Great Basin Lands FDA Clearance for Shiga Toxin Test

The FDA has granted Great Basin Scientific 510(k) clearance for its Shiga toxin direct test for the detection of Shiga toxin-producing E. coli.

This is the only FDA-cleared test capable of pinpointing STEC and the serotype O157 strain directly from a patient specimen, the company says.

The company aims to create a cost-effective and timely option versus traditional testing methods that take anywhere between 36 to120 hours to receive a result. — Anisa Jibrell