Great Basin Scientific Inc, Salt Lake City, has announced commercial availability of its group B Streptococcus (GBS) test, which received FDA clearance in April.

According to the company, more than 40 sites are actively evaluating or are scheduled to evaluate the sample-to-result test for GBS, while two laboratories have converted their GBS testing to Great Basin’s molecular test. According to the company, customers evaluating the test are forecasting usage at volumes 50% greater than their usage of the company’s test for Clostridium difficile.

Vista Labs, a standalone reference lab and long-time customer of Great Basin, chose to adopt the GBS test shortly after evaluation. “The ease of use with no prep steps to run this assay—compared to our prior non-molecular method—provided a huge incentive for us to adopt this test,” says Robin Johnson, molecular supervisor at Vista Labs. “Our previous Lim broth culture method for GBS was time-consuming and had low sensitivity.”

“Initial response to our GBS test has exceeded our expectations,” says Ryan Ashton, cofounder and chief executive of Great Basin. “We believe this speaks to an unmet need in the market that Great Basin addresses by delivering simplified workflow at appropriate cost, and the sensitivity, specificity, and speed of molecular testing that our lab customers demand. Our unique business model, we believe, enables us to launch products efficiently, and we will continue to work diligently to deliver against our product roadmap of tests that assist clinicians in better diagnosing and managing their patients’ infectious disease early and effectively.”

The US Centers for Disease Control and Prevention (CDC) continues to report that a high proportion of early onset GBS disease cases are occurring among infants born to women with negative prenatal GBS culture screens. The relative sensitivity of Great Basin’s assay is 97.9%, while the traditional culture method is 42.3%.

Additionally, the GBS test has been granted a CE mark under the European Directive on In Vitro Diagnostic Medical Devices, making the test commercially available to more than 32 countries in Europe through Great Basin’s European distributor network. This is the second CE-marked molecular diagnostic assay designation for Great Basin, following its test for C. diff.

For more information, visit Great Basin Scientific.