Skip to main content
Premium Trial:

Request an Annual Quote

Quidel Gets FDA Clearance for Multiplex Strep Assay

NEW YORK (GenomeWeb) — Quidel said today that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct Strep multiplex real-time PCR assay.

The new test detects and differentiates between pyogenic Group A and pyogenic C or G streptococcal throat infections.

Group A Streptococcus are Gram-positive bacteria that reside primarily in the nose, throat, and skin and are responsible for several illnesses such as strep throat, skin infections, or toxic shock syndrome. Meantime, Group C and G Streptococcus are less understood than Group A, although some strains have been increasingly reported to cause infections similar to those caused by GAS. Most are treated with penicillin or other beta-lactams. These non-Group A strains are also found in a significant number of Group A-negative symptomatic patients, and treatment appears to shorten the symptomatic period of disease.

The new assay is part of Quidel's Lyra brand of ready-to-use PCR reagent kits specifically designed to be compatible with a laboratory's existing thermal cycler.

The Scan

Genetic Ancestry of South America's Indigenous Mapuche Traced

Researchers in Current Biology analyzed genome-wide data from more than five dozen Mapuche individuals to better understand their genetic history.

Study Finds Variants Linked to Diverticular Disease, Presents Polygenic Score

A new study in Cell Genomics reports on more than 150 genetic variants associated with risk of diverticular disease.

Mild, Severe Psoriasis Marked by Different Molecular Features, Spatial Transcriptomic Analysis Finds

A spatial transcriptomics paper in Science Immunology finds differences in cell and signaling pathway activity between mild and severe psoriasis.

ChatGPT Does As Well As Humans Answering Genetics Questions, Study Finds

Researchers in the European Journal of Human Genetics had ChatGPT answer genetics-related questions, finding it was about 68 percent accurate, but sometimes gave different answers to the same question.