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 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 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 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.
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.
