Clostridium difficile

A new automated molecular diagnostic assay to detect toxigenic Clostridium difficile directly from stool samples was found to have comparable sensitivity and specificity to both the gold standard of culture-based testing and reference testing with a competing assay, Ceph

PrimeraDx, a Mansfield, Mass.-based molecular diagnostics firm, is on track to submit its highly multiplexed PCR-based testing system and associated assay for Clostridium difficile to the US Food and Drug Administration this quarter, CEO Matt McManus said recently.

Life Technologies and Quidel said this week that they have received 510(k) clearances from the US Food and Drug Administration to market the Quidel Molecular Direct C.

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.

Meridian Bioscience has developed a simple, equipment-free, rapid nucleic acid purification method for use with a variety of clinical specimens, and demonstrated that it enables similar analytical and clinical sensitivity as current commonly used methods such as silica-based puri

Quidel this week received 510(k) clearance from the US Food and Drug Administration for its AmpliVue C. Difficile assay.