|Great Basin Scientific Inc. (NASDAQ:GBSN) gets nod from FDA for Group B Strep Molecular Diagnostic Test, Shares Soar|
|By David Fowler|
|Wednesday, 22 April 2015 17:33|
Molecular diagnostics company, Great Basin Scientific Inc. (NASDAQ:GBSN), has got clearance from U.S. Food and Drug Administration for the molecular diagnostic test for Group B Streptococcus (GBS).This is the company’s second one to be given approval by the FDA. The first test, Clostridium difficile, or C. diff, was approved in May 2012.
The company is hoping to launch GBS assay commercially in quarter two of this year.
Co-founder and Chief Executive Officer Ryan Ashton, opined that getting FDA clearance for the GBS test is a big milestone for the company both for expansion of menu as well as proof of its ability to meet product deliverables.
He added that the firm is committed on delivering hospitals and reference labs some products which would give accurate and definitive results and hence the firm is keen on growing the menu of tests over the next one and half years for meeting needs for easy-to-use as well as cost-effective molecular diagnostic testing.
According to the Canters for Disease Control, GBS disease is an infectious cause of morbidity as well as mortality among newborns in the United States.
Infants having GBS possibly get pneumonia and sepsis along with early-onset infections leading to meningitis. The long term consequences can be deafness as well as developmental disabilities. Most importantly, the death rate of early-onset GBS disease is four to six percent.
There are an estimated 10 to 30 percent of pregnant women with GBS in the genitourinary tract that may be transferred to the infant during delivery.
These mothers asymptomatic and hence the CDC recommends pregnant women getting screen done at 35 to 37 weeks of gestation. This assay gives results within 90 minutes. The test results give physician with vital information for making timely and appropriate decisions for preventing the spread of the disease to the infant during delivery.
The firm’s aim is to give assays which can be given at less cost than other molecular diagnostic solutions.
Shares of the company soared 45% to $5.13 on hefty volume.