Lyme disease
Abbott, QuidelOrtho, Werfen, Others Gain 510(k) Clearances in August
The US Food and Drug Administration granted marketing clearances for immunoassays for a variety of infectious diseases including syphilis, Lyme, and COVID-19.
Top Five Articles on 360Dx Last Week: NIH Funds Syphilis Dx; Sentencing in COVID Fraud Case; More
Last week, readers were most interested in a story about 10 new awards from NIH aimed at simplifying the testing process for congenital and adult syphilis.
The UCLA-led research team used synthetic peptides and a machine learning-developed algorithm to create a test for the detection of Lyme disease antibodies in serum samples.
ID-FISH Gets FDA Clearance for Lyme Disease Immunoassay Kit
The company said that the test kit includes 31 Lyme antigen bands for improved sensitivity.
The Paris-based startup plans to use €1.5 million in pre-seed funding to support R&D on a test kit and deliver preclinical data by early 2025.
May 5, 2022
Apr 20, 2021