Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that its tests detect the deadly toxins produced by the recent outbreak strain E. coli O104:H4. E. coli O104:H4 is the novel shiga toxin-producing strain associated with a number of deaths in Europe. It has also caused hemolytic uremic syndrome (HUS) (a type of kidney failure) in hundreds of others. In the United States, one confirmed and three suspected cases of E. coli O104:H4 infections have been identified in persons who recently traveled to Germany. One case of HUS in Massachusetts has been confirmed as matching the German outbreak strain. Among the three suspected cases, two are cases of HUS, one case each in Michigan and Wisconsin. The third suspected case, a person with shiga toxin-positive diarrheal illness, is still under investigation. (See information posted to the CDC website.) Meridian has been able to conduct testing on clinical isolates from one of these clinical samples utilizing its two distinct tests for shiga toxin-producing E. coli (STEC) and confirmed that its tests have correctly identified the samples as shiga toxin-producing and, more specifically, that it produces shiga toxin-2.
Shiga toxin-producing E. coli, or STEC, are common foodborne contaminants. It is the shiga toxins that the organisms produce, either shiga toxin 1 or shiga toxin 2, that cause serious complications in the infected person. The most commonly detected STEC strain in North America is O157:H7. Mike Loeffelholz, PhD, ABMM, Associate Professor in the Department of Pathology and Director of the Clinical Microbiology Laboratory at University of Texas Medical Branch in Galveston, TX states,, “Detection of E. coli O157:H7 alone will under-detect shiga toxin-producing strains of E. coli (STEC). A U.S. study showed that roughly half of STEC isolates from routine stool samples were non-O157 strains (Hedican et al. 2009. CID). It is estimated that approximately one third of all illnesses caused by STEC, including hemolytic uremic syndrome (HUS), is due to non-O157 strains (Mead et al. 1999. EID; Mellmann et al. 2008. EID). As the distribution of gene targets for shiga toxins 1 and 2 varies among O157 and non-O157 STEC (Hedican et al. 2009. CID; Kappeli et al. 2011. EID), it is important that diagnostic assays detect both toxins. Some studies indicate that shiga toxin 2 has a higher association with HUS (Friedrich et al. 2002. JID), so the ability of assays to differentiate between the two toxins may also be clinically relevant.”
Meridian’s Premier ™ EHEC (cleared by the FDA in April of 1995) and Immuno Card STAT! ® EHEC (cleared by the FDA in February of 2007) assays detect both toxin types. Immuno Card STAT! ® EHEC provides an additional advantage in that the test differentiates between shiga toxin 1 and shiga toxin 2. Rapid identification of the toxin 2 type will enable physicians to immediately isolate and appropriately treat infected patients to reduce the likelihood for the development of HUS.
As expected, the toxin produced by the deadly E. coli strain from Europe is detected by Meridian’s shiga toxin-detecting assays, Premier ™ EHEC and Immuno Card STAT! ® EHEC. Richard Eberly, Chief Commercial Officer, stated, “Meridian will continue to support global demands by ensuring these kits are available in all regions where they are needed to detect and control infection.”FORWARD LOOKING STATEMENTS