GenPrime Investor Presentation

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Innovations for a Secure and Healthy World

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Core Technologies

• Core technologies in multiple industries

Cheese Dairy
Water Beverages
1999
2006
GenPrime Technologies
Rapid
Microbe Detection
(Broad Patent
Protection)
Founded 1997
Fermentation
Blood Products
2000
2005
Homeland Security
2002
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Platelet Contamination
               
Bacterial Contamination of Platelets is a Major
Concern to the Medical Community
AABB Standard 5.1.5.1 requires bacterial testing
on every platelet unit (100 QC)
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Industry Requirements
Blood Banks Hospitals Need
Robust Bacterial Assay

• Rapid
• Sensitive
• Cost-effective
• User-friendly
• Computer interface capability

Of the current methods, the rapid
assays are not sensitive and the sensitive assays
are not rapid.
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Current Methods
Bacterial Detection in Platelets

• Method Sensitivity
• Staining/microscopy 106 cfu/ml
• Dipsticks pH glucose 107 cfu/ml
• Swirling 107 cfu/ml
• O2 consumption Pall eBDS lt102 cfu/ml
• CO2 generation BacT/ALERT lt102 cfu/ml

Rapid (No Culture required)
Slow (Culture required)
Additional methods are under development
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GenPrime's Approach
GenPrime Expanded its Antibody Technology
to Develop a Rapid Bacterial Test - BacSTAT

• Broad-spectrum antibody-based lateral flow
  device for detection of bacteria in apheresis
  or whole blood derived platelets
• Unique lateral-flow scanning system
• Pass/Fail software system

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GenPrimes Technology
               
Broad-Spectrum Antibody Detection of Bacteria
Unique Bar Code
Control Line
(pos)
A single lateral-flow antibody
strip detects all 14
contaminating organisms.
(neg)
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Platelet Bacteria
Target Organisms Target
Sensitivity
S. epidermidis   S. aureus   B. cereus   B.
subtilis  Ps. aeruginosa   Streptococcus
viridans/mitis   Streptococcus pyogenes  E. coli
  Klebsiella oxytoca  Serratia marcescens
  Enterobacter cloacae   Corynebacterium
xerosis  Propionibacterium acnes  Clostridium
perfringens  
103 cfu/ml
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Bacterial Detection
               
Preliminary Data with BacSTAT
Current sensitivity for detection of E. coli in
platelets is 104 cfu/ml.
107 106 105 104 103
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Assay Method
The Assay is Simple and Rapid
Total Test Time is Less Than 20
Minutes
1 ml Platelet Sample
Run Lateral-Flow Strip
Scan and Log Data
Sample Prep
(lt 1 min)
(3 min)
(15 min)
(lt I min)
Multiple tests can be carried out simultaneously.
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BacStat
BacSTAT Detects Bacteria with Objective Results
Rapid Lateral-Flow Scanner
The BacSTAT employs pass/fail threshold software
to determine if platelets
are contaminated.
Antibody Strips
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Validation for FDA
Validation Plan for BacSTAT as QC Indication

• Sensitivity
• Spiking studies in platelets
• Test all 14 bacteria (aerobic and anaerobic)
• Evaluate 10 samples for each concentration
  (10/10 detection limit)
• Compare to Predicate Device
• Spike platelets at 1 cfu/ml and collect samples
  at 24 hour intervals
• Test each sample with BacSTAT, plate count and
  either BacT/ALERT or eBDS
• 
  
  Potential
  issues Low spiking level and some bacteria may
  not grow in platelets

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Conclusion
BacSTAT is a robust bacterial detection test for
the QC of whole blood and apheresis
platelets prior to transfusion.

• Simple - Dipstick format
• Rapid - Total time less than 20 minutes
• Sensitive - 103 cfu/ml
• Automated Data Tracking

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Jim Fleming Chief Technology Officer jfleming_at_genp
rime.com 866-624-9855