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Innovating Revolutionary Molecular Diagnostics. Our technology dramatically reduces the cost of developing and administering molecular diagnostic assays.

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Presentation on theme: "Innovating Revolutionary Molecular Diagnostics. Our technology dramatically reduces the cost of developing and administering molecular diagnostic assays."— Presentation transcript:

1 Innovating Revolutionary Molecular Diagnostics

2 Our technology dramatically reduces the cost of developing and administering molecular diagnostic assays to such an extent that it can be affordably utilized at the point of care anywhere in the world.

3

4 Over thirty years ago the polymerase chain reaction (PCR) revolutionized the study of genetics, forensics, and biological anthropology.

5 The next major improvement in PCR – the one that will finally make cutting-edge DNA diagnostics affordable and therefore broadly available worldwide – is the CoDx™ platform from Co-Diagnostics.

6 PCR uses engineered segments of DNA or RNA called primers & probes to find, amplify and detect potential pathogens or genetic markers. The next few slides demonstrate how PCR technology works.

7 Sugar-Phosphate (Deoxyribose) Backbone 4 unique nucleic acids or BASES

8 Sugar / Phosphate Backbone (deoxyribose) Bases Pairs (ATCG) (nucleic acids)

9 A-T G-C T-A C-G A ’s only pair with T ’s G ’s only pair with C ’s

10 Polymerase Polymerase is the enzyme in all of our cells that copies or repairs DNA by assembling nucleotides into a copy of the original DNA.

11 Primers are engineered sequences of chemical bases that are complementary to the DNA sequence you want to find. ENGINEERED PRIMER TARGET DNA SEQUENCE Complementary

12 PRIMER DNA Segment of pathogen (i.e. Tuberculosis) A PRIMER finds the target in a sample (sputum, blood, tissue) and attaches itself to the target. A PCR reaction (copying of the DNA target) begins at the primer. 1

13 PROBES are engineered segments of DNA / RNA that have a chemical dye or flourophore attached. The PROBE releases the dye or light when a POSITIVE PCR REACTION has occurred. PRIMER DNA Segment of pathogen (i.e. Tuberculosis) Flourophore 2 ProbeQ Quencher

14 PRIMER Probe Polymerase is the enzyme that copies or extends DNA/RNA When it reaches the probe, it pushes the flourophore off of the DNA causing a glow of LIGHT, which is detected by a PCR device as a POSITIVE reaction. 3 Q Polymerase

15 p F F Q F F Q F F Q F F Q F F Q F F Q Binding event F F Q F F Q F F Q PRIMER DIMERS occur when primers interact with each other rather than the target DNA GOOD PCR REACTIONS are based on COLLISIONS of DNA with both a primer and a probe

16 A p Template DNA Wanted Gene 1 st Cycle 2 Copies 2 nd Cycle 4 Copies 3 rd Cycle 8 Copies 4 th Cycle 32 Copies 35 th Cycle billions of copies Results are plotted in a graph

17 A PCR device measures light from the billions of positive reactions as the flourophores are released. Light = positive No light = negative

18 PRIMERS are designed to be LONG for greater REACTIVITY but they tend to react with each other, causing false positives. SHORTER PRIMER would be ideal but they are far less reactive so they don’t find their target easily, causing false negatives. Consequently, they are not very practical. Primers and Probes are usually two separate molecules Primers react with each other Primers don’t find target F F Q

19 p SHORT PRIMER for greater specificity LONGER PROBE to create reactivity that acts as an “anchor” Connected with a PEG (non-reactive) linker Combine primer and probe into a single, highly sensitive and specific molecule Single Molecule Polyethylene Glycol (short non-reactive linker) Short Primer Probe F F Q PEG DNA

20 Long PROBE quickly “anchors” bringing the short PRIMER into close proximity with the DNA target PEG Probe Q F F DNA Short Primer

21 DNA Primer PEG Probe Q F F P P COOPERATIVITY between primer and probe increases reactivity, sensitivity and specificity DNA folds allowing our short primer to bind When POLYMERASE extends, the primer cannot cross the PEG linker, helping to reduce Primer Dimers

22 A short primer can easily bind once anchored. Probe Primer Probe Primer Probe Primer Probe Primer Probe Primer Probe Primer Specificity increases as BOTH primer & probe have to match and bind to their mathematically derived targets. Primer and Probe are interconnected to create more surface area. The probe is an anchor for the primer, amplifying primer’s reactivity 10,000x. COMBINING PRIMER & PROBE increases primer reactivity by 10,000 TIMES

23 Our software uses advanced algorithms to create CoPrimersOur software uses advanced algorithms to create CoPrimers –Primer & Probe linked together Compares thousands of possible designs to create optimized primer and probe combinations that cooperate with each other to increase accuracy.Compares thousands of possible designs to create optimized primer and probe combinations that cooperate with each other to increase accuracy.

