Skip to main content
Premium Trial:

Request an Annual Quote

GenMark Receives CE Mark for ePlex BCID Gram-Positive and Gram-Negative Panels

NEW YORK (GenomeWeb) – GenMark Diagnostics said after the market closed on Thursday that it has achieved CE marking for its ePlex BCID gram-positive and gram-negative panels.

The firm noted that with CE marking for the BCID-GP and BCID-GN panels, it has achieved the designation for its ePlex family of sepsis panels, which also includes the BCID Fungal Pathogen Panel that achieved the CE mark in April.

"This rounds out our family of ePlex bloodstream infection assays, which we've designed to offer the broadest pathogen inclusivity and drug resistance markers of any multiplex molecular solution on the market today," Hany Massarany, president and CEO of GenMark, said in a statement. He said that GenMark believes the three BCID panels "will have a significant impact on the management of a critical disease state, while bringing clinical, economic, and quality benefits to ePlex customers and their patients."

Earlier this month, GenMark received 510(k) clearance from the US Food and Drug Administration for its ePlex instrument and Respiratory Pathogen Panel, which detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections.

It also increased the size of a previously announced public offering to 6,382,978 shares of its common stock priced at $11.75 per share. The gross proceeds to GenMark, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be about $75.0 million.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.