Mosaic 545 - Infinity Medical Engineering

Transcription

Mosaic 545™
Pathogen Diagnostic Technology Platform
Immunotrex Biologics, Inc
Syed K. Hasan M.D. Ph.D. – CEO/President Immunotrex
Michael McDaniel – CEO/President Infinity Medical Engineering
Immunotrex Biologics, Inc.
Infinity Medical Engineering, LLC
© 2014 Immunotrex Biologics
Mosaic 545™
Pathogen Diagnostic
Technology Platform
Overview
Infectious Disease Control Imperative
Mosaic 545 Pathogen Identification
Diagnostic Procedure
Pathogen Identification Mechanism
Mosaic 545 Prototype Design
Contract Manufacturing Associates
Intellectual Property
2/26/2014
2
INFECTIOUS DISEASE
CONTROL IMPERATIVE
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Federal Public Health Mandate – Global Intervention
Infectious disease is a growing global health threat. As recently as two weeks ago,
Health and Human Services Secretary Kathleen Sebelius launched a global effort to
“prevent, detect and respond to infectious disease threats where they start”. (Global
Health Security Agenda).
Infectious disease epidemics originate largely in
developing countries. The United States is
susceptible to infectious disease transmission by
virtue of the increased mobility and interaction of
global populations. Human immunodeficiency
virus (HIV) serves as a potent reminder.
The United States occupies a lead position as a
“first responder” to humanitarian crises
throughout the world, including infectious
disease outbreaks. The ability to diagnose a
patient quickly and accurately is critical to
containing an outbreak.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Federal Public Health Mandate – Domestic Healthcare
The incidence of opportunistic, secondary infection in
primary care facilities is increasing at an alarming rate.
The costs in patient morbidity and treatment are
straining the national healthcare system.
A report published in the Journal of Emerging
Infectious Diseases, found a 90% increase in reports of
MRSA infections among U.S. hospital outpatient
admissions from 1999-2006.
A 2009 Center for Disease Control study review
examining the costs of healthcare associated infections
in hospitals estimated the excess hospital cost of
healthcare associated infections in the US to be
between 28 and 45 billion dollars annually.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Federal Public Health Mandate – National Security
In addition to existing and potential infectious disease outbreaks
attributable to spontaneous environmental origin, it is incumbent
upon the United States to maintain a robust, comprehensive
prophylaxis and agile emergency response strategy to combat the
possibility of a biological attack.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Federal Public Health Mandate – Improved Patient Care
In each scenario “time to diagnosis” is critical.
Rapid diagnosis facilitates:
 Identification and quarantine of infected patients
 Identification of the infectious agent/pathogen
 Administration of the appropriate treatment regimen
 Reduction in duration of symptoms and improved prognosis
 Reduction in patient length of stay
Faster diagnosis, prompt and appropriate medical treatment and
reduced duration of hospital stay improve patient quality of life,
reduce health care expense and facilitate increased access to
immediate care facilities.
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MOSAIC 545
PATHOGEN
IDENTIFICATION
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Current “State of the Art” –
Blood Culture for pathogen identification
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Time is Critical
When a patient presents with an infection during emergency or
intensive care, blood culture can be a race against time.
The typical process of pathogen identification
in blood takes at least 24 hours.
Current methods include culture techniques
using agar plates and culture mediums (c. early
1900s) prolonging the process of identification.
Culture methods are dependent on producing
additional infectious pathogen.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Introducing Mosaic 545™
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Real-time positive pathogen identification (< 10 minutes)
Sterile, self-contained cartridge
Simple on-site use model
Multiple samples run simultaneously
No culturing of infectious pathogens
MOSAIC 545™ utilizes highly conserved
species specific oligomer hybridization of
small RNA sequences.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Mosaic 545™ Components
 Sterile, self-contained pathogen
identification cartridge
 Multi-slot cartridge reader
 Signal processing software
Pathogen
Identification
Cartridge
Cartridge
Reader
Signal Processing
Software
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Mosaic 545™ Pathogen Identification Cartridge
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
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The Pathogen
Identification cartridge
is the heart of the
Mosaic 545.
Retractable injector for specimen acquisition
Cartridge is self-contained and sterile
All reagents and specimen quarantined
Pathogen filtration and rRNA isolation
