1. Shiga Toxin E. coli Rapid detection is key!

2. Intestinal Diseases Difficult to diagnose clinically – Most have very similar symptoms Treatment & patient management varies depending on diagnosis Prompt accurate diagnosis is essential for patient health and treatment decisions Patients have often waited to seek medical care 212000845 v2

3. Shiga Toxin-Producing E. coli (STEC) Also called enterohemorrhagic E. coli (EHEC) Produce toxins that cause disease, Stx1 &/or Stx2 Prevalence rate up to 4.1% of samples – Similar to Salmonella, Campylobacter, and Shigella Diarrhea (bloody) cramping, fever nausea Hemolytic Uremic Syndrome (HUS) 3 12000845 v2

4. STEC Transmission Community acquired Food & water borne Outbreaks 4 12000845 v2

5. Hemolytic Uremic Syndrome (HUS) Potentially fatal renal failure More prevalent in pediatrics Antibiotics may increase risk of HUS due to toxin release from dying STEC cells Standard STEC treatment – Avoid antibiotics due to risk of HUS – Rehydration and monitoring 5 12000845 v2 Toxin E. coli

6. Who should be tested? CDC & Joint Commission: All acute community acquired diarrheas Antibiotic use is common for GI disease, may be deadly in a STEC patient Rapid identification of potential outbreaks Screening Criteria Test ifRisk Visible bloodPresentNot all STEC positives have visible blood SeasonSummer-FallCan occur year-round, esp. with imported produce Patient AgePediatrics, Elderly Not all cases are peds & elderly 6 12000845 v2

7. O157 and non-O157 strains O157:H7 is the most common US strain – Many labs only test for O157 (e.g. mac-sorb plate) Over 100 non-O157 strains cause disease – April 2013 outbreak of O121 – 2011 German outbreak of O104 Over 4,000 cases, 908 developed HUS Plate culture will NOT detect non-O157 strains – Must test for Stx toxins (rapid assay or ELISA) 7 12000845 v2

8. SHIGA TOXIN QUIK CHEK Simultaneous detection and differentiation of Stx1 & Stx2 Multiple sample types suit any situation – Fresh & Frozen Stool – Stool in transport media (Cary Blair, C&S) – Broth culture – Plate culture only The only rapid test FDA-cleared for direct stool testing for Shiga Toxin E. coli 8 12000845 v2

9. Why Direct Stool Testing? Direct StoolBroth Culture n =887770 Sensitivity98.0%95.7% - 100% Specificity99.8 – 100%99.5 – 99.9% From package insert. Results vs. verocell cytotoxicity 9 12000845 v2 Get results in time for proper patient care – Identify STEC patients, confidently treat non-STEC – Diagnose patients 16-24 hrs. sooner than with broth culture Get results on every sample – Not all samples grow in broth, doesn’t mean patient is negative

10. Time is Critical CDC guidelines: prompt diagnosis is critical for managing STEC patients – Early diagnosis reduces the chance of inappropriate antibiotic use and risk of severe complications like HUS Early identification of outbreaks is critical for public health 24 hours for broth culture is too long to wait when direct stool testing provides results in 30 min. 10 12000845 v2

11. 11 12000845 v2 © 2014 Alere. All rights reserved. The Alere Logo and Alere are trademarks of the Alere group of companies.

12. 12 12000845 v2