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http://www.verichipcorp.com/pdfs/SENSORwhite07.pdf

1

AN INTEGRATED SENSOR SYSTEM FOR THE

DETECTION OF BIO-THREATS

FROM PANDEMICS TO EMERGING DISEASES TO

BIOTERRORISM

WHITE PAPER

07 MAY 2009

E. Carlson, Ph.D.

President and Chief Science Officer

RECEPTORS LLC

Suite 510 / MD 57

1107 Hazeltine Blvd.

Chaska, MN 55318

Voice:

FAX:

email: bc@...

WWW.RECEPTORSLLC.COM

EXECUTIVE SUMMARY

An integrated system for bio-threat

(pandemic, emerging diseases, bioterrorism)

detection must include stable, sensitive

and selective solutions for the capture and

analysis across the diverse spectrum of

threat agents. In addition, the ideal threat agent

detection and alert system should be

capable of both single and multiplexed analysis over

the range of toxins, viruses and

microbes that present the most significant hazards.

However, the products currently in the

marketplace fail to provide a comprehensive

solution and, most importantly, are not

stable or scalable. Moreover, these systems are

generally too specific as they are

targeted to a particular pathogen strain. Thus, long

development and approval cycles result

in market introductions that are considerably

post-threat and not adaptable to current

or emerging threats. There is a clear need for a

biothreat sensor system that spans the

range from surveillance and early warning of both

known and novel agents to multiplexed

diagnostics for rapid and broadly applicable

classification and characterization

during an outbreak event. RECEPTORS' AFFINITY

by DESIGN™ CARA™ platform

and VeriChip's signal transduction and RFID

communication expertise combine capture,

analysis, response and report into a stable,

scalable and threat selective platform

which will be developed into an integrated suite of

sensor products that cover the

bio-threat/biodefense spectrum.

2

OPPORTUNITY

Natural and human events combine to

produce a steady stream of biological threats to

health and safety. These threats range

from pandemic flu and multiple-resistant

pathogens like " MRSA "

(Staphylococcus aureus) to food borne salmonella and E. coli.

The diversity of sources, threats and

consequences produce a very challenging

environment for detection, diagnosis and

alert. More significantly, failure to meet the

detection and identification challenge

results in a range of consequences, from massive

food recalls and economic loss to

morbidity and mortality. To meet this challenge, a

wide variety of products have been

introduced ranging from single threat diagnostics to

prototype surveillance sensor systems.

However, these responses to the market have

limitations in stability and scalability

and, in particular, their dependence on inherently

unstable biological agents, like

antibodies, places severe limits on both their economics

and applications. Most importantly,

these products are generally targeted to a single

agent, which may not resemble the next

threat. Clearly, what is needed is a sensor

system that is stable and scalable to

meet the demands of an impending pandemic and

capable of spanning the range of

specificity from a generic pathogenic virus alert to a

multiplexed response and read-out for

continuous surveillance. The combination of

RECEPTORS' CARA platform and VeriChip's

signal transduction and communication

capabilities provides both the

technology and the expertise required to build an integrated

bio-threat sensor system.

STRATEGY

The spectrum of bio-agent defense ranges

from sampling and capture to delivery of a

diagnostic result via a sensor platform.

The bio-agent spectrum includes a very diverse

range of targets from protein toxins to

pathogenic viruses and microbes. The strategic

goal of this program is to build an

integrated suite of sensor products focused on bioagent

surveillance, identification and alert.

The product and market prototype system

will focus on the development of a

pandemic virus triage system (Figure 1) based on

critical virus sensors, especially

pandemic agents like H1N1 (SWINE FLU), H5N1

(BIRD FLU) and SARS. The triage system

will provide multiple levels of identification;

the first will identify the agent as

virus or non-virus, the second level will classify the

virus and alert the user to the presence

of pandemic threat viruses, and the third level will

identify the precise pathogen. Specific

commercialization goals will include Point-of-

Intercept to Point-of-Care, that is,

from field to healthcare, sensors.

TECHNOLOGY

RECEPTORS' AFFINITY by DESIGN™

technology (US Patent 7,504,364 " Methods of

Making Arrays and Artificial

Receptors " ; additional US and worldwide patents pending)

is based on an efficient and scalable

high-throughput approach to the discovery and

application of stable and selective

binding environments. Our SMART MATERIALS

products and applications are built on

our core competence of Surface Functionalization

for Selective Binding (Figure 2).

