Close Menu

herpes

The firm is pursuing CE-IVD clearance of the new platform populated with a menu of its MGB assays.

The assays use specimens from symptomatic patients for the qualitative detection and differentiation of HSV-1 and HSV-2 with results generated within one hour. 

The presentations were part of a Quidel-sponsored workshop and poster sessions at the Clinical Virology Symposium in Daytona Beach, Fla.

The revenue increase was driven by growth in Meridian's Diagnostics segment and particularly sales of its Illumigene product line.

The test uses the company's TOCE primer technology for multiplexed real-time PCR and is the first product Seegene has taken through the FDA.

The firm also announced that it had placed more than 250 new QIAsymphony molecular diagnostics systems in 2014, surpassing its goal.

NEW YORK (GenomeWeb) — In cases where US Food and Drug Administration-cleared assays do not exist, clinicians often use their own lab-developed PCR assays to test for conditions of interest. This process can involve separate extraction and amplification steps, and extensive hands-on time.

CHICAGO (GenomeWeb) — Seegene this week plans to submit its first molecular diagnostic test for US Food and Drug Administration clearance, an assay for herpes simplex virus I and II that uses the company's TOCE primer technology for multiplexed real-time PCR.

NEW YORK (GenomeWeb) – IMDx said today it has received clearance from the US Food and Drug Administration to market the IMDx HSV-1/2 on the Abbott m2000 instrument.

NEW YORK (GenomeWeb) — Quidel said today after the close of the market that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.

Pages

The FDA and CDC call for a pause in administering Johnson & Johnson's SARS-CoV-2 vaccine while reports of rare blood clots are looked into, reports the Wall Street Journal.

According to the Associated Press, a Swiss program aims to shepherd long-term science projects and diplomacy.

CNN reports that two new studies suggest the B.1.1.7 SARS-CoV-2 variant may be more transmissible, but may not lead to more severe disease.

In PNAS this week: analysis of pathway affecting acute kidney injury, parental-specific allelic expression in horse placenta, and more.