FDA approved Nanosphere’s Gram-positive blood culture nucleic acid test (BC-GP) on the firm’s automated sample-to-result Verigene® system. The assay received CE-IVD Mark certification in Europe at the end of 2011. The two hour BC-GP bloodstream infections assay provides species-level detection of a range of clinically significant Gram-positive bacteria, as well as key markers of drug resistance, including the mecA, vanA, and vanB genes that confer resistance to methicillin/oxacillin and vancomycin. Nanosphere says it is separately developing a test for Gram-negative blood culture assay for the Verigene system that will also provide species and resistance detection.
The firm is developing a suite of infectious disease assays for the Verigene platform. The multiplexed Verigene RV+ respiratory virus test was approved by FDA in 2011, and tests for C. difficile and a panel of enteric bacterial and viral pathogens are planned for submission to FDA during 2012. Nanosphere’s F5/F2 MTHFR and Warfarin Metabolism test have also been cleared by FDA, and additional cardiac and human genetic tests, including a CYP2C19 assay, and a cardiac troponin I test, are in development.
Nanosphere’s flagship Verigene detection system hinges on its gold nanoparticle probe technology, which uses functionalized nanoparticles that can be coated with either oligonucleotides complementary to the target nucleic acid sequences, or antibodies specific to a target protein. The overall platform comprises the Verigene Processor SP and the Verigene Reader. The processor unit is a modular benchtop analyzer that combines automated nucleic acid extraction, purification, amplification (if required), and hybridization from samples loaded into individual Verigene Test Cartridges. The Verigene Reader manages sample information, reads results from processed cartridges, allows for results printing, internal data storage, and LIS connectivity without the need for an external PC. One Verigene Reader can also control multiple processors, allowing increased throughput.