RECEPTORS' CARA™ discovery platform (Figure 3)

is efficiently directed to the

development of sensor products and applications (US Patent

7,469,076 " Sensors Employing

Combinatorial Artificial Receptors " ; additional US and

worldwide patents pending), especially

as applied to the closed-cycle sensing system with

its critical combination of a target

binding environment

3

Figure 1. Schematic of the pandemic

virus triage system. Three levels of threat

identification are integrated into the

diagnostic devide: confirmation of virus presence,

classification of the virus as a

pandemic-risk, identification of the specific virus.

CARA™ PLATFORM

FRACTIONATION

and

PURIFICATION

DIAGNOSTICS

and

SENSORS

DIRECT

CAPTURE

SYSTEMS

SMART MATERIALS

CORE TECHNOLOGY:

Surface Functionalization for

Selective Binding

Figure 2. RECEPTORS core technology and

application platforms.

Detection Classification

Identification

Clear

No No

Virus Yes Yes

Present?

Pandemic

Virus? Virus Type?

HxNy? SARS? . . . ?

Clear

Alert!

Sample

4

Figure 3. Schematic depicting RECEPTORS’

binding environment selection and sensor

development workflow. The

high-throughput nature of binding environment selection

and optimization to threat targets

enables rapid development of products designed to

address current and emerging pandemic

threats.

ISOLATION MEMBRANE

SAMPLE VIRUS PARTICLES

VIRUS BINDING ENVIRONMENT

COMPETITION/SIGNALING COMPONENT

SIGNAL TRANSDUCTION AND

COMMUNICATION ELECTRONICS

Figure 4. Closed-cycle sensing system.

Critical components include the binding

environments and the competitor agent.

SPIN COLUMNS;

CHROMATOGRAPHY COLUMNS;

AFFINITY SUPPORTS;

AFFINITY CHIPS; MICROARRAYS;

SENSORS; DIP STRIPS…..

CARA SENSING SYSTEM

CARA™ MICROARRAY DISCOVERY

TOOL

FROM HIGH-THROUGHPUT DISCOVERY TO

OPTIMIZED APPLICATIONS:

MICROARRAY

BINDING MAP:

SPECIFICITY AND

AFFINITY SELECTION

RESOURCE.

OPTIMIZED TIMELINES

5

with a competitor reagent. The sensing

system, as illustrated in Figure 4, can be targeted

to the products and applications

required for bio-threat detection and diagnosis, ranging

from Point-of-Intercept to Point-of-Care

(Figure 5) surveillance and diagnostic sensor

systems. The critical closed-cycle

sensing system has been proof-of-concept

demonstrated using a glucose sensing

system model. (Figure 6). This model is being

further developed into an integrated

system for in vivo glucose monitoring (Figure 7)

through incorporation of VeriChip's

signal transduction and RFID communication

technologies (US Patent 7,125,382;

" Embedded Bio-Sensor System " ). Our experience

with the glucose sensing system program,

in combination with our systems for the

application of our CARA high-throughput

screening platform, has established the

development workflow that will be

applied to this bio-threat development program.

PRODUCTS AND PROGRAM PLAN

This program will focus on the

development of pandemic flu sensors that can be applied

to both single-point (single target

virus) and multiplexed (multiple target virus) sensor

systems (as illustrated in Figure 5).

Specific products include:

PRODUCT: " YES/NO " , SINGLE-USE

SENSORS that will screen for single or

multiple target presence/absence.

PRODUCT: PANDEMIC SURVEILLANCE SENSOR

SYSTEM that will provide

multiplexed alert to a range of target

agents.

PROGRAM PHASE I. TARGET VIRUS SENSING

SYSTEM

There are several key components to

these products, the most critical of which are the

development of binding environment and

competitor pairs for each virus target (as in

FIGURE 4). The competitive interaction

of the target virus, the binding environment and

the competitor will produce a signal

that is proportional to the presence of the virus.

FIGURE 3 illustrates the general flow

scheme that is utilized by RECEPTORS to build

selective affinity environments for a

wide variety of applications. The critical steps in the

demonstration of the target sensing

system are development of the target virus selective

binding environment and the labeled

competition and signaling component. The steps in

this process, which will utilize

RECEPTORS' established CARA™ workflow and

sensing system competitor expertise,

will be repeated for each target virus:

-- Combinatorial preparation and

high-throughput screen selection of candidate

competitor agents.

-- CARA™ microarray-based

high-throughput screen selection of candidate binding

environments.

-- Combination and optimization of

binding environment and competition / signaling

component to demonstrate proportional

response to virus presence / absence.

-- Optimization of candidate binding

environments for target sensitivity and specificity.

