UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 28, 2007
OraSure Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-16537 | 36-4370966 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 220 East First Street Bethlehem, Pennsylvania |
18015-1360 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: 610-882-1820
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 – Regulation FD Disclosure.
On November 28, 2007, OraSure Technologies, Inc. (the “Company”) will host an Analyst Day meeting in New York, New York, at the NASDAQ MarketSite at Times Square. At the meeting the Company’s senior executive team will make presentations to analysts using slides containing the information attached to this Current Report on Form 8-K as Exhibit 99.1. The fact that these presentation materials are being furnished should not be deemed an admission as to the materiality of any information contained therein. The information contained in the slides is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission filings and other public announcements that the Company has made or may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report.
This information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 – Financial Statements and Exhibits.
| (d) | Exhibits |
| Exhibit Number |
Description | |
| 99.1 | Slide show presentation to be used by OraSure Technologies, Inc. on November 28, 2007 | |
Signatures
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| ORASURE TECHNOLOGIES, INC. | ||||||||
| Date: November 28, 2007 | By: | /s/ Jack E. Jerrett | ||||||
| Jack E. Jerrett | ||||||||
| Senior Vice President, General Counsel | ||||||||
| and Secretary | ||||||||
Exhibit Index
| Exhibit Number |
Description | |
| 99.1 | Slide show presentation to be used by OraSure Technologies, Inc. on November 28, 2007 | |
 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 These slides and the associated presentation contain certain forward-looking statements, including statements with respect forward-looking statements, including statements with respect to revenues, earnings, technology, new products, product to revenues, earnings, technology, new products, product performance, markets, regulatory filings and approvals, and performance, markets, regulatory filings and approvals, and business plans. Factors affecting these statements include, business plans. Factors affecting these statements include, but are not limited to, the ability to develop new technology, but are not limited to, the ability to develop new technology, technology changes, ability to fund research and technology changes, ability to fund research and development, required regulatory approvals, product development, required regulatory approvals, product performance and market acceptance of products. Please see performance and market acceptance of products. Please see the Company’s SEC filings, including its registration the Company’s SEC filings, including its registration statements, and the Company’s most recent Form 10-K and statements, and the Company’s most recent Form 10-K and Form 10-Q, for a more detailed description of specific factors Form 10-Q, for a more detailed description of specific factors that may cause actual results or events to differ materially that may cause actual results or events to differ materially from those described in the forward-looking statements. The from those described in the forward-looking statements. The Company undertakes no duty to update these statements. Company undertakes no duty to update these statements. |
 2 AGENDA Analyst Day 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 |
 4 © 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 of OraQuick ® ADVANCE™ HIV Test • Clinical and Regulatory Studies for OraQuick ® HIV OTC • Label expansion of OTC cryosurgery indications |
 5 © 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 GL et al. (2006) Ann. Intern. Med. 144:705-714 Scott JD & Gretch DR (2007) JAMA 297:724-732 |
 6 © 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 |
 7 © 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. |
 8 © 2007 – Confidential and Proprietary TEST COLLECT 99.6% 100.0% Oral Fluid Oral Fluid Venipuncture Venipuncture Whole Blood Whole Blood Plasma & Plasma & Serum Serum Fingerstick Fingerstick Whole Blood Whole Blood A Simple Test Procedure Utilizing All Sample Types MIX |
 9 © 2007 – Confidential and Proprietary Prototype OraQuick ® HCV Test- Interpretation Non-reactive: Single line appears at 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. |
 10 © 2007 – Confidential and Proprietary Sensitivity of the Prototype OraQuick ® HCV Test in Known Infected Individuals 100% 47 47 Chronic HCV Infection 100% 33 33 HIV/HCV Coinfected Patients 100% 466 466 HCV (RIBA) Positive Plasma Donors 100% 93 93 Intra-venous Drug Users Sensitivity (%) No. Reactive by OraQuick ® N* Specimen Type 1 Plasma Specimens *No. of EIA reactive specimens tested Lee SR et al. AACC, 2007 Source: Lee SR et al. AACC, 2007 |
 11 © 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 10 0 12 22 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 of Panels Tested * 95% Confidence Intervals Lee SR et al. AACC, 2007 Source: Lee SR et al. AACC, 2007 |
 12 © 2007 – Confidential and Proprietary Sensitivity in Known HCV Positive Subjects Tested Using Oral Fluid and Whole Blood 92 (100%) 92 (100%) 92 (100%) 92 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 SR et al. AACC, 2007 |
 13 © 2007 – Confidential and Proprietary HCV ELISA + + - - 1 b 415 0 3 a 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 |
 14 © 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 |
 15 © 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
