Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Nanosphere's Staphylococcus Test

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has given 510(k) clearance for the firm's Verigene Staphylococcus Blood Culture Nucleic Acid Test, or BC-S.

The test was submitted to the agency as the first phase of a multi-step strategy by the Northbrook, Ill.-based company to obtain clearance for a larger test panel, the Verigene BC-GP, which will have up to 16 bacterial/resistance marker targets on a single test cartridge. A submission to FDA for BC-GP is under review, and last week Nanosphere obtained the CE-IVD Mark to market the panel in Europe.

The BC-S test is for detecting Staphylococcus aureus, Staphylococcus epidermis, and the mecA gene, which confers resistance to the antibiotic methycillin/oxacillin. The test provides species and resistance detection from two types of gram-positive blood culture bottles in about 2.5 hours, compared to three days with conventional culture methods, Nanosphere said.

In addition, studies have shown that rapid molecular identification of bacteria as well as resistance can save hospitals up to $21,000 per patient, the company said.

The Scan

Cancer Survival Linked to Mutational Burden in Pan-Cancer Analysis

A pan-cancer paper appearing in JCO Precision Oncology suggests tumor mutation patterns provide clues for predicting cancer survival that are independent of other prognostic factors.

Australian Survey Points to Public Support for Genetic Risk Disclosure in Relatives of At-Risk Individuals

A survey in the European Journal of Human Genetics suggests most adult Australians are in favor of finding out if a relative tests positive for a medically actionable genetic variant.

Study Links Evolution of Stony Coral Skeleton to Bicarbonate Transporter Gene

A PNAS paper focuses on a skeleton-related bicarbonate transporter gene introduced to stony coral ancestors by tandem duplication.

Hormone-Based Gene Therapy to Sterilize Domestic Cat

A new paper in Nature Communication suggests that gene therapy could be a safer alternative to spaying domestic cats.