FDA Grants Great Basin’s Strep Test 510(k) Clearance
Great Basin Scientific has won 510(k) clearance for its Group B Streptococcus molecular diagnostic test, the Salt Lake City, Utah, devicemaker announced Tuesday. The company expects to launch the GBS assay in the second quarter of this year.
The test uses an integrated cartridge system to target the cfb (CAMP factor) gene in pregnant women, and is equipped for both low-plex and multiplex targets.
Compared to culture-based testing which can take up to 48 hours, the GBS assay provides results in 90 minutes, the company says. Molecular diagnostics can increase GBS detection by 30 percent.
GBS disease is the leading infectious cause of death and illness among U.S. newborns, says the CDC. An estimated 10 percent to 30 percent of pregnant women are subject to GBS genitourinary tract colonization which can be transferred during labor and delivery.
This is the company’s second FDA-approved assay. The devicemaker’s first test, a Clostridium difficile diagnostic, was cleared in 2012. — Jason Scott