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Group A streptococcus

HiberGene hopes to launch its assays, based on loop-mediated isothermal amplification, in the EU in the third quarter of this year.

The waiver opens up a significant new opportunity for Alere within the physician office market, according to a company executive.

NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.

NEW YORK (GenomeWeb News) — By analyzing the genomes of more than 3,600 strains belonging to a pathogenic group of Streptococcus bacteria, a team of researchers has unraveled the genetic events leading to its emergence as the cause of an epidemic.

Researchers last week provided a glimpse of the clinical performance of a trio of extraction-free molecular assays currently being developed by clinical diagnostics firm Quidel.

NEW YORK (GenomeWeb News) – Meridian Bioscience said on Monday that its illumigene Group A Streptococcus and illumigene Group B Streptococcus assays have been recategorized by the US Food and Drug Administration as "moderate complexity" tests under the Clinical Laboratory Improv

Health management services and diagnostics firm Alere recently updated investors on the progress of a pair of nucleic acid testing platforms that are currently under development at the company and represent the firm's entrée into molecular diagnostics.

Meridian Bioscience said today that its Illumigene molecular diagnostic products accounted for 16 percent of its fiscal first quarter revenues, which increased 13 percent over the same quarter last year.

Roche this week announced the commercial availability of a molecular test for cytomegalovirus viral load.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Meridian Bioscience's Group A Streptococcus molecular diagnostic test that runs on its illumigene platform, the company said after the close of the market on Monday.

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In PLOS this week: preconception carrier screening program results, comparative genomics-based analysis of Elizabethkingia meningoseptica, and more.

Canadian regulators are beginning to share information from new drug studies, Undark reports.

In a column at the Dallas Morning News, the Stanley Medical Research Institute's E. Fuller Torrey says the Human Genome Project hasn't delivered on promised results.

Researchers explore a possible genetic cause for some cases of sudden infant death syndrome, KOMO News reports.