Customizable to localized infectious agents
Specimen processing eliminates pathogen viability
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Mosaic 545™ Cartridge Reader
 On-site, immediate, “plug and play”
processing
 Barcode on cartridge corresponds to
patient ID
 Simultaneous processing of multiple
cartridges
 Economical— significantly lower
cost per test
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DIAGNOSTIC
PROCEDURE
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Specimen Is Collected
Specimen collection is
performed by a trained
phlebotomist, medic, or
first responder in
accordance with standard
healthcare best practices.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Specimen Is Injected into Cartridge
The Mosaic 545 cartridge
has an integral, positive
lock injector.
The technician engages
injector and inserts it into
specimen collection tube.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Cartridges Are Inserted into Cartridge Reader
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
A technician inserts
the cartridges into
the cartridge reader.
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PATHOGEN
IDENTIFICATION
MECHANISM
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Targeted Pathogens and Diseases
Bacterial Pathogen
Bartonella henselae
Cat scratch disease
Borrelia burgdorferi
Lyme disease
Brucella (species)
Brucellosis
Chlamydia psittaci
Psittacosis
Clostridium botulinum
Botulism
Clostridium perfringens
Εpsilon Toxin (ε)
Cryptosporidium parvum
Cryptosporidiosis
Escherichia coli O157:H7
Food poisoning
Rickettsia prowazekii
Typhus fever
Salmonella (species)
Typhoid fever, food
poisoning
Shigella dysentariae
Severe dysentery
Staphylococcus aureus
Streptococcus pneumoniae
Vibrio cholerae
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Disease
Septic shock
Multiple, meningitis
Cholera gravis
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The Target: Ribosomal RNA
Monoclonal Antibody
affinity sensors in the
cartridge target highly
conserved ribosomal
RNA (rRNA) for each
pathogen.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Mosaic 545 Component Functions
The specimen is filtered, bacteria is lysed, and conserved
ribosomal RNA (rRNA) sequences are exposed to reduced
graphene oxide (RGO) and fluorescence sensors coated with
specific affinity monoclonal antibody mAb.
Pathogen
Identification
Cartridge
Cartridge
Reader
Signal Processing
Software
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
An internal control validates the cartridge prior to processing.
Impedance and fluorescence at each sensor are continuously
monitored. The multi-bay cartridge reader can process up to
12 cartridges simultaneously in less than 10 minutes.
Pathogen
Identification
Cartridge
Cartridge
Reader
Signal Processing
Software
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Raw data from the cartridge monitoring process is sent
directly to a PC. Signal processing identifies valid sensor
signals and specific pathogen(s). The specimen bar code links
the data to the patient record. Results are transmitted via
multiple communication portals.
Pathogen
Identification
Cartridge
Cartridge
Reader
Signal Processing
Software
Pathogen
Identification
Cartridge
Model: _______
Lot # _________
Specimen ID:
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Mosaic 545™ Cartridge Schematic
CTRL
Electric
Terminals
Bimodal Sensor
Assembly
rRNA –
Antibody
Affinity
Binding
Chamber
Selective Filters
Sample Injector
(Retractable)
Lysis Chamber
Sample Reservoir
Saline
Lysis Solution
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Blood Sample Components
White Blood Cells (7-20 µm)
Decreasing Size
Red Blood Cells (6-8 µm)
Bacteria (3-10µm)
Ribosomes, Proteins (<1 µm)
Nucleic Acids (nm)
(Images not to scale)
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Intra-Cartridge Specimen Processing
Within the Pathogen Identification cartridge:
1)
The specimen is filtered, excluding components > 10µm;
bacteria pass through the filter.
2)
The pathogenic bacteria are lysed, releasing cellular
components, including targeted ribosomal RNAs (rRNAs).
3)
The specimen is filtered, removing lysis debris >1µm;
proteins, ribosomes and nucleic acids pass through the
filter.
4)
Specimen rRNAs are exposed to multiple reduced
graphene oxide (RGO) sensors, each coated with a unique
specific affinity monoclonal antibody.
10 µm Filter
Target rRNA
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
1)
2)
3)
The specimen is filtered, removing lysis debris >1µm;
filter.
4)
< 1 µm Filter
Target rRNA
10 µm Filter
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Target rRNA
1)
2)
3)
The specimen is filtered, removing lysis debris > 1µm;
filter.
4)
< 1 µm Filter
Ribosome
Protein
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
1)
2)
3)
filter.
4)
Target rRNA
Nucleic Acids
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Target rRNA
2/26/2014
1)
2)
3)
filter.
4)
mAb binds
target rRNA
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MOSAIC 545™
PROTOTYPE DESIGN
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Bacterial Pathogens