PROGRAM PHASE II. SENSING SYSTEM AND

ELECTRONICS SIGNAL

TRANSDUCTION INTERFACE. The sensing

system developed in Phase I will provide

a target virus signal via the

competitive binding of the fluorescent or visibly labeled

competitor agent versus the target virus

to the virus selective binding environment.

Signal transduction will be via optical

to signal electronics with read-out and report. The

6

Virus Capture

Single-Target

Sensor

Multi-Target

Sensor

Figure 5. Schematic depicting biothreat

detection diagnostic systems.

Competitive

Binding

0

10000

20000

30000

40000

50000

60000

70000

Glucose Competition Series

Selected Titration Curves

G4.5-gluBB-647

0

10000

20000

30000

40000

50000

60000

0 100x 1000x 10000x 100000x

Increasing Glucose Concentration

Fluorescence Units

Tunable Glucose Response

Selection of Binding

Environment and Competitor

Agent Pairs

Figure 6. Glucose sensing system

proof-of-concept. Selection and optimization of

competitor agent – binding

environment pairs enables control over the glucose response.

7

Glucose Sensing

Component

Signal Transduction

Component

Figure 7. Illustration of an implantable

glucose sensor which houses an integrated

sensing system with signal transduction

and RFID communication capability.

V

V

V

V

V

V

V V

Sample

Sensor

Interface

System

Diagnostic Sensor Device

Sensor Reader Instrument

Sample OK!

Figure 8. Diagram of the integrated

virus sensor system which will include a single or

multiplexed virus sensing system,

optical signal transduction, and communication

electronics.

8

electronics package will be contained in

a base or hand-held instrument suitable for both

field and point-of-care applications (as

illustrated in Figure 8).

PROGRAM PHASE III. INTEGRATED SENSOR

DEVELOPMENT. The prototype

virus sensors will be produced by

integration of either single or multiplexed sensing

systems with optical signal transduction

that is coupled to the application specific, sensor

integrated circuitry and the

communication electronics (for example, Figure 8).

SELECTED REFERENCES

Morse, et.al., " Next Flu Pandemic:

What to do Until the Vaccine Arrives? " , Science, vol.

314, p. 929 (2006).

Criteria for Rapid Influenza Diagnostics

P. Lu, " Early Diagnosis of Avian

Influenza " , Science, vol. 312, p.337 (2006).

WHO Recommendations on the use of Rapid

Testing for Influenza Diagnosis, see

www.who.int/csr/disease/avian_influenza

Rapid Diagnostic Testing for Influenza,

see www.cdc.gov/flu.

Synthetic Receptors

Schader, T. and Hamilton, A.D. (Eds.)

Functional Synthetic Receptors, Wiley-VCH

Verlag GmbH & Co. KGaA (2005) 428pp.

Sensors

Narayanaswamy, R., Wolfbels, O.S.

(Eds.), Optical Sensors: Industrial, Environmental

and Diagnostics Applications, Springer (2004) 421 pp.

