Superbug Presentation

Definitions Genotypic: the DNA makeup Phenotypic: the expression of the DNA (i.e. say different proteins) Antibiotic Resistance (wait for it)

How Many Cells in a Human? How many cells do you think are in an average human? Take a quess. 32 Trillion cells (how many zeros?) 32,000,000,000,000 human cells

How Many Bacterial Cells In a Human 39.7 trillion bacterial cells in a human So, there are more bacterial cells in us than human cells The good thing is most of the bacteria in and on us are good bacteria, they do most of the work to digest our food as well as protection most of the external bacteria on our skin.

PROBLEM ADDRESSING No simple solution allowing “unskilled” and marginally skilled individuals to measure yes/no test to determine if humans and domestic pet are carriers of antibiotic resistant bacteria Running out of new antibiotics Lack of good antibiotic stewardship

Initial Market and Development Currently there is no simple solution allowing “unskilled” individuals to measure yes/no test to measure the presence or absence of specific resistant bacteria Almost all of the testing is either sent off to an external lab for animals (as well as humans) to be tested. This typically takes 2-3 days to turn around sample.

BioFlash-Dx Technology Unique biosensor; utilizing engineered mammalian B cells Detects Bacteria in the limits of 10 cfu detected with dirty sample Proteins, carbohydrates and nucleic acids Viruses (i.e. H5N1) Toxins Extremely fast; typically < 2 min detection, TAT 10 min or less Can be manufactured and scaled up at minimal cost Shelf life of 6+ months on developed assays Potential multiplexing on BioFlash-Dx systems Speaker: David Yost The foundation of the IBI technology is a engineered mammalian B cell that has been designed to detect a specific marker through a classic antigen antibody reaction. This reaction causes a release of light that is then captured using a luminometer. This reaction is very fast and very specific. And it can be manufactured and scaled up with little investment. The B cells are stored at -80degrees C. and transported to users on dry ice. Its important to note that during our development trials we had no issues with transportation and handling. Are there any questions on this slide? Bioluminescent proteins engineered to B cell Specific target antibodies engineered into B cell The reaction is light based

Structure of MRSA Capsular polysaccharides lyphostaphin action CP5, CP8, CP332 lyphostaphin action protein A Speaker: Ed Gravell Knowing that IBI had the capability to solve the key issues within the clinical laboratory environment, the focus was to develop a rapid, low cost assay that would sit on a platform which could be expanded to other markers. Using the market research and industry intelligence as a foundation, IBI focused its energies on the creation of a MRSA assay that utilizes a direct nasal specimen. The MRSA assay has been tested in both a 4 hour and 5 minute format with exciting results. Are there any questions on this slide? I will now turn it to David to talk about the results of the developmental trials. PbP2a

Typical Time-line for Development and Launch CSM done upfront work Why not start with classic IVD test and regulatory path? Vet Dx goes through FDA but at MUCH lower bar then human testing

WE will be using bacteriophage WE will be using bacteriophage. They are a special “virus” that ONLY infects bacteria NOT humans

Typical Device We Will Be Making

QUESTIONS?