InTray™ Colorex™ VRE (Vancomycin Resistant Enterococci) For the clinical identification of acquired, VanA and VanB type Vancomycin resistance in E. faecalis and E. faecium High Throughput - Once the device is inoculated no other culture preparation is required saving time Cost Savings - Reduces laboratory materials and medical waste High specificity - Selective for the growth vancomycin resistant enterococci PRODUCT BIO BioMed Diagnostics' InTray™ Colorex™ VRE serves as a microbiology sample collection, transport, and culture device for simultaneous growth, observation, and chromogenic differentiation of vancomycin resistant enterococci. BioMed’s patented InTray™ system saves time and money while reducing exposure to collected samples by combining several procedures into a single device. This device makes preliminary identification easy by producing distinctive color differences between the growth of VRE strains of enterococci in as little as 18-24 hours. Further, the InTray™ Colorex™ VRE inhibits the growth of mold, fungi, and non-vancomycin resistant bacteria increasing specificity. The specially formulated chromogenic media makes detection and preliminary visual identification easy, while inhibiting potential interference in obtaining accurate results. BENEFITS Convenient - Combines collection, culture, and observation into one device Easy to use - Minimal lab procedures and equipment needed Easy to store - 6 month shelf life under refrigeration (2-8 °C) Easy observation - No fogging or condensation on the InTray™ viewing window Safe - Fully enclosed InTray™ system prevents contamination and reduces exposure to collected samples PRODUCT SPECIFICS Storage - Refrigeration (2-8 °C) Shelf Life - 6 months Incubation - 18 - 24 hours at 37 °C BIOMED InTray™ MaMactimd under one or mom US p Sample ID_ The InTray™ system consists of a re-closable outer seal containing an optically clear, anti-fog window. The seal creates an airtight 2” diameter chamber providing a large enough area to streak for isolation. The innovative design of the InTray™ high-performance viewing window makes it possible to place the device directly under a microscope. This removes the need to prepare slides and prevents unnecessary exposure of the sample after inoculation reducing the risk of contamination. By combining both growth and observation into one fully enclosed device, BioMed’s InTray™ system negates the need for multiple procedures increasing throughput and decreasing the cost of laboratory materials and medical waste. Visual Results: • VRE.faecalisf VRE.faecium - Pink to mauve • E.gallinarum/E.casseliflavus - Blue or inhibited • Other bacteria - Inhibited QUALITY CONTROL The InTray™ Colorex™ VRE is tested with ATCC strains of the indicated species. At the time of manufacture, quality control tests are preformed on each lot of InTray™ Colorex™ VRE to ensure viability and sterility. These tests are repeated throughout the product shelf life by BioMed Diagnostics confirming the products ability to support growth of selected species while maintaining specificity. BACKGROUND There are two types of vancomycin resistance in enterococci. The first type is intrinsic, non-transmissible resistance, commonly referred to as VanC, VanD, VanE or VanF resistance. This type is commonly found in E. gallinarum, E. casseliflavus or E. flavescens and demonstrates a low-level resistance to vancomycin. The second type of vancomycin resistance in enterococci is acquired or transmissible resistance, e.g., VanA and VanB, mostly seen in E. faecium and E. faecalis. Quantity Sold 5 Pack (10-6207) 20 Pack (10-6201) Additionally, the InTray™ design lends itself to high performance in the laboratory controlled point-of-care settings as well as off-site locations or austere environments. The InTray™ Colorex™ VRE is a fully enclosed system and does not require any reagents or complicated procedures to inoculate or obtain results. The InTray™ system is also equipped with a small air filter creating a controlled air exchange. To avoid the spread of this resistance to more virulent pathogens, it is crucial to promptly detect the presence of any VanA or VanB resistance and accurately differentiate them from other enterococci. There are significant epidemiologic issues related to acquired vancomycin resistance in enterococci. Vancomycin-resistant Enterococcus infections are

InTray™ Colorex™ VRE(Vancomycin Resistant Enterococci) CORPORATE OVERVIEW BioMed Diagnostics, Inc., a boutique biotech firm and an industry leader since 1989, develops and manufactures in vitro diagnostic devices. BioMed's point-of-care ready tests provide accurate diagnostic tools for scientists worldwide to aid in the identification of bacteria, parasites and fungi. The company formed as the result of a mercy mission conducted by a group of physicians to Central America; there they discovered the need for robust diagnostic tools for use in austere environments. Their experience unleashed the inspiration...