http://www.reuters.com/article/pressRelease/idUS151716+29-Sep-2009+BW20090929

VeriChip Corporation and RECEPTORS LLC Announce

Further Details of Development Plan for Virus Triage Detection System for H1N1

Virus

Tue Sep 29, 2009 11:47am EDT

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Technology Behind System Expected to Inexpensively Identify H1N1 Virus andIdentify New Strains of Viruses and Other Diseases Within MinutesDELRAY BEACH, Fla. & CHASKA, Minn.--(Business Wire)--VeriChip Corporation ( " VeriChip " ) (NASDAQ: CHIP) and its development partnerRECEPTORS LLC, a technology company whose AFFINITY by DESIGN chemistry platformcan be applied to the development of selective binding products, announced todayfurther details of the development of its virus triage detection system for theH1N1 virus. The virus triage detection system, based on RECEPTORS' patentedAFFINITY by DESIGN CARA platform, is intended to initially provide two levels ofidentification within minutes. Once developed, utilizing a simple test tube orstrip device format that can be combined with an inexpensive reader, it isexpected that the first level will prep the sample and identify the agent as aflu or non-flu virus, and the second level will sub-type (e.g. H1N1) classifythe flu virus and alert the user to the presence of pandemic threat viruses.Additionally, VeriChip believes the influenza triage diagnostic system will bescalable and will be able to be rapidly adapted to identify new strains ofinfluenza and other viruses as they evolve, giving the virus triage detectionsystem value for future testing applications in healthcare. The first phase of development of the virus triage detection system, consistingof the sample prep and flu or non-flu classification, is expected to becompleted in four months. The second phase of the triage detection system, whichwill have the ability to identify the precise pathogen present, is expected totake approximately six to eight months. The current gold standard for influenza sub-type identification relies on eithera polymerase chain reaction test or culture approach, neither of which is aquick (or inexpensive) test. The current crop of quick test products on themarket is only capable, due to limitations in their technology platform, ofproviding a yes/no answer to the presence of influenza. RECEPTORS' influenza triage diagnostic system will use a multiplexed read-out(multiple end-points that can be read in a single scan) to produce a fingerprintthat will both detect the presence of influenza virus and identify the specificinfluenza sub-type (e.g. pandemic H1N1 versus seasonal sub-types). Moreover,this test will be in a simple test tube or strip device format that can becombined with an inexpensive reader to give a quick test result, ideally in lessthan 10 minutes. E. Carlson, Ph.D., President and Chief Science Officer at RECEPTORS LLC,said, " Our multiplexed, fingerprint read-out technology is critical to thedevelopment of a successful seasonal and pandemic influenza diagnostic productfor two main reasons. First, the time to produce an H1N1 specific quick testusing the current technologies and methods is too long for effective use duringthis pandemic. Second, the next pandemic flu will almost certainly be a new ormodified influenza strain (HxNy), making any of the current quick testdiagnostics that might be directed to a particular flu sub-type obsolete ormarginally effective, or both. RECEPTORS' influenza triage diagnostic system canbe rapidly adapted to identify the new strain of virus while still keeping thecurrent identifications through the simple measure of establishing andvalidating a new multiplexed read-out pattern/fingerprint for the emergingthreat. Put simply, our technology and its application do not limit us to thedetection of the H1N1 virus. This technology can be quickly and effectivelyapplied to detect any pandemic virus or biological agent. " Verichip's and RECEPTORS' AFFINITY by DESIGN technology (US Patent 7,504,364 " Methods of Making Arrays and Artificial Receptors " ; additional US and worldwidepatents pending) is based on an efficient and scalable high-throughput approachto the discovery and application of stable and selective binding environments.Its SMART MATERIALS products and applications are built on its core competenceof Surface Functionalization for Selective Binding. RECEPTORS' CARA discoveryplatform is efficiently directed to the development of sensor products andapplications (US Patent 7,469,076 " Sensors Employing Combinatorial ArtificialReceptors " ; additional US and worldwide patents pending), especially as appliedto the closed-cycle sensing system with its critical combination of a targetbinding environment with a competitor reagent. On September 16, 2009, VeriChip announced its plans to fund its existingpartnership with RECEPTORS to continue the development of a triage detectionsystem for detection of the H1N1 virus. On September 21, 2009, VeriChipannounced it was granted an exclusive license to RECEPTORS' Patent No. 7,504,364and Patent No. 7,469,076 in their application to the development of the virustriage detection system for the H1N1 virus. The companies published a white paper entitled, " An Integrated Sensor System forthe Detection of Bio-Threats from Pandemics to Emerging Diseases toBioterrorism, " which is available at www.verichipcorp.com. About RECEPTORS LLC RECEPTORS LLC develops SMART MATERIALS products for laboratory, clinical,industrial hygiene and healthcare use that selectively capture and measurechemical, biochemical and cellular targets from complex biological,environmental or industrial samples. The Company's patented AFFINITY by DESIGNplatform has broad applicability, ranging from the isolation of disease pathwayproteins for drug discovery and production of therapeutic antibodies, to thecapture of bacteria and viruses for disinfection and diagnostic purposes.RECEPTORS LLC is a private company based in suburban Minneapolis, Minnesota. Forfurther information please visit http://www.receptorsllc.com. About VeriChip Corporation VeriChip Corporation, headquartered in Delray Beach, Florida, has developed theVeriMed Health Link System for rapidly and accurately identifying people whoarrive in an emergency room and are unable to communicate. This system uses thefirst