24 p 1.Determine where in the genome to target 2.Create multiple cooperative primer designs a)minimum length of the primer for specificity b)optimal length of the probe c)space between primer & probe d)length of the linker (PEG tether), etc. 3.Compare effectiveness of different CoPrimer sets Advanced Mathematics are used to: F F Q PEGPEG Design A F F Q PEGPEG Design B

25 1.Linker is between ~12 bases long 2.Gap between primer and probe is ~5 bases 3.Allows the DNA to bend around CoPrimer Mathematically optimized CoPrimers Probe Primer 12 5

26 Peer Review

27 Our technology is based on our own innovations and patents with no external patent fees or royalty streams.

28 Faster, lower cost development.Faster, lower cost development. –Co-Dx Design software designs and optimizes tests signficiantly streamlining the design process. CoDx allows scientists to do in weeks what traditionally takes months or years. No patent fees or royalty streams.No patent fees or royalty streams. –Our products are based on our own innovations, trade secrets and patents, eliminating the need to pass on third party royalties to our clients. Royalties are often the highest cost of goods. Lower cost of goods.Lower cost of goods. –Our highly optimized platform combines all of the chemical components into a single low-cost, concentrated reagent that does not require a separate “Hot Start.” Dr. Satterfield holding a vial that contains 400+ assays

29 Indian govt. to spend $10B over next 5 yrs 20% of global TB infection in India alone Mid-range labs are our target CURRENTLY ROLLING OUT IN INDIA India Roll-Out

30 Our ISO-certified Co-DX TB assay is consistently a top performer among TB tests in both specificity and sensitivity. TUBERCULOSIS (Clinical trials were performed under the name: DNA Logix Smart TB)

31 Our India TB test has been optimized for use with the ABI Step ONE from Thermo-Fisher. Thermo-Fisher Life Technologies PCR Device

32 COGS Co-Diagnostics - < $1.00COGS Co-Diagnostics - < $1.00 –Reagent Cost - <$0.40 –Consumables - <$0.60 –Royalties – 0.00 COGS – Competitor - > $12.00*COGS – Competitor - > $12.00* –Reagent Cost - ~1.00 (est.) –Consumables - ~$6.00 (est.) –Royalties - ~5.00 (est. *Data confirmed by analysts and company’s annual report

33 Co-Diagnostics $3-$8.00 rangeCo-Diagnostics $3-$8.00 range –The Price Per Test with CoDx* assays goes down as efficiency and utilization goes up. Competitor - $17.00**Competitor - $17.00** –Sale Price is actually- $10.00 –$7 will be contributed by a humanitarian organization $7 Subsidy $17.00** $8.00 (includes equipment) $10.00 to India $3.00 (Test only)

34 World-class tuberculosis test – –outperforms ALL other PCR tests on the market Unique and protected intellectual property – –Two granted patents and three pending patents Impressive menu of tests already completed – –Tuberculosis, HIV, malaria, hepatitis B and C, dengue and chagas, and others. Publication inThe Journal of Molecular Diagnostics – –March 2014 Development of manufacturing capability, with several international product shipments to date

35 STD PanelSTD Panel –HPV, HIV, Gonorrhea/Chlamydia, etc. Hospital Acquired Infections (HAI’s)Hospital Acquired Infections (HAI’s) –MRSA, C. Diff, etc. Cancer, Genetic Markers and Rare Allele DetectionCancer, Genetic Markers and Rare Allele Detection Blood Bank Analysis PanelBlood Bank Analysis Panel

36 Completed ISO Certification DNA Logix Inc (our development company) has recently passed its ISO Certification audit. Allows us to apply for CE Mark in the EU for specific assays

37 Bringing molecular diagnostics to the people and places where it is needed most

38 Innovating Revolutionary New Molecular Diagnostics


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