14th July 2015 Content supplied by: Great Basin Corp.
Great Basin Announces Commercial Launch of Group B Strep Molecular Test
Great Basin Scientific, Inc. have announced its Group B Streptococcus (GBS) test—which received U.S. Food and Drug Administration (FDA) clearance in April is now available to hospitals and laboratories in the U.S.
Two laboratories have already converted their Group B Strep testing to Great Basin’s molecular test, and as of July 7, more than 40 sites are in active evaluation or scheduled to evaluate the sample-to-result test for GBS.
Further, the Company announced its customers evaluating the test are forecasting usage of the GBS test at volumes 50 percent greater than their usage of the Company’s C. diff test.
Vista Labs, a stand-alone 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. Our previous Lim broth culture method for GBS was time consuming and had low-sensitivity. Above all, patient care is a priority for our lab. Getting a definitive diagnostic result our clients can trust, plus hands-on time savings for our employees, combined with the cost savings inherent in their business model makes Great Basin the right choice for our needs,” said Vista Labs Molecular Supervisor Robin Johnson.
“Initial response to our GBS test has exceeded our expectations,” said Great Basin co-founder and Chief Executive Officer, Ryan Ashton. “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 Centers for Disease Control (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. Great Basin brings innovative technology to molecular diagnostic testing with the relative sensitivity of its assay over traditional culture method being 97.9 percent versus 42.3 percent. Additionally, the Company’s GBS assay has a simple workflow that saves critical time for lab clinicians and Great Basin’s no-cost instrumentation and low per-test costs streamlines entry into molecular testing.
The Company also announced today the GBS test has been released as a CE-IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices, making the test commercially available to more than 32 countries in Europe through the Company’s European distributor network. This is the second CE marked molecular diagnostic assay designation for Great Basin following its test for C. diff.
How does it work? - find out more about Great Basin’s isothermal amplification method—helicase-dependent amplification (HDA)
Date Published: 14th July 2015
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