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 16 © 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 |
 17 © 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 |
 18 © 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 |
 19 © 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 |
 20 © 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 |
 21 © 2007 – Confidential and Proprietary Dose Response Curve and Cutoff for High Throughput Oral Fluid Opiate Assay Oral Fluid Cutoff Concentrations 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. 0.5 0-80 10 ng/mL ng/mL ng/mL LDL Dynamic Range Cutoff 0 1000 2000 3000 4000 5000 0 10 20 30 40 50 60 70 80 Morphine Concentration, ng/mL Opiates Assay Calibration Opiates Assay Calibration Curve on Roche/Hitachi 917 Curve on Roche/Hitachi 917 Source: Hoch D et al. Society of Forensic Toxicologists 2007 |
 22 © 2007 – Confidential and Proprietary Accuracy of the High Throughput Opiate Assay + - + 0 0 - 0 200 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* - 2 331 Sensitivity = 115 (115 + 2) =98.3% Specificity = 331/ (331 + 35) =90.4% LC/MS/MS Opiate assay (10 ng/mL) (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
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 23 © 2007 – Confidential and Proprietary Precision of the High Throughput Opiate Assay Opiate Assay Within Run Precision, n=21 Opiate Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (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 |
 24 © 2007 – Confidential and Proprietary Oral Fluid Cutoff Concentrations 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 Calibration Curves Amphetamines Assay Calibration Curve on Roche/Hitachi 917 0 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 0 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 0-100 Dynamic Range 40 40 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 |
 25 © 2007 – Confidential and Proprietary Precision of Amphetamines and Methamphetamines Assay Amphetamines Assay Within Run Precision, n=21 Amphetamines Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (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 Methamphetamines Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (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 |
 26 © 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. + - + 0 1 - 0 199 OTI EIA AMP Assay (100 ng/mL) AMP Assay (40 ng/mL) + - + 0 0 - 0 200 OTI EIA Methamp Assay (40 ng/mL) Methamp Assay (40 ng/mL) Source: Mountain L, et al. Society of Forensic Toxicologists 2007 |
 27 © 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 is considered positive if any of these drugs are present at concentrations $ 40 ng/mL. *The 18 samples that gave negative results on the amphetamines assay had concentrations
of methamphetamine $ 40 ng/mL. + - + 31 0 - 18* 0 LC/MS/MS AMP assay (40 ng/mL) (40 ng/mL) + - + 49 0 - 0 0 LC/MS/MS Methamp assay (40 ng/mL) (40 ng/mL) Source: Mountain L, et al. Society of Forensic Toxicologists 2007 |
 28 © 2007 – Confidential and Proprietary Dose Response and Cutoff for High Throughput Oral Fluid Cocaine Assay Oral Fluid Cutoff Concentrations 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 Calibration Curves Cocaine Assay Calibration Curve on Roche/Hitachi 917 0 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 03 0-40 3 ng/mL ng/mL ng/mL LDL Dynamic Range Cutoff Source: Zhao J,, et al. Society of Forensic Toxicologists 2007 |
 29 © 2007 – Confidential and Proprietary Precision of the Cocaine Assay Cocaine Assay Within Run Precision, n=21 Cocaine Assay Within Run Precision, n=21 Levels tested Within Run Mean Precision Recovery (ng/mL) (ng/mL) (% CV) (%) 2.25 2.5 2.6 112 3 3.2 2.8 105 3.75 3.9 2.9 103 5 5.0 2.1 100 6.25 6.2 1.8 99 30 30.6 1.0 102 Source: Zhao J,, et al. Society of Forensic Toxicologists 2007 |
 30 © 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 4* - 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 |
 31 © 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 |
 32 © 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) |
 33 © 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 |
 36 © 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 |
 37 © 2007 – Confidential and Proprietary RA/QA/CA Submission Activities 2007 0 5 10 15 20 25 30 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. |
 38 © 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 |
 39 © 2007 – Confidential and Proprietary OraQuick® ADVANCE HIV-1/2 Antibody Test OVER-THE-COUNTER APPLICATION |
 40 © 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. |
 41 © 2007 – Confidential and Proprietary Clinical Study Considerations In designing the proposed program, OraSure gave special consideration to a number of topics: • All protocols must be able to 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 |
 42 © 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 |
 43 © 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. |
 44 © 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. |
 45 © 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. |
 46 © 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. |
 47 © 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 |
 48 © 2007 – Confidential and Proprietary OraQuick ® HCV Test Clinical Study Update |
 49 © 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. |
 50 © 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, $
2 yrs of age, informed consent • No subjects <2 yrs, therapy for HCV infection Test via comparator methods • (FDA approved EIA, RIBA) |
 51 © 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 |
 52 © 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 |
 54 © 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.