human-implantable passive RFID microchip and corresponding personal healthrecord, cleared for medical use in October 2004 by the United States Food andDrug Administration. On September 8, 2009, VeriChip Corporation announced it agreed to acquire SteelVault Corporation (OTCBB: SVUL) to form PositiveID Corporation. PositiveID willprovide identification technologies and tools to protect consumers andbusinesses. The companies expect the merger to close in the fourth quarter of2009. For more information on VeriChip, please call 1-, or e-mailinfo@.... Additional information can be found online atwww.verichipcorp.com. Statements about VeriChip`s future expectations, including its development of atriage detection system, the expectation that the triage detection system, ifdeveloped, will function as intended and be a marketable product, the beliefthat the influenza triage diagnostic system will be scalable and could beadapted to identify new strains of influenza and other viruses as they evolve,giving the virus detection triage system value for future testing applicationsin healthcare,the expectation regarding the timing of the first and secondphases of the virus triage detection system, the expectation that the nextpandemic flu will almost certainly be a new or modified influenza strain (HxNy),and all other statements in this press release other than historical facts are " forward-looking statements " within the meaning of Section 27A of the SecuritiesAct of 1933, Section 21E of the Securities Exchange Act of 1934, and as thatterm is defined in the Private Litigation Reform Act of 1995. Suchforward-looking statements involve risks and uncertainties and are subject tochange at any time, and VeriChip`s actual results could differ materially fromexpected results. These risks and uncertainties include the Company`s ability tosuccessfully develop and commercialize the virus triage detection system, themarket acceptance of the virus triage detection system, the Company's ability todevelop a virus triage detection system that is scalable and capable of beingrapidly adapted to identify new strains of influenza, the validity, scope andenforceability of RECEPTORS LLC`s patents and those related to the virus triagedetection system, the protection afforded by RECEPTORS LLC`s patents and thoserelated to the virus triage detection system, the effect of changes andconditions relating to new influenza strains and influenza pandemics, theCompany's ability to complete the development phases in the expected timeframes, government regulations relating to the virus triage detection system,the Company's ability to fund the continued development of the virus triagedetection system; the timing and success of submission, acceptance and approvalof required regulatory filings; as well as certain other risks.Additionalinformation about these and other factors that could affect the Company`sbusiness is set forth in the Company`s various filings with the Securities andExchange Commission, including those set forth in the Company`s 10-K filed onFebruary 12, 2009, under the caption " Risk Factors. " The Company undertakes noobligation to update or release any revisions to these forward-lookingstatements to reflect events or circumstances after the date of this statementor to reflect the occurrence of unanticipated events, except as required by law. Additional Information and Where to Find It On September 8, 2009, VeriChip and Steel Vault issued a joint press releaseannouncing the signing of an Agreement and Plan of Reorganization, amongVeriChip, Steel Vault and VeriChip Acquisition Corp., a Delaware corporation andwholly-owned subsidiary of VeriChip (the " Acquisition Subsidiary " ), pursuant towhich the Acquisition Subsidiary will be merged with and into Steel Vault, withSteel Vault surviving and becoming a wholly-owned subsidiary of VeriChip (the " Merger " ). Upon the consummation of the Merger, each outstanding share of SteelVault`s common stock will be converted into 0.5 shares of VeriChip common stock. In connection with the Merger, VeriChip filed with the Securities and ExchangeCommission ( " SEC " ) a Registration Statement on Form S-4 that will contain aJoint Proxy Statement/Prospectus of VeriChip and Steel Vault. Investors andsecurity holders are urged to read the Registration Statement and the JointProxy Statement/Prospectus carefully because they contain important informationabout VeriChip, Steel Vault and the proposed transaction. The Joint ProxyStatement/Prospectus and other relevant materials (when they become available),and any other documents filed with the SEC, may be obtained free of charge atthe SEC`s web site (www.sec.gov). In addition, investors and security holdersmay obtain a free copy of other documents filed by VeriChip or Steel Vault bydirecting a written request, as appropriate, to VeriChip at 1690 South CongressAvenue, Suite 200 Delray Beach, Florida 33445, Attention: Investor Relations, orto Steel Vault at 1690 South Congress Avenue, Suite 200 Delray Beach, Florida33445, Attention: Investor Relations. Investors and security holders are urgedto read the Joint Proxy Statement/Prospectus and the other relevant materialsbefore making any voting or investment decision with respect to the proposedtransaction. VeriChip, Steel Vault and their respective directors and executive officers maybe deemed to be participants in the solicitation of proxies in connection withthe proposed transaction. Information regarding the interests of these directors and executive officers inthe proposed transaction will be included in the Joint ProxyStatement/Prospectus referred to above. Additional information regarding thedirectors and executive officers of VeriChip is also included in VeriChip's Form10-K, which was filed with the SEC on February 12, 2009. Additional informationregarding the directors and executive officers of Steel Vault is also includedin Steel Vault's proxy statement (Form DEF 14A) for the 2009 annual meeting ofSteel Vault's stockholders, which was filed with the SEC on February 9, 2009, asamended. These documents are available free of charge at the SEC`s website(www.sec.gov) and by contacting Investor Relations at the addresses above. VeriChip Corporation Tomek, atomek@... Copyright Business Wire 2009

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