New Shiga Toxin E. coli Rapid Test Receives FDA Clearance

Alere Inc received confirmation that the US Food and Drug Administration (FDA) has cleared the Techlab^® Shiga Toxin Quik Chek test for the US market.

Shiga Toxin Quik Chek is the only rapid diagnostic available that can detect Shiga toxin-producing E. coli (STEC), which can have fatal effects, directly from a stool specimen. The test offers significant advantages over other rapid cassette assays in that it removes the need for overnight bacterial culture preparation. The Shiga Toxin Quik Chek provides results up to 24 hours before other rapid tests, enabling clinicians to initiate patient care sooner and minimise the potential for broader bacterial outbreaks. The test’s considerably shorter sample preparation process also helps to dramatically streamline laboratory workflows.

“The recent FDA clearance of our new Shiga Toxin E. coli test enhances Alere’s position as a market leader for enteric disease diagnostics and is a testament to our strong partnership with Techlab^®, Inc.,” said Jim Post, President of Alere North America. “By narrowing the diagnostic window from a day to 30 minutes, the Shiga Toxin Quik Chek promises to be a significant help to clinicians, facilitating more rapid patient care that leads to better outcomes, improving workflows, and reducing the potential for broader outbreaks.”

In the United States, food- and water-borne illnesses affect up to 70 million people each year and result in more than 200,000 hospitalisations. Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrhoeal illness, and diagnostics for these bacteria account for approximately $16 million of the total enteric disease market. Shiga Toxin 1 and Shiga Toxin 2, produced singly or in combination by more than 200 different strains of STEC, are the enterohemorrhagic toxins that cause disease. O157 is the most well known strain and has been responsible for numerous outbreaks in the past. Several other strains, though, have led to severe outbreaks, and Shiga Toxin Quik Chek detects toxins from both O157 and non-O157 strains.