Nominal Size
Bacterial Pathogen
Bartonella henselae
0.5
1.0
0.2 – 0.3
10 - 30
Brucella (species)
0.6 - 1.5
2 - 10
0.5
--
0.3 - 1.9
2 - 10
0.5 - 5.0
5
4.2 - 6.5
4.5 - 7.9
0.25 - 1.0
3.0
0.3
1.0
0.3
3
0.4 - 0.6
1.0 - 3.0
0.5 - 0.8
--
0.5 – 1.25
--
1.0
2-3
Chlamydia psittaci
Electron micrograph - S. aureus, the
strain responsible for MRSA
Vibrio cholerae
2/26/2014
Diameter (µ) Length (µ)
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Sensor Function
The baseline impedance of each sensor is established prior to sample
processing. At this point, the specimen is intact, and no antibody
binding has occurred.
The Mosaic 545 monitors the impedance across each sensor
continuously in real-time, detecting and identifying changes resulting
from antibody-pathogen binding.
Localized sensor fluorescence is measured, confirming binding
interaction at the sensor.
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Bimodal Sensor Assembly
Impedance Sensor
Fluorescence Sensor
mAb-coated
RGO
Targeted rRNA binding increases
electrical impedance through
mAb-coated reduced graphene
oxide (RGO) sensor.
Fluorophore emission from rRNA-mAB
binding confirms impedance sensor
identification of pathogen.
Resonant
frequency
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Change in resonance due to
introduction of pathogen
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Impedance Sensor
Nucleic Acids
(+)
Target rRNA
Monoclonal
Antibody
(-)
mAb + rRNA
mAb-coated RGO
(Reduced Graphene Oxide)
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Fluorescence Sensor
Fluorescence
(+)
Target rRNA
Monoclonal
Antibody
(-)
mAb + rRNA
mAb-coated RGO
(Reduced Graphene Oxide)
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Mosaic 545™ Cartridge – BARDA Pathogen Profile
CTRL
1.
2.
3.
4.
5.
6.
7.
Brucella (species)
Chlamydia psittaci
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1
8
2
9
3
10
4
11
5
12
6
13
7
14
8.
9.
10.
11.
12.
13.
14.
Vibrio cholerae
Bartonella henselae
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Multi-Slot Cartridge Reader
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“Plug and play”—Technician inserts
cartridge(s) into Mosaic 545 card reader
and initiates the processing run.
Cartridge is validated prior to processing
specimen.
Current design offers 12 cartridge slots —
processes up to 12 samples
simultaneously, in < 10 minutes.
Bar code reader syncs test result to
patient.
Multiple data transmission options—to
PC, wireless network, Radio Frequency
Identification (RFID), onboard LCD display,
Short Message Service (SHS), Multimedia
Messaging Service (MMS)
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Signal Processing Software
Mosaic 545 combines well established scientific elements with
cutting edge technologies to identify the presence of pathogens
at a sub-specific (strain) level. The mechanism of detection is
two-fold:
I. Change in impedance across a reduced graphene
oxide (RGO) sensor
II. Optical measurement of fluorescence emission
Changes are due to specific ribosomal RNA (rRNA) – monoclonal
antibody (mAb) binding. The sensor array is coded and activated
sensor(s) identify the pathogen(s).
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Traditional Culture vs. Mosaic 545
Features
Traditional Culture Methods
Mosaic 545™
Speed
24 – 48 hours
5 – 10 minutes
Safety
Incubation, growth, and handling of
specimen pathogen; complex
disposal process
Specimen pathogen
quarantined and destroyed;
simple disposal of cartridge
Simplicity
Multi-step protocol
Unitary cartridge processing
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Contract Manufacturing Associates
Immunotrex has pending proposals from two contract manufacturing firms:
 Enercon Technologies, Inc. for development of the Mosaic 545 cartridge and
multi-bay reader
 Precision Antibodies, Inc. for custom monoclonal antibodies
Submitted proposals include pilot program development through to multiple
working prototypes for internal and external testing. Time to completion of
prototype – 6 months from project initiation. Immunotrex maintains all rights to
any and all contracted works.
Enercon Technologies, Inc. – Gray, ME

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ISO 13485:2003
FDA Registered
21 CFR Part 820 GMP
ISO 9001:2008
ESD S20.20
UL, ETL, TUV
2/26/2014
Precision Antibody™, Inc. – Columbia, MD
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AAALAC accredited
Custom mAb development
“One Stop Shop”
FDA, NCI, EPA contractor
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Intellectual Property
• US Patent Application Serial No. 13/894,971 (Newly Filed)
• Continuation Application of USSN 12/426,470
• Title: METHODS FOR MICROORGANISM DETECTION AND
IDENTIFICATION
• M&G Ref: 40819.0001USC3
2/26/2014
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Mosaic 545™
Pathogen Diagnostic
Technology Platform
Thank You
Immunotrex Biologics appreciates the opportunity to
present our Mosaic 545™ pathogen diagnostic technology
platform.
Questions ?
2/26/2014
44

Mosaic 545 - Infinity Medical Engineering

Transcription

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