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 Questions and Answers |
 56 Sales & Marketing Overview Joseph E. Zack EVP – Sales & Marketing |
 57 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 |
 58 • 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 |
 59 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 |
 60 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 |
 61 CDC Initiative Status Working with each of the jurisdictions closely Tracking implementation Bulk of Revenues expected in 2008 |
 62 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 • 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 3 • Only 10% of patients referred out to hospital clinics from ER Departments actually undergo testing 4 • Conversely, when rapid testing was performed, 99.3% of patients received their results; 80% of them entered into care. 1. Revised Guidelines for HIV Counseling, Testing, and Referral and Revised Recommendations for HIV Screening of Pregnant Women, MMWR, Vol. 50/No. RR-19, November 9, 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. |
 63 Continued Increase in HIV Testing FY03 – FY05 Outpatient Only FY06-07 Outpatient, Inpatient and ED 92,123 56,212 53,598 58,785 0 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 0 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 |
 64 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 0 200 400 600 800 1,000 1,200 1,400 1,600 FY03 FY04 FY05 FY06 1,618 FY07 815 670 720 1,514 0 200 400 600 800 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 |
 65 • 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 |
 66 “The ER is a good place to perform HIV testing” 42% 30% 13% 3% 5% 6% 0% 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 |
 67 Would you recommend to a friend to get an HIV test if they went to the ER? 84% 9% 0% 30% 60% 90% Yes No - 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 |
 68 Social Marketing Program City Initiatives Objective Collaborate with local constituencies to ensure residents know their HIV status – Washington DC – Philadelphia ™ COMING TOGETHER TO |
 69 DC – Results to Date * – DC Data* – At the end of 2006, HAA (HIV/AIDS Administration) saw a 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 |
 70 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 |
 71 Europe • OraQuick • Cryo – OTC & Rx • Substance Abuse China • OraQuick • Cryo – Rx Africa • OraQuick Caribbean • OraQuick South America • OraQuick • Cryo – Rx • Cryo – OTC Australia • Cryo – OTC Mexico • OraQuick • Cryo – Rx • Cryo – OTC Canada • Cryo – OTC Global Expansion |
 72 Questions and Answers |
 73 Operations Overview P. Michael Formica EVP - Operations |
 74 Total: Total: 117,000 ft 2 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) |
 75 Space Allocation Total 117,000 sq ft 117,000 sq ft Manufacturing Manufacturing 50,500 sq ft Clean Rooms Clean Rooms 15,500 sq ft Warehouse Warehouse 11,000 sq ft Office Space Office Space 40,000 sq ft |
 76 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 |
 77 OraQuick Capacity Plan Based on Multiple Production Lines Semi-Automated Assembly Lines Automation Assembly Lines Off-Shore Production Capacity |
 78 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) |
 79 North Building (32,000 sq ft) Assay Formulations Assay Assembly OraQuick Device Assembly QC Laboratory Vial Filling QED Micro-plate Coating/ Pouching |
 80 South Building (37,000 sq ft) Sales & Marketing Research & Development Laboratory Research & Development Staff Regulatory & Quality Assurance & Clinical Trials IT/ MIS Staff |
 81 Aerial View of Tech III Campus |
 82 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) |
 83 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 |
 84 Summary Summary Facility Planning Driven by Strategic Analysis Facilities & Infrastructure in place for growth Facilities Expansion Possible if Needed |
 85 Questions and Answers |
 OraSure Technologies, Inc. Thank You OraQuick ADVANCE ® Histofreezer ® OraSure ® Intercept ® |