which includes three immunoassays, identifies the infection stage of the Epstein-Barr virus from a blood sample.
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.