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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.
DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.
Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.
The firm's test detects DNA from tick-borne bacteria directly from a patient's blood, and clinical studies are planned for the 2021 tick season.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
The immune sequencing firm has engaged the FDA in discussions over how to get regulatory approval for one test for several seemingly different diseases.
The multiplexed paper-based assay could rapidly diagnose early-stage Lyme disease more accurately and at a lower cost than existing methods.
The development team said a protein biomarker platform they are developing may differentiate Lyme from other conditions in doctors' offices.
The immunoblots detect IgM and IgG antibodies to Borrelia species, including B. hermsii, B. miyamotoi, and B. turicatae.
The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases.