OraSure 8K Regulation FD Disclosure | OSUR 28 Nov 07

OraQuick

ADVANCE

Histofreezer

OraSure

Intercept

NASDAQ ANALYST DAY

November 28, 2007

OraSure Technologies, Inc.

Exhibit 99.1

Forward-Looking Statements

These slides and the associated presentation contain certain

forward-looking statements, including statements with respect

to revenues, earnings, technology, new products, product

performance, markets, regulatory filings and approvals, and

business plans. Factors affecting these statements include,

but are not limited to, the ability to develop new technology,

technology changes, ability to fund research and

development, required regulatory approvals, product

performance and market acceptance of products. Please see

the Company’s SEC filings, including its registration

statements, and the Company’s most recent Form 10-K and

Form 10-Q, for a more detailed description of specific factors

that may cause actual results or events to differ materially

from those described in the forward-looking statements. The

Company undertakes no duty to update these statements.

AGENDA

Analyst Day

Wednesday, November 28, 2007

11:30 –

11:35 am

Introduction –

Doug Michels, President & CEO

11:35 –

12:30 pm

Stephen R. Lee, Ph.D. –

EVP & Chief Science

Officer

12:30 –

12:45 pm

Lunch

12:45 –

1:30 pm

Sue Sutton-Jones –

SVP of Regulatory Affairs &

Quality Assurance

1:30 –

2:00 pm

Joseph E. Zack –

EVP, Marketing and Sales

2:00 –

2:15 pm

Break

2:15 –

2:45 pm

P. Michael Formica –

EVP Operations

2:45 –

3:00 pm

Wrap-up

2007 –

Confidential and Proprietary

Research & Development Overview

Stephen R. Lee Ph.D.

Chief Science Officer

2007 –

Confidential and Proprietary

In Process Research & Development

•

Develop

and

commercialize

OraQuick

HCV

•

Develop oral fluid substance abuse test (SAT)

applications for high throughput laboratory

systems

•

Extend

the

shelf

life

OraQuick

ADVANCE™

HIV Test

•

Clinical

and

Regulatory

Studies

for

OraQuick

HIV OTC

•

Label expansion of OTC cryosurgery

indications

2007 –

Confidential and Proprietary

Hepatitis C Virus Infection

Statistics (United States)

New infections per year

30,000 –

40,000

Persons infected (1.6%)

4.1 million

Chronic infection

3.2 million

More than half of HCV cases are currently undiagnosed

Persons with HIV co-infection

225,000

Growing healthcare burden

–

50% of chronically infected individuals develop progressive

liver disease

–

HCV infection is the leading cause of all liver transplants

–

10,000 deaths/year attributable to complications of HCV

infection

Sources:

Armstrong

al.

(2006)

Ann.

Intern.

Med.

144:705-714

Scott

Gretch

(2007)

JAMA

297:724-732

2007 –

Confidential and Proprietary

Risk Factors Associated With

Acquiring Hepatitis C Virus

Past or present injection drug use

Transfusion, transplant from infectious donor

Infected sex partner(s)

Birth to an infected mother

Occupational blood exposure (needle sticks)

Tattooing/body piercing

Renal dialysis

2007 –

Confidential and Proprietary

Rationale for the Utility of a Rapid, Point-of-Care

(POC) Test to Aid in Identification of HCV Infection

•

Clear unmet need for increased diagnosis of Hepatitis C as

recognized by many Public Health entities including CDC.

•

Deployment of a rapid POC test will enable increased testing

for HCV, particularly in accessing those populations at greatest

risk.

•

HCV testing in many public health settings is limited due to the

requirement to draw blood for laboratory based testing.

•

As with HIV, POC testing for HCV will be particularly applicable

in settings where the target population is transient, or where

return adherence for results is low.

•

Current and future improvements in therapy mean that

increased diagnosis will be a critical factor in reducing overall

morbidity and mortality.

2007 –

Confidential and Proprietary

TEST

COLLECT

99.6%

100.0%

Oral Fluid

Venipuncture

Whole Blood

Plasma &

Serum

Fingerstick

Whole Blood

A Simple Test Procedure Utilizing

All Sample Types

MIX

2007 –

Confidential and Proprietary

Prototype OraQuick

HCV Test-

Interpretation

Non-reactive:

Single

line

appears

the C (control) triangle

•

A negative result indicates the

absence of target antibodies in the

sample.

Reactive for anti-HCV:

Two lines appear

•

One at the C (control) triangle

and the other at the T (test)

triangle

•

Indicates the presence of target

antibodies in the sample.

2007 –

Confidential and Proprietary

Sensitivity of the Prototype OraQuick

HCV Test in Known Infected Individuals

100%

Chronic HCV Infection

100%

HIV/HCV Coinfected

Patients

100%

466

HCV (RIBA) Positive

Plasma Donors

100%

Intra-venous Drug Users

Sensitivity

(%)

No. Reactive by

OraQuick

Specimen Type

Plasma Specimens

*No. of EIA reactive specimens tested

Lee SR et al. AACC, 2007

Source:

Lee

al.

AACC,

2007

2007 –

Confidential and Proprietary

Comparison of HCV Seroconversion

Sensitivity of OraQuick

HCV Prototype

with EIA

3.2

(1.4 to 5.1)*

47.5

50.7

Differential

Sensitivity

(Avg. Days

Detected

Earlier by

OraQuick

)

Average

Time To

Detection

by HCV

OraQuick

(Days)

Average

Time To

Detection

by HCV

EIA

(Days)

Number

Detected

Earlier by

OraQuick

Number

Detected

Earlier by

HCV 3.0

EIA

Number

Giving

Concordant

Results

Number

Panels

Tested

* 95% Confidence Intervals

Lee SR et al. AACC, 2007

Source:

Lee

al.

AACC,

2007

2007 –

Confidential and Proprietary

Sensitivity in Known HCV Positive

Subjects Tested Using Oral Fluid

and Whole Blood

92 (100%)

No. Detected by

OraQuick

HCV

(Oral Fluid)

No. Detected by

OraQuick

HCV

(Whole Blood)

No. Detected by

HCV EIA

No. of HCV

Positive

Subjects

Source:

Lee

al.

AACC,

2007

2007 –

Confidential and Proprietary

HCV ELISA

415

Preliminary

Performance

Data

from

the

OraQuick

HCV

Prototype in Oral Fluid Samples Paired with Blood, Plasma

& Serum: Low Risk Individuals (n=419)

a: RIBA 3.0 positive

b: RIBA 3.0 indeterminate

Subjects gave concordant results when tested with all 5

specimen types (serum, plasma, FS blood, VB, oral fluid)

Specificity= 99.8% (95% CIs: 98.7-100%)

Source:

Lee SR et al. AACC, 2007

2007 –

Confidential and Proprietary

HCV Prototype:

Additional Study Findings

•

Verified use of multiple anti-coagulants (EDTA,

citrate, heparin): No interference noted

•

Tested with worldwide genotype panel: Detected

all major genotypes and subtypes

•

Tested specimens with potential interfering

serology (HAV, HBV, HIV, HTLV, HSV, Syphilis,

Toxoplasmosis, CMV etc): No cross-reactivity

2007 –

Confidential and Proprietary

OraQuick

Rapid HCV Test Timeline

Preclinical development completed and prototype design

complete

Technology transfer complete and prototype produced at

scale in manufacturing facility

Clinical study protocols complete and study sites selected

Planned trials support CLIA waiver and submission for

CE mark

Clinical studies expected to start end of this year and

continue through Q1 ‘08

US regulatory filings are targeted for middle of next year

2007 –

Confidential and Proprietary

Rationale for Developing High Throughput

Automated Assays with Oral Fluid

•

Market adoption of oral fluid testing is increasing

•

Microplate systems are more labor intensive than current

fully automated systems

•

Microplate systems do not perform random access testing,

but test in “batch”

mode

•

Medium and large sized reference labs all use automated

systems for urine testing

•

Offering oral fluid applications on fully automated systems

will combine the convenience of an oral fluid sample with

the increased efficiencies of full automation

2007 –

Confidential and Proprietary

Roche-OraSure Collaboration

Combining Proven Expertise

OraSure Value

–

Oral fluid market leader

–

Extensive device

development expertise

–

Assay/ Applications

experience with oral fluid

–

Ref. Lab partner network

Roche Value

–

Leadership in DOA

testing market

–

Extensive assay

development expertise

–

Automated systems

experience

–

Large scale manufacturing

capabilities

2007 –

Confidential and Proprietary

The Intended Result for

Both Organizations

Generation of world class oral fluid assays

Faster time to market by combining expertise

Maintain leadership positions in the WW DOA

testing market

Maintain differentiation from competition

Ongoing collaboration in collection devices and

assays –

menu expansion

2007 –

Confidential and Proprietary

High Throughput SAT Assays-

Initial Launch Menu

•

Cocaine

•

Opiates

•

THC (Marijuana)

•

Amphetamines/Methamphetamines

•

Phencyclidine (PCP)

Required panel of drugs to be tested according to

guidelines from National Institute of Drug Abuse

2007 –

Confidential and Proprietary

Progress with High-Throughput

Oral Fluid Assays

Prototype tests for most of the assays

designated for the initial launch menu have

been developed

Initial performance shows good clinical

correlation with existing confirmatory algorithms

and excellent precision

Performance data on these prototypes was

presented at the 2007 Society for Forensic

Toxicologists (SOFT) meeting

2007 –

Confidential and Proprietary

Dose Response Curve and Cutoff for High

Throughput Oral Fluid Opiate Assay

Oral Fluid Cutoff Concentrations

*Oral fluid cutoff concentrations are for sample diluted by

diluent

the

Intercept®

Oral

Specimen

Collection

Device.

LDL, or analytical sensitivity, is defined as the lowest

drug concentration that can be distinguished from zero

calibrator with 95% confidence (2SD) and determined by

running 21 replicates of 0 calibrator and calculating the

mean and standard deviation (S.D.) of 21 results.

0.5

0-80

ng/mL

LDL

Dynamic Range

Cutoff

1000

2000

3000

4000

5000

Morphine Concentration, ng/mL

Opiates Assay Calibration

Curve on Roche/Hitachi 917

Source:

Hoch

al.

Society

Forensic

Toxicologists

2007

2007 –

Confidential and Proprietary

Accuracy of the High

Throughput Opiate Assay

200

OTI EIA Assay

(10 ng/mL)

Opiates Assay

(10 ng/mL)

A total of 200 individual clinical samples from a low risk

population that screened negative with the OraSure

Technologies, Inc ( OTI ) Micro-Plate assays

ere tested in the semi-quantitative mode with Opiates

automated assay.

115

35*

331

Sensitivity = 115 (115 + 2) =98.3%

Specificity = 331/ (331 + 35) =90.4%

LC/MS/MS

Opiate assay

(10 ng/mL)

*Of the 35 false positive results, 16 (46%) had

total opiates greater than 10 ng/mL. (any

combination).

Specificity in low

prevalence population:

Sensitivity in high

prevalence population:

Source: Hoch D et al. Society of Forensic Toxicologists 2007

2007 –

Confidential and Proprietary

Precision of the High

Throughput Opiate Assay

Opiate Assay Within Run Precision, n=21

Levels tested

Within Run Mean

Precision

Recovery

(ng/mL)

(% CV)

(%)

5.0

5.3

3.4

107

7.5

7.7

2.6

103

10.0

10.3

2.3

103

12.5

12.6

1.5

101

40.0

41.0

1.5

102

Source:

Hoch D et al. Society of Forensic Toxicologists

2007

2007 –

Confidential and Proprietary

Oral Fluid Cutoff Concentrations

*Oral fluid cutoff concentrations are for sample diluted

by diluent in the Intercept®

Oral Specimen Collection

Device.

LDL, or analytical sensitivity, is defined as the lowest

drug concentration that can be distinguished from zero

calibrator with 95% confidence (2SD) and determined

by running 21 replicates of 0 calibrator and calculating

the mean and standard deviation (S.D.) of 21 results.

Calibration Curves

Amphetamines Assay Calibration Curve on

Roche/Hitachi 917

1000

2000

3000

4000

5000

6000

7000

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

110.0

d-amphetamine Concentration, ng/mL

Methamphetamines Assay Calibration Curve on

Roche/Hitachi 917

1000

2000

3000

4000

5000

6000

7000

8000

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

d-methamphetamine Concentration, ng/mL

1.0

0.6

LDL

0-100

Dynamic Range

Cutoff

Methamp ng/mL

AMP ng/mL

Dose Response Curve and Cutoff for High

Throughput Oral Fluid Amphetamines and

Methamphetamines Assay

Source:

Mountain L, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

Precision of Amphetamines

and Methamphetamines Assay

Amphetamines Assay Within Run Precision, n=21

Levels tested

Within Run Mean

Precision

Recovery

(ng/mL)

(% CV)

(%)

12.5

12.9

2.8

104

30.0

30.1

1.7

100

40.0

40.9

1.3

102

50.0

52.2

1.3

104

Methamphetamines Assay Within Run Precision, n=21

Levels tested

Within Run Mean

Precision

Recovery

(ng/mL)

(% CV)

(%)

12.5

12.7

3.2

101

30.0

30.2

1.8

101

40.0

41.4

1.3

104

50.0

53.9

3.7

108

Source:

Mountain L, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

Specificity of Amphetamines

and Methamphetamines Assay

A total of 200 individual clinical samples from a low risk population that screened

negative with the OraSure Technologies, Inc ( OTI ) Micro-Plate assays were tested

in the semi-quantitative mode with Amphetamines and Methamphetamines

automated assays.

199

OTI EIA AMP Assay

(100 ng/mL)

AMP Assay

(40 ng/mL)

200

OTI EIA Methamp Assay

(40 ng/mL)

Methamp Assay

(40 ng/mL)

Source:

Mountain L, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

Sensitivity of Amphetamines

and Methamphetamines Assay

A total of 49 clinical samples from a drug prevalent population were tested in the semi-quantitative mode

with

the

automated

Amphetamine

and

Methamphetamine/MDMA

assays.

All

samples

were

also

tested

for the presence of d-amphetamine, d-methamphetamine, MDA, MDMA, and MDEA with LC/MS/MS.

The

LC/MS/MS

result

considered

positive

any

these

drugs

are

present

concentrations

ng/mL.

*The 18 samples that gave negative results on the amphetamines assay had concentrations of

methamphetamine $

ng/mL.

18*

LC/MS/MS

AMP assay

(40 ng/mL)

LC/MS/MS

Methamp assay

(40 ng/mL)

Source:

Mountain L, et al. Society of

Forensic Toxicologists 2007

2007 –

Confidential and Proprietary

Dose Response and Cutoff for High

Throughput Oral Fluid Cocaine Assay

Oral Fluid Cutoff Concentrations

*Oral fluid cutoff concentrations are for

sample diluted by diluent in the

Intercept®

Oral Specimen Collection

Device.

LDL, or analytical sensitivity, is defined

as the lowest drug concentration that can

be distinguished from zero calibrator with

95% confidence (2SD) and determined

by running 21 replicates of 0 calibrator

and calculating the mean and standard

deviation (S.D.) of 21 results.

Calibration Curves

Cocaine Assay Calibration Curve on

Roche/Hitachi 917

1000

2000

3000

4000

5000

6000

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

Benzoylecgonine Concentration, ng/mL

0-40

ng/mL

LDL

Dynamic

Range

Cutoff

Source:

Zhao J,, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

Precision of the Cocaine Assay

Cocaine Assay Within Run Precision, n=21

Levels tested

Within Run Mean

Precision

Recovery

(ng/mL)

(% CV)

(%)

2.25

2.5

2.6

112

3.2

2.8

105

3.75

3.9

2.9

103

5.0

2.1

100

6.25

6.2

1.8

30.6

1.0

102

Source:

Zhao J,, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

Accuracy of the Cocaine High

Throughput Assay

•A total of 560 clinical sample pools from a drug prevalent population were tested in the

semi-quantitative

mode

with

the

automated

cocaine

assay.

All

samples

were

also

tested

for the presence of benzoylecgonine with LC/MS/MS.

377

2**

177

Sensitivity = 377/ (377 + 2) =99.5%

Specificity = 177/ (177 + 4) =97.8%

LC/MS/MS

Cocaine assay

(3 ng/mL)

(2 ng/mL)

2 of the 4 discrepant samples

that had tested positive on the

automated assay contained trace

amounts of benzoylecgonine.

The 2 false negatives gave

values of 1.41 and 2.56 ng/mL on

the automated assay.

Source:

Zhao J,, et al. Society of Forensic

Toxicologists 2007

2007 –

Confidential and Proprietary

High-Throughput Oral Fluid

Assays High level Milestones

Conduct alpha studies with prototype

assays at customer sites

Complete feasibility and finalize design

Develop calibrators and controls

Conduct technology transfer

Complete 510K testing

Inventory build and launch

2007 –

Confidential and Proprietary

OraQuick

HIV Shelf Life Improvement

Current

Status

•

Product modifications to support longer shelf life have

already been implemented and verified

•

Proposed modifications do not require additional clinical

trials

•

Currently conducting real-time validation/stability studies

using GMP material

•

These studies utilize 3 production lots containing all

proposed modifications

•

Real-time stability testing to continue throughout the year

Just successfully passed 6 month time point

•

Target for shelf life is >12 months (dependent upon

generating real time stability data)

2007 –

Confidential and Proprietary

Strategy for Shelf Life Extension

Shelf life extension will occur in unregulated

markets upon successful completion of stability

testing and process validation

Shelf life in US and EU will be extended after

approval of the appropriate regulatory

submissions.

Additional submissions will be made in certain

geographies where required

Our goal is to extend product shelf life in all

geographies in 2008

Questions and Answers

2007 –

Confidential and Proprietary

Regulatory Affairs/ Quality Assurance/

Clinical Trials Overview

Sue Sutton-Jones

SVP, RA/QA

2007 –

Confidential and Proprietary

Key Role in Bringing Products

to Market

RA/CA/QA play a role in the product lifecycle

from conception through to obsolesce of the

product.

•

Strategy

•

Negotiation

•

Organization

•

Subject Matter Experts

•

Archivists

•

Business Partners

•

Looked on by many regulators as the “conscience of a

Company”, our credibility is the credibility of the

Company

2007 –

Confidential and Proprietary

RA/QA/CA Submission Activities

2007

QTR 1

QTR 2

QTR 3

QTR 4

IDE

FDA Submissions

Int'l Submissions

Audits

Protocols/Amendments

Study Conduct

Analyses

Reports

Over 200 submissions and

responses so far this year.

2007 –

Confidential and Proprietary

Some

of Our International Activities

CE Mark Achieved for OraQuick

Dossiers/Documentation

•

Individual EU countries

•

Argentina

•

Brazil

•

Ecuador

•

Guatemala

•

Israel

•

Russia

•

Vietnam

•

Thailand

•

South Korea

•

China

•

Mexico

•

Philippines

•

Indonesia

•

UAE

•

Validations in multiple

African Countries

2007 –

Confidential and Proprietary

OraQuick®

ADVANCE

HIV-1/2

Antibody

Test

OVER-THE-COUNTER APPLICATION

2007 –

Confidential and Proprietary

Regulatory Update for HIV OTC

Panel track submission

Premarket approval is required (PMA)

The PMA will be reviewed by the Center for

Biologic Evaluation and Research (CBER). We

expect the PMA will also be presented to an FDA

advisory panel for review and comment.

2007 –

Confidential and Proprietary

Clinical Study Considerations

In designing the proposed program, OraSure

gave special consideration to a number of topics:

•

All

protocols

must

able

demonstrate

that

the

product

meets

the

criteria defined at the March 10, 2006 BPAC meeting;

•

The population expected to use the OTC product;

•

Creation of easy to read and understand instructions for use;

•

User friendly packaging and presentation of the product;

3 Phased Approach to Clinical Studies

•

Label Comprehension and Reading Contrived Devices

•

Where the subject does not self test

•

Observed Use

•

Subject observed performing the test.

•

Unobserved Use

•

Subject performs tests in uncontrolled environment

2007 –

Confidential and Proprietary

Label Comprehension

Label Comprehension Study

Status -

completed

•

Performed after refining labeling and

instructions through pre-testing

•

Tests target population understanding of

the instruction materials

•

Subjects do not conduct a test with an

actual device

2007 –

Confidential and Proprietary

Reading Contrived Devices

The purpose of the study is to demonstrate that

individuals from the target population are able to

accurately interpret various test result.

In this study, subjects selected from the target

population are given contrived devices to read and

interpret the results

The subjects in this study do not test themselves and

the devices used are “dummy”

devices that are not

infectious.

2007 –

Confidential and Proprietary

Observed Use

•

The subjects will be selected according to the

demographics of the end users identified for this product.

•

Subjects will be given the test kit and provided with a

setting in which to take the test on their own.

•

Subjects will be observed ( through glass) while

performing the test and their test result will be compared

to the result from a trained professional.

•

This study is observed so that the actual use of the test

kit by a “consumer”

can be documented prior to allowing

subjects to take the kit in a setting of their choice.

•

Subjects will be interviewed about their experience with

the test after they have completed running and

interpreting their own test.

2007 –

Confidential and Proprietary

Unobserved Use

•

Subjects will be screened per the protocol and a sample

taken to determine their HIV status.

•

Subjects will be given the test kit and asked to take the

test and report back to the clinical study site within a

week. (Subjects will provide contact information prior to

being given a test kit to leave the clinical site so that we

may conduct follow up.)

•

Subjects will report their HIV test results, which will be

compared to the professional determination of their

status.

•

Questions about their experience performing the test

will be asked during an interview conducted when they

return with their result.

2007 –

Confidential and Proprietary

Referral to Care and Resource

Answer Center

For the referral and resource program we will at

minimum include the key points of the CDC Guidelines

for HIV Counseling.

For the observed and unobserved phases, the

counseling system will have functional capabilities

intended for launch.

1-800# number access.

According to standard CDC recommended guidelines.

Call agents, methods, as intended launch.

Will not be operating on full intended commercial scale.

2007 –

Confidential and Proprietary

OTC Milestones

2008

FDA Submission

Complete

Referral to Care and

Resource Answer System

Protocol written and to be submitted to FDA by end Q1 2008

Study to be executed in 2008

Unobserved User Study

Protocol written and to be submitted to FDA by end Q4 2007

Study to be executed in 2008

Observed User Study

Complete

Reading Contrived Devices

Complete

Robust Comprehension

Status

Task

2007 –

Confidential and Proprietary

OraQuick

HCV Test

Clinical Study Update

2007 –

Confidential and Proprietary

HCV Regulatory Update

Submission reviewed by Center for Devices and

Radiological Health (CDRH)

PMA for a rapid test for HCV

180 day review time estimated

Clinical trials are straightforward and

uncomplicated.

2007 –

Confidential and Proprietary

HCV Rapid Test

Human Subject Clinical Trial

Population

•

Thousands of subjects with signs and symptoms of

Hepatitis, or at high HCV infection risk

•

Hundreds of asymptomatic subjects

Inclusion / exclusion criteria

•

Either gender, $

yrs of age, informed consent

•

No subjects <2 yrs, therapy for HCV infection

Test via comparator methods

•

(FDA approved EIA, RIBA)

2007 –

Confidential and Proprietary

CLIA Waiver Trial

Trial to establish appropriate device

characteristics for CLIA-waiver

Minimum of 3 U.S. centers

(consistent with point-of-care testing)

Patients consistent with expected use

Test via comparator method (FDA approved EIA,

RIBA) blinded from operator

OraQuick

testing by operator

2007 –

Confidential and Proprietary

Studies Required for FDA

Approval of the HCV Rapid Test

2008

FDA, CLIA, CE Mark Submissions

Q4 2007 to begin

Clinical performance in human subjects

Complete

Anticoagulants

Complete

Interfering substances

Complete

Food and Beverage

Complete

Genotypes

Complete

Unrelated medical conditions

Complete

Seroconversion

Complete

Feasibility

Status

Task

2007 –

Confidential and Proprietary

2007 Cryosurgical Device

Clinical Study

2007 –

Confidential and Proprietary

Cryosurgical

Clinical / Regulatory Efforts

Clinical Study to expand the claims for an over the

counter cryosurgical system were begun in Q3.

The last subject will exit the study the end of this

month.

We are targeting to submit the 510k in Q1 2008.

This will increase our offerings for an over the

counter cryosurgical product to three applications.

Questions and Answers

Sales & Marketing Overview

Joseph E. Zack

EVP –

Sales & Marketing

17 Million Potential Tests for OraQuick

Hospitals

Public Health

MD Offices

Government Programs

Source: Company Estimates based on Industry Reports.

* Excludes OTC market and impact of CDC guideline

changes and new program announcement.

U.S. Market Potential:

HIV Tests *

Diverse Customer Base Potential

•

Advocate Routine Voluntary

HIV screening 13-64 yrs

•

De-stigmatize HIV testing

process

•

Emphasize cost

effectiveness of testing in all

ranges of prevalence

•

Promote opt-out testing

models

•

Increase diagnosis of HIV

•

Decrease time for testing

procedure

•

Known positives reduce

unsafe practices

•

Bottom line….early detection

reduces transmission

CDC Revised Recommendations

Background Rationale for Revision

CDC Initiative

CDC Opportunity

–

CDC redirected $45 million in funding to

expand HIV testing

–

Program goal is to test 1.0 million persons for

HIV

–

23 jurisdictions awarded approximately $35

million

–

Individual grant size: $600K -

$6MM

–

Program will be for 3 years

The 23 Jurisdictions

California

Chicago

Connecticut

District of Columbia

Florida

Georgia

Houston

LA County

Louisiana

Maryland

Massachusetts

Grant Recipients

Michigan

Missouri

New Jersey

New York City

New York State

North Carolina

Ohio

Pennsylvania

Philadelphia

South Carolina

Tennessee

Virginia

CDC Initiative Status

Working with each of the jurisdictions closely

Tracking implementation

Bulk of Revenues expected in 2008

Prevention initiatives within U.S. Hospitals

•

20% of pregnant women don’t know their status

•

Vertical transmission accounts for 100% of all pediatric infections –

98% could have been prevented

•

1 million needle stick injuries annually; 16,000 result in HIV exposure²

•

More than 55% of patients tested in the ER are discharged prior to

receiving their HIV test results

•

Only 10% of patients referred out to hospital clinics from ER

Departments actually undergo testing

•

Conversely, when rapid testing was performed, 99.3% of patients

received their results; 80% of them entered into care.

Revised

Guidelines

for

HIV

Counseling,

Testing,

and

Referral

and

Revised

Recommendations

for

HIV

Screening

Pregnant

Women,

MMWR,

Vol.

50/No.

RR-19,

November

2001.

2. American Nurses Association, Needlestick Injury, http://www.nursingworld.org, 2002.

3. CDC, 2002.

4. Only 10% of Patients Referred Out to Hospital Clinics from ER Departments Actually Undergo Testing, Dr. Roger Lewis, Harbor UCLA Medical Center, Reuters Health, 2001.

Demand for Prevention in U.S.

Continued Increase in HIV Testing

FY03 –

FY05 Outpatient Only

FY06-07 Outpatient, Inpatient and ED

92,123

56,212

53,598

58,785

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

FY03

FY04

FY05

FY06

110,000

120,000

130,000

140,000

132,641

FY07

92,123

56,212

53,598

58,785

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

FY03

FY04

FY05

FY06

110,000

120,000

130,000

140,000

132,641

FY07

Impact on HIV Prevention

HIV Testing Expansion Initiative

New York City Health and Hospitals Corp

CDC, Dr. Bernie Branson

PACHA Meeting, October 15-16, 2007

Number of HIV-Positive Persons Identified More than Doubled

FY03 –

FY04 Outpatient Only

FY05 Outpatient and ED Pilot Sites Only

FY06-07 Outpatient, Inpatient and ED

815

670

720

1,514

200

400

600

800

1,000

1,200

1,400

1,600

FY03

FY04

FY05

FY06

1,618

FY07

815

670

720

1,514

200

400

600

800

1,000

1,200

1,400

1,600

FY03

FY04

FY05

FY06

1,618

FY07

Impact on HIV Prevention

HIV Testing Expansion Initiative

New York City Health and Hospitals Corp

CDC, Dr. Bernie Branson

PACHA Meeting, October 15-16, 2007

•

OraQuick testing in the ED (2002)

–

62% accept HIV testing

–

98% receive test results

–

3,802 patients screened

–

93 (2.4%) new HIV positive

–

80% entered HIV care

•

Test Performance

–

Sensitivity 100%

–

Specificity 99.94%

OraQuick

ADVANCE

™

Impact on HIV Prevention

•

42% of patients tested had never

been screened for HIV

•

42% of positive patients had no

risk factors that would prompt their

physician to screen them for HIV

•

34% identified as MSM

•

10% identified as IDU

•

3% identified as having a partner

who was an IDU

Cook County Hospital

Journal Acquired Immune Deficiency Syndromes 2007

“The ER is a good place to perform HIV testing”

42%

30%

13%

10%

20%

30%

40%

50%

Strongly

agree

Agree

No opinion

Disagree

Strongly

disagree

No answer

Preliminary data, 680 pts -

GWU Hospital ED

What do patients think?

Impact on HIV Prevention

CDC, Dr. Bernie Branson

PACHA Meeting, October 15-16, 2007

Would you

recommend to a friend

to get an HIV test if

they went to the ER?

84%

30%

60%

90%

Yes

Preliminary data, 680

pts

GWU Hospital ED

What do patients think?

Impact on HIV Prevention

CDC, Dr. Bernie Branson

PACHA Meeting, October 15-16, 2007

Social Marketing Program

City Initiatives

Objective

Collaborate with local constituencies to ensure

residents know their HIV status

–

Washington DC

–

Philadelphia

™

COMING

TOGETHER

DC –

Results to Date

–

DC Data*

–

the

end

2006,

HAA

(HIV/AIDS

Administration)

saw

75% percent increase in overall HIV screening in the

District, yielding a 3.5% positivity rate.

–

As of September 30, 2006, more than 16,700 residents

tested with 580 preliminary positive results (approx. 3.47%

rate).

–

Over 550 persons trained to offer HIV screening in public

health and hospital settings.

–

In 2005, HAA averaged approximately 27,000 HIV tests per

year, since then they have increased testing to

approximately 96,000 tests per year

*Come Together DC –

Get Screened for HIV Progress Report. Obtained from CDC Application for grant opportunity CDC-PS07-768

Philadelphia

City-wide rapid HIV testing initiative

State Senator Hughes, PA Secretary Johnson, PHL

Commissioner Paris, AACO Director Cella

$1.5 million state grant

Largest amount awarded to HIV/AIDS program in

State history

Focus on traditionally underserved populations

Support recently released CDC guidelines

Europe

•

OraQuick

•

Cryo –

OTC & Rx

•

Substance Abuse

China

•

OraQuick

•

Cryo –

Africa

•

OraQuick

Caribbean

•

OraQuick

South America

•

OraQuick

•

Cryo –

•

Cryo –

OTC

Australia

•

Cryo –

OTC

Mexico

•

OraQuick

•

Cryo –

•

Cryo –

OTC

Canada

•

Cryo –

OTC

Global Expansion

Questions and Answers

Operations Overview

P. Michael Formica

EVP -

Operations

Total:

117,000

Bethlehem Buildings

Tech III Headquarters

(48,000

ft²)

North

Building

(32,000

ft²)

South

Building

(37,000

ft²)

(Acquired in 2006)

(Acquired in 1997)

(Acquired in 2006)

Space Allocation

Total

117,000 sq ft

Manufacturing

50,500

sq ft

Clean Rooms

15,500

sq ft

Warehouse

11,000

sq ft

Office Space

40,000 sq ft

Facility/Capacity Long Range Plan

Joint Analysis with Facility Planning

Consultants

2008 –

2011

Facilities and Infrastructure Analysis

Production Line/ Production Process Capacity

Analysis

Review of Off-Shore Manufacturing Strategy

OraQuick Capacity Plan

Based on Multiple Production Lines

Semi-Automated Assembly Lines

Automation Assembly Lines

Off-Shore Production Capacity

Tech III Building (48,000 sq ft)

Corporate Headquarters

Finance & Accounting

Operations Department

Oral Fluid Collection Manufacturing

Assay Formulations

OraQuick Assembly

Control Warehouse (Shipping & Receiving)

North Building (32,000 sq ft)

Assay Formulations

Assay Assembly

OraQuick

Device Assembly

QC Laboratory

Vial Filling

QED

Micro-plate Coating/ Pouching

South Building (37,000 sq ft)

Sales & Marketing

Research & Development Laboratory

Research & Development Staff

Regulatory & Quality Assurance & Clinical Trials

IT/ MIS Staff

Aerial View of Tech III Campus

OraQuick International Supply Chain

Bethlehem

•FDA Product

•CE Product

•International, Export Market

(Non Approved Product)

Thailand

•International, Non-FDA Product

(Supply

Raw material

To Thailand)

SAP Installation Update

Modules Installed:

FICO –

Finance & Controlling

MM –

Materials Management

PP –

Production Planning

QM –

Quality Management

SD –

Sales & Distribution

WM –

Warehouse Management

Present Focus

Utilize System Capabilities to Improve Processes

Summary

Facility Planning Driven by Strategic Analysis

Facilities & Infrastructure in place for growth

Facilities Expansion Possible if Needed

Questions and Answers

OraSure Technologies, Inc.

Thank You

OraQuick ADVANCE

Histofreezer

OraSure

Intercept

OraSure (OSUR) 8-KRegulation FD Disclosure