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Clostridium difficile

NEW YORK (GenomeWeb News) – Microbioal genetic analysis firm OpGen today announced it has received Clinical Laboratory Improvement Amendments certification.

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.

NEW YORK (GenomeWeb News) – Becton Dickinson's BD Diagnostics segment today said that its BD Max Cdiff Assay has been cleared by the US Food and Drug Administration for marketing in the US.

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.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared 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.

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The Centers for Disease Control and Prevention estimates more people get sick and die from drug-resistant germs than previously thought, the Washington Post reports.

According to the Associated Press, three universities and a healthcare institution are sharing a gift of $1 billion.

New rules seek to limit the type of scientific and medical research that can be used to guide public health regulations, the New York Times reports.

In Nature this week: FreeHi-C approach simulates Hi-C data from interacting genome fragments, and more.