1. Superbug Presentation

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

4. 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

5. 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.

7. 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

9. 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.

10. 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

11. 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

12. 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

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

14. Typical Device We Will Be Making

15. QUESTIONS?