Molecular diagnostics company GenturaDx has completed external HSV 1&2 alpha studies for its IDbox™ instrument and cassette-based tests. Conducted at an external CLIA laboratory, the study analyzed more than 130 samples, including more than 70 clinical specimens. The study met performance objectives, paving the way for GenturaDx to start beta studies in the third quarter.
“We wanted to get early end-user input on our system, so we chose to run this study at an external CLIA laboratory,” said Jesus Ching, PhD, the company’s chief scientific officer. “We are delighted with the feedback from the external laboratory, and anticipate completing beta studies this year, and clinical studies in 2012.”
The IDbox System incorporates all aspects of proprietary, real-time PCR testing from sample preparation through result generation in a single-use cassette, enabling a true “sample-in/result-out” experience.
GenturaDx’s fully integrated and automated design brings rapid, highly specific, and sensitive nucleic acid detection capabilities to laboratories of any size; such as those either wishing to add automation to their molecular menu or those that have previously been unable to afford or access molecular testing. The compact, self-contained IDbox System allows for sample processing of one to 12 samples per instrument in two to four hours. The company anticipates offering a rapidly expanding menu of FDA cleared assays with an initial focus on sexually transmitted diseases and respiratory illnesses.
Developing a system with a small footprint and unmatched ease of use, GenturaDx aims to bring molecular testing to the estimated 5,000 small-to-medium sized hospitals that rely on traditional culture techniques or immunoassay testing.
“Our research shows that hospitals are seeking an affordable, easy-to-use molecular diagnostics platform with an expandable menu of assays,” said GenturaDx CEO Mark Bagnall. “Our rapid, highly automated platform aims to remove barriers to adoption for these hospitals, and deliver the best possible testing solution at the lowest possible price.”
Bagnall said GenturaDx is actively seeking partners interested in adapting additional assay content to its platform or those that offer distribution channels in specific geographies. “We are always looking for partners who can provide greater value to the technology we’re bringing to the marketplace, as we seek to expand the menu for our leading-edge molecular diagnostic device,” he said.
