Molecular staph blood culture panel lands 510(k)
Great Basin Scientific has received FDA clearance for its Staph ID/R Blood Culture Panel. The panel is a sample-to-result, automated, DNA multiplex assay for simultaneous identification of Staphylococcus aureus and Staphylococcus species directly from positive blood cultures in about two hours. The panel identifies coagulase-negative staphylococci such as S. epidermis that are the part of normal flora of human skin. The multiplex test also identifies the mecA gene that confers resistance to methicillin and other beta-lactams.
The company said it expects to offer the panel at a significantly lower cost than other molecular blood panels on the market today, making fast, easy diagnosis of staph-caused blood sepsis affordable for the small to medium hospitals that Great Basin serves.