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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.
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 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.
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 FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations.
Illumina said it plans to "vigorously defend" the deal and oppose the FTC, which previously helped scuttle Illumina's proposed acquisition of Pacific Biosciences.
The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.
Osang previously granted nonexclusive US distribution rights to the PCR-based test to SG Blocks and has a manufacturing arrangement for the test with Nexus Dx.
Concentric by Ginkgo has been partnering with labs across the US in more than 15 states to run testing for schools offering in-person education.